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Search Results Within Category "Brain & Nervous System"

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56 Study Matches

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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Genetics of Developmental Disorders - Data and Specimen Repository (Le-Na)

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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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.

Noam Harel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016989
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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
Brain & Nervous System
DBS
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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.

Christopher Moertel, MD
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00022372
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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
Brain & Nervous System
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Optimization of deep brain stimulation parameters in patients with medically refractory epilepsy

The purpose of this research is to better understand how deep brain stimulation settings can affect the electrical activity in the brain and the frequency of seizures. There are a number of different ways in which the deep brain stimulation electrodes can be programmed to stimulate the brain. This research study uses the implanted battery in the chest to record electrical activity from the brain at different stimulation settings. We then use this electrical activity to determine stimulation settings that are “personalized” to your brain.

Robert McGovern, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011863
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Inclusion Criteria:
People who have medically refractory epilepsy with a deep brain stimulator in place
Exclusion Criteria:
People who have dementia of sufficient severity to impair their ability to make healthcare related decisions for themselves
Brain & Nervous System
Epilepsy, DBS, Deep Brain Stimulation
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Multicenter ALS Imaging Study

The purpose of the study is to test new biomarkers of ALS using MRI scans at 3 Tesla (3T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers in ALS will help test new treatments and may help us make diagnoses earlier.

Pramod Pisharady
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021637
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Inclusion Criteria:

• for people who have Amyotrophic Lateral Sclerosis (ALS): less than 24 months since symptoms started, and diagnosis of probable or definite ALS
• for people with ALS and healthy volunteers: able to read, write and speak English, and able to have a MRI
Exclusion Criteria:

• any condition that makes MRI unsafe or if unable to comply with instructions
• healthy volunteers with clinically significant abnormal findings on neurological examination
Brain & Nervous System, Rare Diseases
ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis
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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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Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD (NExT)

We are doing this study to see if we can improve the standard treatment for OCD, Exposure with Response Prevention, by pairing it with Transcranial Magnetic Stimulation to the parts of the brain that cause OCD symptoms.

Christine Conelea
Not specified
This study is NOT accepting healthy volunteers
STUDY00020646
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Inclusion Criteria:

• 12 to 21 years old
• right-handed
• currently have OCD symptoms
Exclusion Criteria:

• inability to have a MRI
• left-handed
• study staff will review additional exclusion criteria
Brain & Nervous System, Children's Health, Mental Health & Addiction
Obsessive-compulsive disorder, OCD, psychology, therapy, TMS, transcranial magnetic stimulation
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See this study on ClinicalTrials.gov

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.

Robert McGovern, MD
18 years and over
This study is also accepting healthy volunteers
STUDY00009709
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Exclusion Criteria:

• any neurological disease
• history of vertigo
• dementia of sufficient severity to impair the ability to make decisions
Brain & Nervous System
Balance, Movement, Parkinson's Disease, D2D
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mGlide-Care: A mHealth Partnership with caregivers to improve HTN management in patients with cognitive impairment

The purpose of this study is to learn about a new way of managing hypertension using a wireless blood pressure monitor and a smartphone. The goal is to improve hypertension care in older adults with memory loss or mild dementia in partnership with their caregiver.

Kamakshi Lakshminarayan
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018765
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Inclusion Criteria:

• adults ages 60-85 years
• diagnosis of hypertension
• diagnosis of mild cognitive impairment or early stage Alzheimer's Disease/Related Dementias
• participant has an unpaid family caregiver
Exclusion Criteria:

• severe comorbid illness including end-stage kidney disease, end-stage liver disease,
• participant and caregiver unable to complete study tasks or have plans to relocate in the next 12 months
• serious psychiatric illness that could interfere with treatment, assessment, or compliance
Brain & Nervous System, Community Health, Heart & Vascular
blood pressure, caregiving, dementia, Hypertension, memory, Mild cognitive impairment
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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.

