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Search Results Within Category "Brain & Nervous System"

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55 Study Matches

Muscular Dystrophy Association Neuromuscular Observational Research (MOVR) Data Hub Protocol (#MDACS1)

Multi-Site Registry study

Peter Karachunski
Not specified
This study is NOT accepting healthy volunteers
SITE00000485
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Inclusion Criteria:
Any person who has a diagnosis of ALS, DMD, BMD, SMA, or any other neuromuscular diseases
Exclusion Criteria:
There are no exclusion criteria
Brain & Nervous System
Muscular Dystrophy, Neuromuscular diseases, Muscular Dystrophy Association (MDA)
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A longitudinal study of imaging biomarkers in amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS)

The purpose of the study is to test new biomarkers of amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS) using MRI scans at 3 tesla (3T). Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments.

David Walk
18 years and over
This study is NOT accepting healthy volunteers
1306M35941
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Inclusion Criteria:

• 21 to 75 years old
• diagnosis of possible, laboratory-supported probable, probable, or definite ALS or PLS
Exclusion Criteria:

• other neurodegenerative diseases (Parkinson disease, Alzheimer's disease, etc).
• inability to undergo MRI scanning
• needs assistance to walk or climb stairs
Brain & Nervous System, Rare Diseases
ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis
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See this study on ClinicalTrials.gov

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.

Michael Howell
18 years and over
This study is also accepting healthy volunteers
STUDY00019626
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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
Rare Diseases, Brain & Nervous System
dream enactment, Serotonergic REM sleep behavior
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HEALEY ALS Platform Trial

David Walk
18 years and over
This study is NOT accepting healthy volunteers
SITE00000881
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Inclusion Criteria:

• 18 years or older
• diagnosed with sporadic or familial ALS
• weakness started no more than 36 months ago -able to to swallow pills and liquids
Exclusion Criteria:

• unstable medical or mental health condition
• limitations on prior or current use of certain medications (study staff will review)
• women who are pregnant or breast feeding
Rare Diseases, Brain & Nervous System
Clinics and Surgery Center (CSC), ALS, amyotrophic lateral sclerosis
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See this study on ClinicalTrials.gov

Can spectral power and coherence reflect the integrity of the efferent cerebellar cortical pathway in cerebellar mutism syndrome?

This study will be measuring brain activity using EEG and assessing motor skills and speech in children following cancerous brain tumor resection. No direct cancer treatments or objectives are being targeted.

Sharyl Samagia-Grivette
Not specified
This study is also accepting healthy volunteers
STUDY00019602
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Inclusion Criteria:

• Cerebellar Mutism Syndrome (CMS) & Comparison (without CMS) Groups: ages 10 years 0 months to 25 years 11 months of age & fluent in English (parents/guardian do not need to be fluent in English)
• For those with Cerebellar Mutism Syndrome (CMS): history of resection of posterior fossa tumor at least 2 years before starting the study and at least 3 months post chemotherapy and radiation treatment
Exclusion Criteria:

• Comparison group without CMS: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder
• any genetic condition
• any neurologic condition including history of stroke, seizure disorder, or brain injury
• history of brain tumor or other cancer diagnosis
• CMS Group: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder prior to brain tumor diagnosis
• any genetic condition prior to brain tumor diagnosis
• any neurologic condition including history of stroke, seizure disorder, or brain injury disorder prior to brain tumor diagnosis
Brain & Nervous System, Cancer, Children's Health
brain tumor, cerebellar mutism syndrome (CMS)
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Transdiagnostic Cognitive Biomarkers

The overall objective of this study is to determine the feasibility of identifying transdiagnostic biomarkers of cognitive function mediated by neuromodulation of the dorsolateral prefrontal cortex that are translatable across disease groups in order to more accurately phenotype clusters of cognitive dysfunction. Completing behavioral paradigms with electrophysiology and TMS is a challenging frontier. This study focuses on the feasibility of such an endeavor for those with chronic pain or depression as well as healthy controls.

