Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: A Randomized Control Trial (RCT) and an Open Label Extension Study (OLE).

Date Added
July 27th, 2021
PRO Number
Pro00111985
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

This study will help to determine if using an investigational neuromodulation headset device will help treat non-motor symptoms associated with Parkinson's disease (PD). The effectiveness of neuromodulation will help oral dopamine replacement therapies to improve (1) activities of daily living related to motor function, (2) motor symptoms and (3) quality of life for patients with PD. The headset will be worn for a total of 40 minutes per day (two 20 minute intervals). The study will take place over a year and will require a study partner to participate. This is a randomized controlled trial that randomizes participants into an intervention group or a control group (placebo). Participants will not know which treatment they are receiving. Questions about quality of life such as; depression, anxiety, PD symptoms, will also be asked.

Institution
MUSC
Recruitment Contact
Lisa Heidelberg
843-792-8327
heidelbe@musc.edu

Combined Deep Brain Stimulation and Functional Magnetic Resonance Imaging

Date Added
July 20th, 2021
PRO Number
Pro00111668
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Brain, Movement Disorders, Parkinsons
Summary

The purpose of this research study is to identify brain activation patterns in response to deep brain stimulation (DBS). To participate in this study, participants are required to have had a DBS implant or to be healthy controls without a history of a neurological disorder. Participants will undergo screening, a motor assessment session and a 30-minute Magnetic Resonance Imaging (MRI) session where their DBS device will be turned on and off in a cycled pattern. This study will be separated over 3 visits (Visit 1 for screening, Visit 2 for motor assessments and Visit 3 for the MRI scans). The total study duration will be approximately 5 hours.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

A double-blind, placebo-controlled, randomized, 18 month Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral UCB0599 in study participants with early Parkinson's Disease

Date Added
June 8th, 2021
PRO Number
Pro00109171
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

This study will help to determine if UCB0599 (study drug) can slow the progression of Parkinson's Disease (PD.) The study will look to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage PD.
Study participation will take place over 19 months (16 Visits) and will consist of in-clinic and remote visits. Participants will take UCB0599 orally, in pill form.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

Effect of Istradefylline (ISD) treatment on behavioral measures of apathy in Parkinson's disease (PD)

Date Added
May 25th, 2021
PRO Number
Pro00108116
Researcher
Travis Turner

List of Studies


Keywords
Parkinsons
Summary

Apathy is defined as a lack of feeling, emotion, interest, or concern. Apathy also involves reduction or loss of motivation and goal-directed behavior. Clinically significant apathy, where meaningful activities are given up and quality of life is diminished, is common in people with Parkinson's disease (PD).

Many individuals with Parkinson's disease experiencing fluctuations in the severity of their movement problems and medication "off" time. "Off" time refers to periods of the day between doses of PD medication when your motor symptoms (e.g., tremor, stiffness, slowness, walking problems, etc.) are worse and interfere with your ability to complete tasks of daily living. The investigational drug, Istradefylline, is an FDA-approved medication to treat motor fluctuations and "off" time in PD.

The purpose of this study is to investigate whether people with Parkinson's disease (PD) who are treated with istradefylline (ISD) show improvements in motivation and apathy over a 12-week period. Specifically, we wish to see whether people with PD who are treated with ISD engage in more physical and recreational activities, such as hobbies and other interests.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-0372
wilsosan@musc.edu

A mutlti-center, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subject with Parkinson's disease experiencing motor fluctuations (BouNDless)

Date Added
April 27th, 2021
PRO Number
Pro00108120
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Parkinsons
Summary

NeuroDerm Ltd. has begun a study of an investigational drug (also known as an experimental drug and is being studied to see if a disease or medical condition improves while taking it) called ND0612 as a possible treatment for Parkinson's disease. ND0612 is a solution of levodopa/carbidopa (LD/CD) delivered as a continuous subcutaneous (SC, meaning under the skin) infusion through a pump system to treat Parkinson's disease.

