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Search Results Within Category "Brain & Nervous System"

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Research Evaluating Vagal Excitation and Anatomical Links

We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.

Principal Investigator: John Osborn Jr.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00002000
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
Exclusion Criteria:

• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
Conditions: Brain & Nervous System, Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Depression, Epilepsy, Vagal Nerve Stimulator, VNS
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A Pivotal Study Evaluating Safety and Efficacy of the ShiraTronics Migraine Therapy System in RELIEVing, Interrupting, and Preventing Chronic Migraine (RELIEV-CM2)

This research study is testing a potential new treatment for refractory chronic migraine (RCM). The potential new treatment is called ShiraTronics Migraine Therapy. The purpose of this study is to demonstrate the safety and effectiveness of the ShiraTronics Migraine Therapy System. The ShiraTronics System delivers mild electrical pulses to nerves associated with migraine pain around the back and front of your head. These electrical pulses interrupt or change the transmission of pain signals to the brain, which can potentially relieve your chronic migraine pain and symptoms. The ShiraTronics System is approved by the United States Food and Drug Administration for investigational (under research) use, and not approved for sale.

Principal Investigator: Abby Metzler
Age Group: 18 years and over
IRB Number: STUDY00022988
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• at least 22 years old
• migraines started before 50 years old
• migraines occurring for at least 12 months before starting the study
• 15 - 26 headache days/month, among which ≥ 8 days has the features of probable migraine, and minimum of 2 headache-free days/month
• use of preventive(s) migraine medication for at least 3 months before starting the study
Exclusion Criteria:

• headache or migraine other than refractory chronic migraine (RCM)
• previously implanted neurostimulator
• received botulinumtoxinA (Botox) for any other medical or cosmetic reasons requiring injections in the head, face, or neck within the past 3 months
• cervical radiofrequency ablation within 12 months
• other implanted electrical stimulation device or any metallic implant located in the head including CSF shunt and surgical clip above the shoulder line (excluding dental implants)
• women who are pregnant or breastfeeding or planning a pregnancy during participation in the study
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), chronic headache, Migraine Headache, Neurostimulator
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A Window of Opportunity Trial of Mirdametinib plus Vorinostat for NF1 Associated, Malignant Peripheral Nerve Sheath Tumor; MPNST (Le-Na)

This is a small, Phase 0, window of opportunity study to provide human experience to support our pre-clinical data and gain preliminary information regarding the safety and tolerability of mirdametinib and vorinostat when given in combination.

Principal Investigator: Robert Galvin
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022372
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria
• Diagnosis of suspected MPNST by PET or MRI imaging
• Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry
• Twelve years of age or older - Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1st dose of study drug
• Must be able to swallow capsules
• Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib
• Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat
• Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment
Exclusion Criteria:

• Pregnant or breastfeeding – females of childbearing potential must have a negative pregnancy test (serum and urine) within 7 days prior to the 1st dose of the study drugs
• Significant cardiac disease
• Ophthalmologic conditions
• Radiation therapy or chemotherapy in the past year
• Participants receiving systemic or ocular glucocorticoid therapy within 14 days prior to the first dose of study treatment
Conditions: Brain & Nervous System
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Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM sleep Behavior Disorder

This research is being completed to examine the cells, brain imaging, and speech in individuals with REM Sleep Behavior Disorder who are taking serotonergic medications such as Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine and Sertraline. The purpose of examining these is to try and see if we can predict signs of Dementia with Lewy bodies (a progressive form of dementia with an increase in decline of thinking, reasoning, and other functions). This may benefit others by enabling us to diagnose Dementia with Lewy Bodies sooner rather than later.