David Darrow
18 years and over
This study is also accepting healthy volunteers
STUDY00011759
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Inclusion Criteria:
Chronic refractory pain or depression:
• chronic pain that is not controlled with oral pain medications or
• diagnosis of major depression
• Healthy participants: adults at least 18 years old
Exclusion Criteria:
Contraindication to TMS:
• Metallic hardware in close contact to the discharging coil (such as cochlear implants, deep brain stimulator, medication pumps)
• History of seizures
• Epilepsy
• Contraindications to MRI
• Inability to complete tasks associated with study
• Pregnancy
• Pediatric participants
• Adult lacking ability to consent
• Non-English speaking
• Blindness Healthy Controls:
• diagnosis of chronic pain or depression
Mental Health & Addiction, Brain & Nervous System
MRI, Depression, Pain, imaging, brain, TMS, stimulation, fMRI
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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.

John Osborn Jr.
18 years and over
This study is NOT accepting healthy volunteers
SITE00002000
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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)
Brain & Nervous System, Mental Health & Addiction
Clinics and Surgery Center (CSC), Depression, Epilepsy, Vagal Nerve Stimulator, VNS
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Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics

This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.

Sonya Wang
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00020174
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Inclusion Criteria:

• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
Exclusion Criteria:

• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
Brain & Nervous System, Children's Health, Mental Health & Addiction
cbit, mental health, motor tic, tic, tourette syndrome, vocal tic
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See this study on ClinicalTrials.gov

STUDY OF PHIL EMBOLIC SYSTEM IN THE TREATMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS (PHIL dAVF)

Ramu Tummala
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003548
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Inclusion Criteria:

• 22 to 80 years old
• diagnosis of intracranial arteriovenous dural fistula (dAVF)
Exclusion Criteria:

• multiple dAVFs to be treated
• history of life threatening allergy to contrast media (unless treatment for allergy is tolerated)
• women who are pregnant
Brain & Nervous System
Arteriovenous Dural Fistula, dAVF
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teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior using Telehealth (Main Trial)

We are exploring ways to promote healthy lifestyles during stroke rehabilitation using a web-based rehabilitation program. The purpose of this study is to compare two intervention approaches: teleABLE and Healthy Lifestyles Education. Both interventions are delivered using video visits, so participants can complete all study activities from home

Emily Kringle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021288
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Inclusion Criteria:

• at least 18 years old
• diagnosed with stroke more than 6 months ago
• report 6 or more hours of sedentary behavior on a typical day
• live in a community-based setting (i.e., personal residence, assisted living facility)
• mobile within the home, with or without an assistive device and without physical assistance
Exclusion Criteria:

• Stroke and caregiver participants will be excluded if:
• currently receiving chemotherapy or radiation treatments for cancer
• have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinsons disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
• received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
• have a history of skin sensitivity related to adhesives
• pregnant or expecting to become pregnant in the next 2 months
• live in an institutional setting
• currently incarcerated
• stroke participants will also be excluded if they have severe aphasia
Brain & Nervous System
caregiver, CVA, physical therapy, rehabilitation, remote, Stroke, virtual
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Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

The purpose of this research study is to test the efficacy of the study drug, Brivaracetam, to reduce nerve pain in SCI. We also want to determine whether Brivaracetam impacts mood, brain, and genes to help us design more research with this study drug in the future. We will assign you randomly to one of 2 groups: the group that receives the active study drug (Brivaracetam) or the group that receives a placebo (sugar pill). There is a 50-50 chance that you will be assigned to one group or the other, similar to flipping a coin. Participation in this study will last approximately 11 weeks and will include 3 study visits to the study site; however, participation in the study can also be entirely virtual which would require no visits to the study site.

Ricardo Battaglino
18 years and over
This study is NOT accepting healthy volunteers
SITE00001486
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Inclusion Criteria:

• spinal cord injury occurred at least 3 months earlier
• completed inpatient rehabilitation and living in the community
• experiencing chronic neuropathic pain for three months or more
• for people of child-bearing potential: currently practicing an effective form of two types of birth control
Exclusion Criteria:

• progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
• brain injury or cognitive impairment limiting the ability to follow directions
• women who are pregnant or breastfeeding
• medical and mental health diagnosis that may interfere with study drug (study staff will review)
Brain & Nervous System
Neuropathic Pain, Spinal Cord Injuries
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See this study on ClinicalTrials.gov

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.