The study is divided into 6 periods. Those periods are as follows:
- Screening Period: 1-4 weeks
- Adjustment Period: 4-6 weeks
- Conversion Period: 4-6 weeks
- Maintenance Period: 12 weeks
- Open-Label Treatment Extension Period: 12 months
- Safety Follow-Up Period: 1-3 months

Subjects will need to come to the study center at least 8 times, and an additional 7 times if he/she participates in the treatment extension period; in addition to visits to the study center, some visits/activities will be performed over the phone.

The infusion pump is worn and administered via 2 infusion sites: abdomen or outer thigh, with locations being changed on a daily basis.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

Using task based fMRI to examine neural networks underlying gait in participants with Parkinson's Disease and Stroke

Date Added
January 19th, 2021
PRO Number
Pro00104950
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Healthy Volunteer Studies, Parkinsons
Summary

Parkinson's disease and stroke can cause lasting changes in walking and mobility. Non-invasive brain imaging methods including Magnetic Resonance Imaging (MRI) have been useful tools to understand the brains contribution to disrupted gait. In this study we are evaluating how activity in the brain in stroke and Parkinson participants changes when they are engaged in a gait-like behavior in the MRI scanner. We are seeking to recruit 10 participants with a diagnosis of PD, 10 participants with a history of stroke, and 10 age matched healthy control participants without a diagnosis of PD to undergo an hour of MRI scanning and an hour of gait assessments.

Institution
MUSC
Recruitment Contact
Sandra Wilson
2-4616
wilsosan@musc.edu

Clinical and laboratory studies to determine the causes of neurological disease in adults and children

Date Added
September 15th, 2020
PRO Number
Pro00102718
Researcher
Catherine Ziats

List of Studies

Keywords
Alzheimers, Autism, Dementia, Epilepsy, Mental Health, Multiple Sclerosis, Parkinsons
Summary

Neurological diseases are the leading cause of disability worldwide and a major contributor to health problems in children and adults. As the majority of these conditions result in lifelong disabilities, the implications for the family and for society is significant.

A significant number of adult and childhood neurological diseases have a genetic component and are caused by changes in our DNA and/or RNA leading to functional changes in the central nervous system. However, for many patients afflicted with these disorders, traditional genetic testing does not identify a clear genetic cause. The goal of this study will be to use newer genetic techniques to evaluate patients and families with neurological disorders to better understand the genetic basis of the disease.

Institution
Self Regional
Recruitment Contact
Catherine Ziats
8642507944
cziats@ggc.org

Effect of transcranial direct current stimulation on cortical oscillations during a virtual reality task

Date Added
August 20th, 2019
PRO Number
Pro00087153
Researcher
Nathan Rowland

List of Studies


Keywords
Brain, Parkinsons, Stroke, Stroke Recovery
Summary

Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with movement deficits, such as Parkinson's disease and chronic stroke. However, the effects of tDCS have so far not been proven on a wider scale due to lack of knowledge regarding exactly how tDCS works. This has limited the adoption of this potentially useful therapy for patients with Parkinson's disease, chronic stroke and other conditions affecting movement. We think that by studying the effect of tDCS on brain signals while subjects perform a virtual reality task that requires integration of visual and motor information we can separate out exactly what occurs in the brain when tDCS is turned on. We expect this approach to broaden our understanding of tDCS application in conditions affecting movement and possibly lead to therapeutic advances in this population.

Institution
MUSC
Recruitment Contact
Brenna Baker-Vogel
(843)792-0651
bakebren@musc.edu

RAD-PD: Registry for the Advancement of Deep Brain Stimulation in Parkinson's Disease

Date Added
August 1st, 2019
PRO Number
Pro00084846
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Parkinsons
Summary

This registry is designed for patients with Parkinson's Disease (PD) who are being considered for treatment with deep brain stimulation (DBS). A registry is a type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world.The purpose of the research is to create a list of patients with Parkinson Disease who are all receiving DBS to learn more about the effects of DBS on their PD symptoms

Institution
MUSC
Recruitment Contact
Tracy Millman
843-792-8311
millmant@musc.edu

Odor Disturbances: Clinical Care Registry

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde

List of Studies


Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu



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