Principal Investigator: Michael Howell
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019626
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• diagnosis of polysomnogram-confirmed RBD (e.g. narcolepsy) with history of dream enactment or clear dream enactment visualized on video from polysomnogram
• dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication
• for Healthy Volunteers: on serotonergic medication for at least 6 months without history of dream enactment
• the following serotonergic medications are included for both groups: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline
Exclusion Criteria:

• Parkinsons disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimers disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
• untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
• unable to have a MRI scan
• women who are pregnant
• for Healthy Volunteers: same exclusion criteria as those with 5-HT RBD group, plus history of dream enactment, or increased REM motor tone
Conditions: Rare Diseases, Brain & Nervous System
Keywords: dream enactment, Serotonergic REM sleep behavior
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PREVENT ALL ALS

Individuals who are carriers of ALS causative gene variants have an increased lifetime risk of developing ALS or a related disorder, Frontotemporal Dementia (FTD). We are doing this research to collect a wide range of biofluid samples, clinical information, and other health and wellbeing information to look for measurable differences that will help us understand how and when the body changes in response to ALS causative gene variants.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023161
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• first-degree relative of a known carrier of any Amyotrophic Lateral Sclerosis (ALS) causative gene1 (regardless of whether ALS or Frontotemporal Dementia FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and/or FTD in a family with a "compelling family history" of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members. A "compelling family history" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.
• access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)
Exclusion Criteria:

• evidence of neurological signs or symptoms concerning for ALS of FTD
• significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days (about 3 months)
• clinically significant, unstable medical condition
Conditions: Rare Diseases, Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), ALS, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, FTD
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Vasomotor symptoms of menopause and cardiovascular disease: What is the link?

Study to examine the physiological responses that occur during a hot flush in postmenopausal women

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013742
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:
Participants must have completed menopause and experience either no menopausal hot flashes or experience three menopausal hot flashes a day.
Exclusion Criteria:

• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ≥ 35 kg/m2
Conditions: Blood Disorders, Brain & Nervous System, Women's Health
Keywords: autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats
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A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.

Principal Investigator: Lindsey Sloan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000958
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
Exclusion Criteria:

• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
Conditions: Brain & Nervous System, Cancer
Keywords: Brain Tumor
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ASSESS ALL ALS Study

We are doing this research to collect a wide range of samples, clinical information, and measurements that will be used for future research into ALS and related neurological diseases. Participants will be asked to complete 7 in-person study visits and monthly remote self-assessment activities. Access to a personal device (computer and/or smartphone or tablet) that is connected to the internet is needed to complete the monthly remote activities.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023160
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Amyotrophic Lateral Sclerosis (ALS) by a physician
• access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient
• for HEALTHY participants: no diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS), no family history ALS/Frontotemporal Dementia (FTD) in a close family member** unless the participant has previously tested negative for the known causative ALS genes, and access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient
• see link to clinicaltrials.gov
Exclusion Criteria:

• cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days of starting the study,
• clinically significant unstable medical condition
Conditions: Brain & Nervous System, Rare Diseases
Keywords: ALS, Amyotrophic Lateral Sclerosis, Clinics and Surgery Center (CSC)
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Sleep Outcomes with DBS Therapy in Parkinson's Disease and Dystonia

The objective of this study is to describe how activation of distinct pathways in and around the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS) surgery targeting these structures.

Principal Investigator: Luke Johnson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018981
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 21 years old
• existing or planned 7T brain imaging
• surgery at UMN to implant DBS system planned as part of routine clinical care (or has already occurred, as long as the first programming session is at least 2 weeks away)
Exclusion Criteria:

• other significant neurological disorder
• history of dementia
• complications after surgery
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Parkinson's Disease, Sleep Apnea
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Udall P1A4

Through this research, the study staff hopes to better understand how DBS works and to define the optimal site in the brain for DBS treatment for Parkinson’s Disease. You will be asked to come for one study visit where you will perform some physical and mental tasks while on and temporarily off your medications and DBS treatment. Participation in this research study will take 7-8 hours.

Principal Investigator: Jerrold Vitek
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019735
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 10 years old
• diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia
• implanted Deep Brain Stimulator (DBS)
• have a 7T MRI
Exclusion Criteria:

• history of dementia
• women who are pregnant or breastfeeding
• other exclusion criteria (study staff will review)
Conditions: Brain & Nervous System
Keywords: DBS, Dystonia, Essential Tremor, ET, Movement Disorders, Parkinson's, Parkinson's Disease, PD
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Coordinated Reset Deep Brain Stimulation for Essential Tremor

This study is for people who have essential tremor and will be receiving the Boston Scientific Vercise Genus deep brain stimulation (DBS) system. We are studying the possibility that a kind of deep brain stimulation called "coordinated reset" stimulation (CR-DBS) will be more effective than current DBS treatment for essential tremor. We expect that participants will be in this research study for about 9 to 11 months.