Jerrold Vitek
Not specified
This study is NOT accepting healthy volunteers
STUDY00019735
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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)
Brain & Nervous System
DBS, Dystonia, Essential Tremor, ET, Movement Disorders, Parkinson's, Parkinson's Disease, PD
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See this study on ClinicalTrials.gov

Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
1608M93561
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Inclusion Criteria:

• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
Exclusion Criteria:

• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson's Disease, PD
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Circuit-Based Deep Brain Stimulation for Parkinsons disease; Udall Project 1 Aim 2 and 3

Study objectives: -To characterize spontaneous and movement-related LFP changes in STN and GP in externalized patients under conditions that modulates the severity of tremor, bradykinesia and rigidity (off meds/off stim; on meds/off stim; off meds/on stim, on meds/on stim). -To characterize and compare the relative effect of different forms of closed loop stimulation (e.g., triggered at specific thresholds of low beta/HFO PAC or beta band activity) to standard isochronal high frequency DBS on motor signs and performance during movement.

Michael Park
18 years and over
This study is NOT accepting healthy volunteers
1701M04144
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Inclusion Criteria:

• diagnosis of idiopathic Parkinson's Disease
• DBS surgery or battery replacement at UMN is planned as part of routine clinical care
Exclusion Criteria:

• other significant neurological disorder
• history of dementia
• history of stereotactic neurosurgery
• people who have post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety
• women who are pregnant
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulation, Parkinson's Disease
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NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.

Elizabeth Neil
18 years and over
This study is NOT accepting healthy volunteers
MMCORC043
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Inclusion Criteria:

• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
Exclusion Criteria:

• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
Brain & Nervous System, Cancer
Brain Cancer, Brain Cancer, Glioblastoma
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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

1.1 Purpose: This protocol will carry out Aim 2 (Experiments 1 and 3) of Udall Project 2, leveraging the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over 4 weeks).

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016988
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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
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson Disease
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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.

Scott Cooper
18 years and over
This study is NOT accepting healthy volunteers
1611M00822
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Inclusion Criteria:

• age 21 years and older
• diagnosis of Parkinson's disease
• candidate for DBS
Exclusion Criteria:

• diagnosis of dementia
• women who are pregnant
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulation, Parkinson's Disease
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Robotic Gait Training to Improve Functional Outcomes after SCI

We are researching the benefits of physical therapy guided exoskeleton gait training in people with a spinal cord injury. We want to describe the benefits to overall function and how the brain changes after gait training.

Leslie Morse
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018674
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Inclusion Criteria:

• spinal cord injury level C7-T12
• medically stable, no acute issues that would prevent gaiting
• motor complete (AIS A or B) spinal cord injury OR motor incomplete (AIS C or D) spinal cord injury who use a wheelchair for more than 50% of personal mobility
• height between 155-191cm (5'1" to 6'2")
• weight less than 113kg (248 pounds)
• sufficient upper body strength to complete sit-to-sit transfers
• women of childbearing age must agree to use contraception during study participation
Exclusion Criteria:

• women who are pregnant
• symptomatic orthostatic hypotension
• active Grade 2 or greater pressure ulcer that can be potentially worsened by use of an exoskeleton
• lower extremity contractures that interfere with wearing an exoskeleton
• unhealed lower extremity fracture
• history of neurologic diseases (e.g. stroke, peripheral neuropathy, myopathy)
• active treatment for epilepsy or thyroid disorders
• women with osteoporosis at baseline by DXA scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Spinal Cord Injury (SCI)
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Ankle Position Sense Acuity in People with Parkinson's Disease Experiencing Freezing of Gait and Its Relationship to Gait

This study aims to investigate whether there is difference in ankle position sense acuity between people with Parkinson's with freezing of gait and without freezing of gait. It also examines the relationship between position sense acuity and severity of freezing of gait, and gait measurements.