Lindsey Sloan
Not specified
This study is NOT accepting healthy volunteers
SITE00000958
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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
Brain & Nervous System, Cancer
Brain Tumor
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A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.

The purpose of this research study is to compare surgical tumor removal followed by stereotactic radiotherapy (SRT) to surgical tumor removal followed by radiation therapy delivered by surgically implanted GammaTilesTM (GT). A GammaTile (GT) is an FDA cleared device used to provide radiation therapy following the removal of a brain tumor. GT are small (2cm x 2cm x 0.4cm) collagen squares/tiles that contain sources of radiation that look like grains of rice. If assigned to the GT study group, the doctor will place tiles containing the radiation sources in the cavity left after surgically removing the brain tumor. They do not need to be removed as the collagen tiles will be absorbed and the radiation sources can be left in place. If assigned to the SRT study group, SRT will take place 3-4 weeks after surgery and uses external beams to deliver radiation to the cavity left after surgically removing the brain tumor.

Lindsey Sloan
18 years and over
This study is NOT accepting healthy volunteers
SITE00001150
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Inclusion Criteria:

• one to four newly diagnosed brain metastases, from an extracranial primary tumor (found on MRI)
• planned surgery to remove one lesion is between 2.5 cm and 5.0 cm in size, other lesions must be less than 4.0 cm in size
• able to complete an MRI of the head with contrast
• fluent in English or Spanish language
• additional criteria apply, contact study staff
Exclusion Criteria:

• past radiation or surgical therapy newly diagnosed lesion(s)
• more than 4 newly diagnosed metastases on MRI
• psychiatric, neurologic disease, injury impacting cognition
Brain & Nervous System, Cancer
Brain Cancer, Clinics and Surgery Center (CSC)
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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.

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

HEALEY ALS Platform Trial

The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. We are doing this research to find out if different treatments have an effect on Amyotrophic Lateral Sclerosis (ALS). We also want to find out if these treatments are safe to take without causing too many side effects.

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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Quantifying the Individual Heterogeneity of Presentation and Symptoms of Cognitive Impairment in Long COVID

This questionnaire and cognitive task study is being done to learn how different activities, like exercise, sleep, and stress, may affect symptoms of long COVID. We also want to know how symptoms may fluctuate over different times during the day and over several weeks. The study will take about 4 weeks to complete and will be done remotely.

Kelvin Lim
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017662
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Inclusion Criteria:

• able to speak English
• have access to a compute with internet access
• history of having COVID-19
• continue to experience symptoms of long COVID-19 such as fatigue, "brain fog", trouble sleeping, headaches, etc.
Exclusion Criteria:

• never tested positive for COVID-19
Brain & Nervous System, COVID-19
brain fog, COVID-19, fatigue, Long COVID-19
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Brain Mechanisms of Qigong for Neuropathic Pain Relief in Adults with Spinal Cord Injury

The researchers aim to prove that Qigong practice can result in reduced or relieved neuropathic pain, improved mood, life satisfaction, self-efficacy, enjoyment to move, and community integration; and decreased fear of movement, use of medication or health care services for adults with spinal cord injury.

Ann Van de Winckel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011997
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Inclusion Criteria:

• 18 to 75 years old
• spinal cord injury (SCI) at least 3 months ago
• medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
• highest level of below-level SCI-related neuropathic pain >3 on the numeric pain rating scale.
Exclusion Criteria:

• unable to have a MRI (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder; cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent the participant from following directions or from learning
• ventilator dependent
• pregnant or plans to become pregnant during study
• inability to perform kinesthetic imagery
Brain & Nervous System
SCI, Spinal Cord Injury
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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.