Principal Investigator: Jing Wang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018050
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Essential Tremor (ET)
• age 21 or older
• will receive a Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
Exclusion Criteria:

• history of musculoskeletal disorders that affect movement of the limbs or gait
• history of dementia or cognitive impairment
• significant psychiatric disease
• on medication that could cause tremor
• women who are pregnant
• prior brain surgery
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), Essential Tremor, ET
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Vestibular and Cortical Contributions to Transitions in Freezing of Gait and Parkinson's Disease

This study will examine the brain activation associated with the transition between movements in Parkinson’s disease, and if these changes are related to the development of problems with moving (like freezing of gait) and thinking. We will look at brain activity associated with the vestibular (inner ear) and cortical (surface of the brain) systems. People with Parkinson’s disease (especially people with freezing of gait) sometimes have difficulty initiating changes in movement types, such as going from standing to walking, turning, or switching between slow and fast repetitive movements. The difficulty in movement transitions may be associated with an overactive vestibular system (inner ear) or cortical system. In each experiment in this study, we expect about 20-25 participants with Parkinson’s disease and freezing of gait, 20-25 participants with Parkinson’s without freezing of gait, and 20-25 control participants

Principal Investigator: Sommer Huffmaster
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022459
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 40 to 80 years old
• diagnosis of idiopathic PD with and without freezing gait
• able to walk independently without the use of an assistive device (e.g. cane) for 50 meters (about 160 feet)
• for HEALTHY OLDER ADULTS: 40 to 80 years old, able to walk independently without a cane or walker and able to perform complex activities of daily living independently
Exclusion Criteria:

• any musculoskeletal disorder that affects the ability to stand or walk
• history of musculoskeletal disorders that significantly affect movement of lower limbs
• uncorrected visual impairment
• history of visual and/or vestibular conditions
• moderate to severe hearing impairment
• women who are pregnant
• study staff will discuss additional exclusion criteria
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), freezing gait, Parkinson's disease
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Imaging Core Aim 2, and Udall Project 2 Aim 2

We are conducting this research to try to find a better way of treating Parkinson's disease, specifically postural instability and gait disturbances (PIGD) by looking at certain brain characteristics using 3T magnetic resonance imaging (MRI.) We think we could discover how to make DBS more effective for such things as postural gait instability and other symptoms of PD. Participants will be asked to come to our research location, walk on a treadmill, and have a 3T MRI.

Principal Investigator: Noam Harel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016989
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 21 years old
• already have a MRI-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson’s disease
• able to speak English
Exclusion Criteria:

• women who are pregnant
• extreme claustrophobia
• unable to have a MRI
Conditions: Brain & Nervous System
Keywords: DBS, Clinics and Surgery Center (CSC)
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Mechanisms and effects of pallidal deep brain stimulation on levodopa resistant motor signs in Parkinson's disease; Udall Project 2, Aim 2

We hope to identify patterns in the brain that may be related to symptoms of PD, such as problems with walking. We are also testing different stimulation settings to see if they might be more effective than the settings that are currently used for treatment. This research may aid in our understanding of PD and how to treat it more effectively with DBS.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016988
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• receiving DBS therapy in for treatment of Parkinson's Disease (PD)
• implanted with Medtronic Percept DBS system
• at least 3 months since initial activation of the DBS
Exclusion Criteria:

• musculoskeletal disorders that significantly affect the ability to perform the motor tasks
• dementia or cognitive impairment
• other significant neurological disorders
• post-operative complications or adverse effects of the DBS stimulation
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson Disease
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Sensory, cognitive, motor interactions

This study is about understanding how cognitive, sensory, and motor processes interact. Participants must be a stroke survivor, with a unilateral stroke, leaving arm weakness on one side only, that happened at least 3 months ago.

