Transcutaneous auricular Vagal Nerve Stimulation (taVNS) in mild to moderate Parkinson's Disease Save

Date Added
March 20th, 2018
PRO Number
Pro00073767
Researcher
Vanessa Hinson

Silhouette
Keywords
Parkinsons
Summary

An investigator initiated pilot study of transcutaneous auricular vagal nerve stimulation (taVNS) in mild to moderate Parkinson's disease (PD).

We will assess whether nerve stimulation done on the surface of the skin, (called transcutaneous vagus nerve stimulation (taVNS)) is safe and effective in people with Parkinson's Disease (PD). A small electrical stimulator will be used to deliver electric pulses to a small portion of the left ear of the study participants. Participants will be assigned by chance to either 2 weeks of treatment with real taVNS, or a sham stimulation. The investigator will rate PD motor and cognitive symptoms before, during, and after the 2-week cycle. The investigators will also perform a number of blood and eye movement tests to check for the effectiveness of the stimulation, and perform regular safety checks.

Institution
MUSC
Recruitment Contact
Danielle Helms
843-792-8327
helmsda@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson's Disease (PD) Save

Date Added
December 19th, 2017
PRO Number
Pro00069638
Researcher
Vanessa Hinson

Silhouette
Keywords
Drug Studies, Movement Disorders, Parkinsons
Summary

The purpose of this study is to determine if a drug called Nilotinib is safe, if it can be tolerated by patients with PD and to learn if Nilotinib has the possibility of effectively treating PD symptoms. Nilotinib has been approved by the Food and Drug Administration (FDA) to treat certain types of cancer (leukemia) but is considered investigational in this study because it has not been approved for treating PD.

In this study, we are comparing two doses (150mg or 300mg) of Nilotinib to placebo (a pill that looks like the study drug but does not have any active medication in it, like a sugar pill). If you are eligible and choose to be in the study you will be randomly assigned to one of three groups, either:

? 150mg Nilotinib
or
? 300mg Nilotinib
or
? Placebo

All three groups will take two pills of the assigned type each day by mouth. ?Randomly' means that the group you are placed in is determined by chance (like tossing a coin). You will have a 2:1 chance of receiving Nilotinib. Neither you nor the researchers will know whether you are taking Nilotinib or placebo.

About 100 individuals will be interviewed and assessed, and 75 people will be asked to participate in this study at 25 clinics across the United States. Approximately 6 participants will be asked to participate in the study at MUSC.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson's Disease Patients Save

Date Added
November 28th, 2017
PRO Number
Pro00073013
Researcher
Christine Cooper

Silhouette
Keywords
Parkinsons
Summary

This study will assess the effectiveness, safety and tolerability of Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) compared to Immediate Release Carbidopa/Levodopa (IR CD/LD) (Sinemet) in patients with fluctuating Parkinson's disease (PD).

Institution
MUSC
Recruitment Contact
Danielle Helms
843-792-8327
helmsda@musc.edu

Validation of computer-based saccade and pupillary light reflex measures as biomarkers for progressive supranuclear palsy Save

Date Added
July 18th, 2017
PRO Number
Pro00065862
Researcher
Marian Dale

Silhouette
Keywords
Aging, Brain, Movement Disorders, Nervous System, Parkinsons, Rare Diseases, Vision/ Eye
Summary

This study examines eye movements and the pupil's response to light in progressive supranuclear palsy (PSP), comparing to Parkinson's disease and control subjects without neurological disease. Computerized measures of eye movements and pupil changes will be used. Subjects will also receive an eye exam to rule out other eye diseases. The goal of this study is to use subtle changes in eye movements and the pupil's response to light for earlier diagnosis of PSP.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

Brain Circuitry Changes in Vascular Parkinsonism Save

Date Added
July 6th, 2017
PRO Number
Pro00063429
Researcher
Christine Cooper

Silhouette
Keywords
Parkinsons, Vascular
Summary

This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.

Institution
MUSC
Recruitment Contact
Nancy Feracco
843-792-7859
feracco@musc.edu

Kickboxing and Cognition in Parkinson's Disease Save

Date Added
July 22nd, 2016
PRO Number
Pro00054295
Researcher
Vanessa Hinson

Silhouette
Keywords
Exercise, Memory Loss, Parkinsons
Summary

You are invited to volunteer for a research study if you have been diagnosed with Parkinson's Disease (PD) Stage 1-3.