Juergen Konczak
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019098
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Inclusion Criteria:

• 50 to 80 years old
• diagnosis of idiopathic Parkinsons Disease (PD) as determined by a movement disorder neurologist
• PD severity is mild to moderate
Exclusion Criteria:

• significant central or peripheral nervous system disease
• previous exposure to chemotherapy
• history of lower limb surgery or lower limb fractures within the last 6 months
• amputation or joint replacement of any part of the leg
• implanted deep brain stimulation or other neurosurgery to treat PD
• additional medical factors (study team will review)
Bone, Joint & Muscle, Brain & Nervous System
Parkinson's, Parkinson's Disease
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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3 (SPARX3)

The purpose of this study is to compare the effects of 2 different levels of exercise intensity and to learn more about effects of aerobic exercise for people with Parkinson’s disease (PD). This study will help us better understand what exercise guidelines should be used in the future.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
SITE00001163
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Inclusion Criteria:

• 40 to 80 years old
• diagnosis of idiopathic Parkinson Disease (PD)
• less than 3 years since disease diagnosis
Exclusion Criteria:

• currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics
• expected to start medication within six months of starting the study
• previous use of medications for PD for more than 60 days
• exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months
• known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program
• uncontrolled hypertension (resting blood pressure greater than 150/90 mmHg)
• any medical, mental health, drug or alcohol abuse, assessment or laboratory abnormality that indicates a problem that could limit ability to participate in the exercise program (study staff will evaluate)
• women who are breast-feeding, pregnant, or plan to become pregnant in the next 12 months
• unable to have a brain scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Parkinson Disease, Parkinson's Disease
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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors
for Stroke Prevention and Recovery (ASPIRE)

This study will compare the effects of apixaban to aspirin in patients who have atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Oladi Bentho
18 years and over
This study is NOT accepting healthy volunteers
SITE00000694
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Inclusion Criteria:

• diagnosis of Intracerebral hemorrhage (ICH) confirmed by brain CT or MRI
• documented atrial fibrillation or atrial flutter
• can enter study 14 to 180 days after ICH
• women willing to use highly effective birth control
Exclusion Criteria:

• prior ICH within last 12 months
• women who are pregnant or breast feeding
• allergy to aspirin or apixaban
• persistent, uncontrolled systolic blood pressure (?180 mm Hg)
• contact study staff for additional exclusion criteria
Brain & Nervous System, Heart & Vascular
Anticoagulation, Atrial Fibrillation (AF), CVA, ICH, Intracerebral Hemorrhage, Stroke
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Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)

This study is about a genetic condition called Adrenoleukodystrophy (ALD). The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in medical care and monitoring. This is important to identify the optimal ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future. We will also have healthy comparisons to help to learn more about the condition (ALD) being studied, by comparing the information collected to a child without the condition.

Rene Pierpont
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00016246
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Inclusion Criteria:

• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
Exclusion Criteria:

• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
Brain & Nervous System, Children's Health, Rare Diseases
Healthy control, children, pediatrics, adolescents
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Genetics of Developmental Disorders - Data and Specimen Repository

This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.

Williams Dobyns
Not specified
This study is NOT accepting healthy volunteers
STUDY00011194
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Inclusion Criteria:

• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Brain & Nervous System, Rare Diseases, Children's Health
Genetic disorders, developmental brain disorders, developmental disorders
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duoABLE: Feasibility of a Behavioral Activation-Based Intervention to Reduce Sedentary Behavior Among People with Stroke and their Caregivers

We are exploring ways to help people with stroke and their caregivers be more physically active in their daily lives. The purpose of this study is to determine whether delivering the web-based Activating Behavior for Lasting Engagement (ABLE) program to duos is a feasible and acceptable approach.

Emily Kringle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018984
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Inclusion Criteria:

• at least 18 years old
• diagnosed with stroke more than 6 months ago
• report 6 or more hours of sedentary behavior on a typical day
• live in a community-based setting (i.e., personal residence, assisted living facility)
• mobile within the home, with or without an assistive device and without physical assistance
• able to identify an eligible caregiver who will participate in the study who also: reports 6 or more hours of sedentary behavior on a typical day, lives in a community setting and mobile within their home, (with or without an assistive device and without physical assistance)
Exclusion Criteria:

• Stroke and caregiver participants will be excluded if:
• currently receiving chemotherapy or radiation treatments for cancer
• have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinsons disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
• received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
• have a history of skin sensitivity related to adhesives
• pregnant or expecting to become pregnant in the next 2 months
• live in an institutional setting
• currently incarcerated
• stroke participants will also be excluded if they have severe aphasia
Brain & Nervous System
CVA, Stroke, caregiver, physical therapy, rehabilitation, remote, virtual
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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

Manda Keller-Ross
18 years and over
This study is also accepting healthy volunteers
STUDY00013742
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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
Blood Disorders, Brain & Nervous System, Women's Health
autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats
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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.