Principal Investigator: Shanie Jayasinghe
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025519
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18-80 years old
• had a stroke that happened more than 3 months ago
• have mild-to-moderate weakness on one side only
Exclusion Criteria:

• Non-English speakers
• women who are pregnant
• have a pacemaker
• had a bilateral stroke
Conditions: Brain & Nervous System
Keywords: stroke
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Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics: R33 Phase

This study will look at the effects of treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and Transcranial Magnetic Stimulation (TMS) for young people who have tic disorder. Participants must be 12- 21 years old and able to have an MRI. All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered to be the first treatment for tics. Participants will also be assigned randomly (by chance) to receive TMS or a sham (treatment not delivered) just before each CBIT session. The device for TMS delivers electromagnetic stimulation to a specific area of the brain with a small coil on the scalp. The effectiveness of the CBIT for the two groups, with and without the TMS, will be compared.

Principal Investigator: Christine Conelea
Age Group: 12 years to 21 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023755
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Sex: Male or Female
Age Group: 12 years to 21 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between the ages of 12 – 21
• currently experiencing chronic motor and/or vocal tics
• able to undergo MRI
• study staff will review additional exclusion criteria
Exclusion Criteria:

• currently receiving therapy focused on tics
• currently taking neuroleptic/antipsychotic medications
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: TMS, Tourette's syndrome, Vocal tics, CBIT, Motor tics, Tic Disorder
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Investigating EEG as a biomarker for tinnitus improvement after bimodal stimulation

This study is about understanding how TMS affects the balance between inhibitory and facilitatory processes in the motor cortex. The study includes an experimental device, specifically transcranial magnetic stimulation (TMS), electroencephalography (EEG), and electromyography (EMG). TMS is a non-invasive brain stimulation method to probe brain activity. EEG is used to record brain activity through electrodes placed on the head, while EMG measures muscle activity through sensors attached to the skin.

Principal Investigator: Peggy Nelson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00025649
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• People with Tinnitus: subjective tinnitus, have not started wearing hearing aids in the last 3 months, and don't have implanted electronic devices and willing to commit to 6 weeks of study
• Healthy Volunteers: have not started wearing hearing aids in the last 3 months and willing to commit to 6 weeks of study
Exclusion Criteria:

• People with objective tinnitus
Conditions: Brain & Nervous System
Keywords: Tinnitus
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Biorepository to Support ALS Research in Minnesota

The purpose of the study is to establish and maintain a biorepository of tissue and biospecimen samples relevant to Amyotrophic Lateral Sclerosis (ALS) research. We will obtain, store, and catalogue peripheral blood mononuclear cells (PBMCs), blood and blood components, skin punch biopsy samples, and cerebral spinal fluid (CSF) from people living with ALS, linked to clinical datasets, to advance ALS research.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022317
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• people living with ALS: people with a confirmed diagnosis of ALS
• Controls: people who have a neurological disorder other than ALS for which a comparison will assist in medical discovery Healthy controls: Individuals without ALS or other neurological disorders
Exclusion Criteria:

• age less than 18 or greater than 90
Conditions: Brain & Nervous System, Rare Diseases, Rare Diseases
Keywords: ALS, amyotrophic lateral sclerosis, Clinics and Surgery Center (CSC)
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Altered cortical representation of paretic leg muscles in individuals with stroke: a TMS-based motor mapping study

This research study is aimed at finding the changes in brain activity of people who have experienced a stroke and how it may affect their movement coordination during walking. Participants will be asked to walk on a treadmill at a comfortable speed while their movement pattern will be measured. Participants will also undergo magnetic resonance imaging (MRI) scan and assessment of the brain activity using Transcranial magnetic stimulation (TMS) which is a non-invasive brain stimulation method often used to stimulate nerve cells in the brain and assess connectivity between the brain and individual muscles.

Principal Investigator: Jacqueline Palmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024574
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18-85 years of age
• have either ischemic or hemorrhagic stroke at least six months ago
• had a single stroke or multiple strokes on the same side of the brain
• have residual paresis in the lower extremity
• can walk at least 10 feet with or without assistive device
• fluent in English
Exclusion Criteria:

• history of seizures
• take medications that could lower seizure thresholds
• history of brain injury or other CNS disease (with exception of stroke
• have a pacemaker or metal or electric implant in the head, neck, or chest area
• have non-MR compatible implants
Conditions: Brain & Nervous System
Keywords: Stroke
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Kinematic signatures of postural instability and gait in healthy adults

The purpose of this research is to better understand balance and walking in a healthy adult population to compare to patients with Parkinson’s Disease. This research study uses small wearable devices that attach to your clothing and can measure your body’s location while performing walking and balance tests. We expect that you will be in this research study at the Minnesota State Fair for approximately 10-15 minutes.