Dereck Salisbury
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020635
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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
Brain & Nervous System, Community Health
cognitive, exercise, Memory
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Humanitarian Use Device: Medtronic DBS Therapy for Dystonia (HDE #H020007) (Dystonia IRB)

Humanitarian use devices are medical devices approved by the FDA for the treatment of medical conditions affecting fewer than 4,000 patients per year. The FDA reviewed the safety of the device and determined that the probable health benefits outweigh the risks of injury or illness from its use. Effective treatment of symptoms, however, has not been studied in formal clinical trials. Medtronic DBS Therapy delivers electrical stimulation to areas in the brain to help control symptoms of various movement disorders. You may be a candidate for Medtronic DBS Therapy for Dystonia if you have been diagnosed with chronic, intractable (drug refractory) primary dystonia. You or your third party payer (health insurance, Medicare, Medicaid or other) must provide payment for hospital, office and other medical costs related to this therapy.

Jerrold Vitek
7 years and over
This study is NOT accepting healthy volunteers
1207M17701
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Inclusion Criteria:

• 7 to 99 years old
• diagnosed with chronic, intractable (drug refractory) primary dystonia determined by a neurologist or neurosurgeon
Exclusion Criteria:

• patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist
• patients who have not had an adequate trial of medical or non-surgical treatment
Brain & Nervous System
DBS, Deep Brain Stimulation, Dystonia
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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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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.

Jing Wang
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018050
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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
Brain & Nervous System
Essential Tremor, ET
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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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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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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 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, physical therapy, rehabilitation, remote, Stroke, virtual
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NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2

We are recruiting only healthy participants who do not have REM sleep behavior disorder. The information gained from this study will help the investigators understand more about REM sleep behavior disorder (RBD), and the possible underlying neurologic disorders that can cause RBD.

Michael Howell
18 years and over
This study is also accepting healthy volunteers
SITE00001442
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Inclusion Criteria:

• male
• 54 to 75 years old
• Caucasian
Exclusion Criteria:

• history of dream enactment
• diagnosis of Parkinson's Disease, dementia, MCI, or MSA
• blood relative with REM Sleep Behavior Disorder
Brain & Nervous System, Breathing, Lung & Sleep Health
Clinics and Surgery Center (CSC), control, neurology, Parkinson's Disease, REM Sleep Behavior Disorder, sleep, RBD
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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.

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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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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See this study on ClinicalTrials.gov

Kinematic signatures of postural instability and gait in Parkinson Disease

The purpose of this research is to better understand balance and walking in patients with Parkinson’s Disease. This research study uses small wearable devices that attach to clothing and can measure the body’s location while performing walking and balance tests.

Robert McGovern, MD
18 years and over
This study is also accepting healthy volunteers
STUDY00005877
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Inclusion Criteria:

• People diagnosed with Parkinson's disease, with or without implanted Deep Brain Stimulator (DBS). May be at any age of disease progression.
• Healthy adults of similar age to participants who have Parkinson's Disease and are enrolled in the study.
Exclusion Criteria:
People who have dementia of sufficient severity to impair their ability to make health-care decisions for themselvess
Brain & Nervous System
Parkinson's, Parkinson's Disease, Deep Brain Stimulator, DBS
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Causal Modeling of Ecological Momentary Assessment and Wearable Data in Youth

Researchers want to find out more about how physical, cognitive, and emotional factors affect eating.

Amy Gross
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00021073
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Inclusion Criteria:

• 13-17 years old
• BMI at least at the 95th percentile
• own a smartphone and are willing to wear a Garmin (we provide), download the Garmin Connect App on their smartphone and authorize Garmin to transfer study data study staff
Exclusion Criteria:

• medication changes in the last 28 days for medications that are likely to affect appetite, mood, and attention
Brain & Nervous System, Children's Health
adolescents, Eating behaviors
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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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See this study on ClinicalTrials.gov

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

The Muscular Dystrophy Association (MDA) wants to collect information about individuals with neuromuscular disease to better understand the disease progression and ultimately improve the medical care, quality of life, and survival of those with neuromuscular disease. To collect this information, MDA has created a data registry called the Neuromuscular Observational Research Data Hub (referred to as the “MOVR Data Hub”).

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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