Luke Johnson
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018981
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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
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Parkinson's Disease, Sleep Apnea
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Neuroplasticity in REM Sleep Behavior Disorder

REM sleep behavior disorder may predict the eventual symptom development of Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy. This occurs over years to decades and the sleep disorder may hide other typical symptoms and result in a delay in diagnosis. We are studying the changes in the brain over two years. We will do high field MRI’s (7T) and other tests of neurological function of people who have REM sleep disorder and people who don’t have this disorder (matched for age and sex).

Colum MacKinnon
18 years and over
This study is also accepting healthy volunteers
STUDY00016232
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Inclusion Criteria:

• Diagnosis of isolated iRBD confirmed by sleep study
• Able to walk independently without the use of an assistive device (e.g., cane) for at least 50 meters.
• 21 to 75 years old
Exclusion Criteria:

• Diagnosis of Dementia
• History of musculoskeletal disorders that significant affect movement of lower or upper limbs
• Other significant neurological disorders
• Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.
• Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).
• Untreated sleep-disordered breathing
• Pregnant women
Brain & Nervous System
Idiopathic REM sleep Behavior Disorder, iRBD, Sleep Disorder
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Fully Automated Motion-corrected MR Spectroscopy in Human Brain and Spinal Cord

The goal of this proposal is to develop fully automated, high performance, motion-corrected MRS sequences for the brain and spinal cord, that are also easy to share (no additional external hardware needed) with other institutions and easy to use.

Dinesh Deelchand
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00009397
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Inclusion Criteria:
We are looking for healthy children volunteers who are: Do not have a history of neurological disorder (stroke, brain, or C-spine injury, etc., and are 6 years of age or older at time of screening.
Exclusion Criteria:

• Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
• Pregnancy
• Claustrophobia
• Inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Diabetes that has been diagnosed within the past 3 months (diabetes is OK if it is stably controlled (per participant report of either HbA1c <7.0 or stable control for at least 3 months))
• Hearing loss sufficient to prevent communication via telephone
• Weight > 250 and BMI > 35.
• Uncontrolled high blood pressure (>170/100) or working with doctor to stabilize blood pressure
• Severe lung, liver, kidney or heart disease of other major organ failure.
• Head size > 23.25 inches
Brain & Nervous System
MRI, MRS
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Neural mechanisms of early visual dysfunction in psychosis

The purpose of this study is to look at symptoms, thoughts, and behaviors related to the way a person sees the world. This is called visual perception. This study will also look at brain function. We will study these things in people with and without psychosis. People with psychosis see the world differently than others. For example, they may experience hallucinations. We are interested in understanding how differences in the way people see the world relate to brain circuits. This project will use visual and behavioral experiments, EEG, and Magnetic Resonance Imaging (MRI) to look at how visual perception is different in people with and without psychosis. This research study has three visits lasting 2-4 hours each. We expect that these visits will take place over 2-3 months, depending on your availability and preferences.

Michael-Paul Schallmo
18 years and over
This study is also accepting healthy volunteers
STUDY00007958
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Inclusion Criteria:

• 18-60 years old
• normal or corrected-to-normal vision
• current diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:

• claustrophobia
• current substance dependence (other than nicotine)
• any vision problem (e.g. strabismus/crossed eyes, lazy eye, color blindness)
• current or past diagnosis of bipolar I disorder
Brain & Nervous System, Vision & Eyes
EEG, MRI, neuroscience, psychosis, vision
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teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) (teleABLE)

We are exploring ways to increase physical activity after stroke using a web-based rehabilitation program. The purpose of this study is to adapt the Activating Behavior for Lasting Engagement (ABLE) program using video visits so people with stroke can participate from home.

Emily Kringle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018044
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Inclusion Criteria:

• experienced a stroke in the last 12 months
• currently spend at least 6 hours per day sitting
• access to a device for virtual video visits
Brain & Nervous System, Heart & Vascular, Prevention & Wellness
dwell, exercise, occupational therapy, physical therapy, remote, stroke rehab, teleable, virtual
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See this study on ClinicalTrials.gov