Principal Investigator: Robert McGovern, MD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00009709
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers

Exclusion Criteria:

• any neurological disease
• history of vertigo
• dementia of sufficient severity to impair the ability to make decisions
Conditions: Brain & Nervous System
Keywords: Balance, Movement, Parkinson's Disease, D2D
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Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals with Peripheral Neuropathy and Balance Problems &#8211; A Randomized Control Trial

The main purpose of this study is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. Walkasins have been developed to improve balance and walking by enhancing a person’s ability to feel the pressure beneath his/her feet as he/she walks.

Principal Investigator: Islam Zineldin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025212
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 55 years old
• able to complete all activities without the use of an assistive device
• diagnosis of peripheral neuropathy (if due to chemotherapy, must be 1 year after completion)
• experiencing problems with gait or balance
Exclusion Criteria:

• able to stand on one leg for at least 30 seconds
• acute thrombophlebitis, including deep vein thrombosis, or severe peripheral vascular disease
• lymphedema
• swelling, infection, inflamed area of skin or eruptions on the lower leg
• weigh more than 300 pounds
Conditions: Bone, Joint & Muscle, Brain & Nervous System
Keywords: Peripheral Neuropathies, Balance, Gait Disorders
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ACNS2321; A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas

This study aims to reduce the radiotherapy (RT) dose necessary to successfully treat patients with intracranial germ cell tumors who are in a state of complete response (CR) following chemotherapy. In this study, a further reduction in whole ventricular irradiation (WVI) will be tested. The primary aim of the study is to determine whether 12 Gy of WVI, and 12 Gy tumor boost, would be successful. Event-free survival (EFS) in patients with central nervous system germinoma, who meet criteria for CR or continued complete response (CCR) following chemotherapy/second-look surgery, would be the primary measurement of success.

Principal Investigator: Clay Hoerig
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024783
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patients must be ≥ 3 years and < 30 years at the time of study enrollment. Diagnosis:
• Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGβ 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required.
• Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus (DI) AND hCGβ ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required.
• Patients with hCGβ 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required.
• Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible.
• Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible.
• Patients with germinoma admixed with mature teratoma are eligible.
Exclusion Criteria:

• Patients with any of the following malignant pathological elements are not eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed GCT (i.e., may include some germinoma).
• Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible.
• Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible.
Conditions: Brain & Nervous System, Cancer, Children's Health
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Plasticity of motor systems in early stage Parkinson's disease

The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00008043
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:
Inclusion Criteria For PD Group:
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years
• Able to walk independently Inclusion Criteria For Control Subject Group: Age and sex matched to participants with PD and able to walk independently
Exclusion Criteria:
Exclusion criteria for PD group:
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnant women
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group: same as exclusion criteria of PD group
Conditions: Brain & Nervous System
Keywords: Parkinson
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Causal inference and impact of prior beliefs on perception

The study is being conducted in order to further understand how we perceive the world, and if and how this may be different in individuals on the autism spectrum. We hope to further understand sensory processing differences in autism.

Principal Investigator: Jean-Paul Noel
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00022626
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Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 14to 36 years old
• right-handed
• normal (or corrected) vision - normal hearing
• able to sit quietly and make judgments of sensory stimuli
• diagnosis of Autism
Exclusion Criteria:

• history of epilepsy
Conditions: Brain & Nervous System, Mental Health & Addiction, Vision & Eyes
Keywords: ASD, autism, decision-making, EEG, multisensory integration, perception, self-motion, sensation
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Neural Correlates of Pain and Alcohol Consumption in Chronic Temporomandibular Disorder (TMD)

The purpose of this research is to better understand how alcohol impacts pain processing in people with Temporomandibular Disorder (TMD) using MRI technology.