This study will examine whether a kickboxing regime called "Rock Steady Boxing" helps improve cognitive dysfunction (thinking problems) in subjects with Parkinson's disease. "Rock Steady Boxing" is a fairly recent intervention for PD exercise rehabilitation.This program incorporates elements of aerobic exercise, with range of motion, visual spatial awareness, endurance, speed, agility, voice strengthening, and cognitive tasks. Your are eligible to participate if you plan to undergo Rock Steady Boxing as part of your own personal health plan, or you have indicated that you exercise regularly, but you do not intend to start Rock Steady Boxing.

Institution
MUSC
Recruitment Contact
Amy Delambo
843-792 5543
delambo@musc.edu

Dopamine agonists in the treatment of Parkinson's disease-associated depression: a naturalistic study Save

Date Added
March 28th, 2016
PRO Number
Pro00049718
Researcher
Fredy Revilla
Keywords
Parkinsons
Summary

This is a prospective, observational, naturalistic study to assess the efficacy of dopaminergic medications in reducing depressive symptoms, as measured by validated self-rating depression scales, and compared to initiation of alternative dopaminergic therapies (e.g. L-dopa vs. DA vs. MAO-B inhibitors).

Ascertainment of a true antidepressant effect of Pramipexole, Rotigotine and/or Ropirinole (or of any of the other dopaminergic agents) would have an impact on the manner in which this disabling problem is currently addressed.

In this study, we seek to collect data on the putative antidepressant and anti-apathy effect of dopaminergic medications (L-dopa and non-ergot DA, RPN, PPX, and rotigotine [RTG]), given under naturalistic conditions to address motor impairment (not mood disorders), on PD patients, as measured by validated depression and apathy rating scales, and comparing it to changes to L-dopa and other anti-parkinsonian agents.

Institution
Greenville
Recruitment Contact
Enrique Urrea Mendoza
864-454-5076
eurreamendoza@ghs.org

Determining Transcranial Direct Current Stimulation generated Intracerebral Electric Fields Save

Date Added
February 16th, 2016
PRO Number
Pro00052146
Researcher
Wuwei Feng

Silhouette
Keywords
Brain, Parkinsons
Summary

In this study, we plan to record electric fields (EF) in the brain while transcranial direct current stimulation (tDCS) is applied through the scalp. We will include patients who are scheduled to undergo deep brain stimulation (DBS) procedure to participate in the study, after explaining the procedures, answering any questions and receiving informed consent. The study might prolong the duration of the DBS procedure by a few minutes because of the time taken to apply tDCS. However, no other deviations from standard DBS procedures will be made. That is, no additional DBS electrode penetrations will be performed for research purposes - we will record from DBS electrodes that are being inserted exclusively as a part of clinical care.

Institution
MUSC
Recruitment Contact
Fay Davis
8437920883
davisfa@musc.edu

An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Save

Date Added
January 26th, 2016
PRO Number
Pro00048197
Researcher
Christine Cooper

Silhouette
Keywords
Movement Disorders, Parkinsons
Summary

This is a prospective, multi-center, open-label, Phase 3 study in Levodopa responsive PD patients with motor fluctuations, designed to evaluate the long-term safety, tolerability and efficacy of APL-130277. APL-130277 is being evaluated as a "rescue" treatment for OFF episodes.

The overall number of subjects is not pre-specified as this is an extension
study.

Patients who have completed any of the following studies: CTH-201,
CTH-203, CTH-300, CTH-301, or CTH-302 will be eligible to enroll into
this study. In addition, approximately one hundred (100) de novo patients
will also be enrolled.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-795-9115
jenkisho@musc.edu

Validation of a smart phone application to measure pupillary light reflex in untreated Parkinson patients and healthy adults Save

Date Added
July 23rd, 2015
PRO Number
Pro00044177
Researcher
Travis Turner

Silhouette
Keywords
Brain, Nervous System, Parkinsons
Summary

It is known that the pupil's response to light is abnormal in advanced Parkinson's disease. This study will explore whether signs of pupil dysfunction may be a biomarker of the presence of early Parkinson's disease (before medications are used to treat the condition.) The study will also examine a new and simplified way of measuring the pupil's response to light, using a smart phone application, to hopefully be used as a screening/tracking measure in clinical settings in the future. To complete this study, we are recruiting both healthy adults age 30-80 years old as well as individuals with early signs of Parkinson's disease that have not yet been treated with medication for this condition. The study required approximately 20-30 minutes to complete on MUSC's campus (compensation not included.)

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

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