Principal Investigator: Jeff Boissoneault
Age Group: 18 years and over
IRB Number: STUDY00022066
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Age Group: 18 years and over
Inclusion Criteria:

• 21 years of age or older
• report regular drinking
• have a diagnosis of a Temporomandibular Disorders
Exclusion Criteria:

• diagnosis of Alcohol Use Disorder
Conditions: Brain & Nervous System, Dentistry, Mental Health & Addiction
Keywords: Alcohol, MRI, Orofacial Pain, Temporomandibular Disorders (TMD)
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SUSTAINED RELEASE ORAL FORMULATION FOR TREATMENT OF PARKINSON'S DISEASE

Medications used to treat Parkinson's disease will be delivered using a sachet ; placed in the oral/buccal cavity (between cheek and gum of lower jaw). This study may be a good fit for you if you are healthy, between the ages of 18 and 65, and aren’t currently taking regular medications. We expect that you will be in this research study for one visit, approximately 7 hours total. Compensation and transportation expenses will be provided.

Principal Investigator: Khalaf Bushara
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024501
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Normal healthy
• 18-65 years of age
• Not currently taking medications regularly
• Able to fast 6 hours, only water allowed
Conditions: Brain & Nervous System
Keywords: Healthy adults
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Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core

The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.

Principal Investigator: Scott Cooper
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1611M00822
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 21 years and older
• diagnosis of Parkinson's disease
• approved candidate for standard of care DBS surgery at the University of Minnesota
Exclusion Criteria:

• diagnosis of dementia
• women who are pregnant
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulation, Parkinson's Disease
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Neural Correlates of Goal Prioritization and Conscientiousness

This research will use neuroimaging to study the brain systems involved in prioritizing goals effectively, as well as testing whether variation in those systems is associated with the personality trait conscientiousness, which reflects organization, self-discipline, and industriousness and predicts important health and other life outcomes.

Principal Investigator: Colin DeYoung
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019311
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• age 20 - 50
• right handed
• no major psychiatric illness
Exclusion Criteria:

• claustrophobia
• any metal or devices in the body (e.g., pace makers, aneurysm clips etc.)
Conditions: Brain & Nervous System
Keywords: Brain imaging, Personality
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Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in at-risk Older Adults (The Exergames Telerehabilitation Study)

The purpose of this study is to test the effects of an in person or home-based exergame intervention on improving cognition and fitness in community-dwelling older adults with memory complaints. The exergame refers to a new low-cost virtual reality cognitive game with cycling. We expect that participants will be in this research study for 4 months. Intervention sessions will require approximately 1 hour, 3 days per week for 3 months.

Principal Investigator: Dereck Salisbury
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020635
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 65 years old
• experiencing a memory or cognitive problem
• speak English
• no physical problems that prevent exercise
Exclusion Criteria:

• diagnosis of dementia or mild cognitive impairment
• neurological or major psychiatric disorder, alcohol/chemical dependency or recent medical condition (anesthesia or COVID-19 brain fog) likely causing cognitive impairment
• currently enrolled in another clinical study
Conditions: Brain & Nervous System, Community Health
Keywords: cognitive, exercise, Memory
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Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People with Chronic Temporomandibular Disorder (TMD) Pain (TMD)

This study is about how pain affects drinking behaviors in people with chronic temporomandibular disorder (TMD).

Principal Investigator: Jeff Boissoneault
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023834
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 21+ years of age, with a valid ID
• Fluent in English
• Report drinking ≥ 2 days/week
• Women must report ≥1 drink/day on average over the last 6 months.
• Men must report ≥2 drink/day on average over the last 6 months
• Diagnosis of TMD, myalgia, TMJ, or a combination
• Have a smartphone with Internet
Exclusion Criteria:

• History of any psychotic disorder, current major depression, substance use disorder or current alcohol use disorder
• Serious medical illness
• Under-controlled hypertension or diabetes or neurological disease
• Impaired cognitive function
• Women who are pregnant breastfeeding, or intending to become pregnant
• Loss of sensation in lower legs or physical inability to complete study tasks
• Positive drug screening
• Medications that contraindicate alcohol use
• Comparison group: Chronic pain & TMD
Conditions: Bone, Joint & Muscle, Brain & Nervous System, Mental Health & Addiction
Keywords: Alcohol, Questionnaires, TMD/ TMJ, Virtual Reality
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