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Non-invasive Brain Stimulation
Accelerated Brain Stimulation for Parkinson's Disease
N/A
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 48 hours post; 14 days post -intervention
Awards & highlights
Study Summary
This trial is testing a new, accelerated form of non-invasive brain stimulation to see if it can improve gait disturbance in people with Parkinson's disease.
Who is the study for?
This trial is for English-speaking Parkinson's disease patients aged 45-90, diagnosed based on Movement Disorder Society criteria and in the early stages (H&Y2-3). They must be able to consent. Excluded are those with other neurological diseases, depression (GDS score >11), brain lesions from imaging, implanted medical devices or metal in the head, conditions increasing seizure risk, or serious heart or liver diseases.Check my eligibility
What is being tested?
The study tests repetitive transcranial magnetic stimulation (rTMS) as a treatment for freezing of gait in Parkinson's patients. It explores an accelerated high-dose method of non-invasive brain stimulation to improve walking disturbances without relying on drug replacement therapy.See study design
What are the potential side effects?
Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness, tingling sensations or muscle contractions during treatment sessions. Rarely it could cause seizures or hearing loss if proper ear protection isn't used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to six treatment days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to six treatment days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Net changes in FOG-Q scores at 48 hours and 14 days post-intervention
Participant perception of treatment acceptability
Percentage change in TUG test time to 48 hours and 14 days post-intervention
+1 moreSecondary outcome measures
Changes in functional connectivity and BOLD signal in the basal ganglia-cerebellar-cortical network during resting state and task-based fMRI 7-10 days post-intervention
Percentage change in accuracy to precision force-tracking task at 48 hours and 14 days post-intervention
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open label treatmentExperimental Treatment1 Intervention
All subjects then will receive open-label treatment (Tx) for six days within an fourteen-day span (Visits 3-8). Briefly, a newer form of rTMS called intermittent theta burst stimulation (iTBS) will be used that mimics endogenous theta rhythms, which can improve induction of synaptic long-term potentiation and influence functional connectivity. A 10-min iTBS sessions will be applied to the basal ganglia-cerebellar-cortical network immediately after the subject has primed and activated the network by performing a precision force tracking task for up to 10 min. The subject will undergo 5 sessions of the force task and stimulation per day, with each session separated by 40 min.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2016
Completed Phase 3
~840
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,936 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have conditions that could increase my risk of seizures.My Parkinson's disease is in the early to mid-stage.I have been diagnosed with Parkinson's disease according to recent standards.I am between 45 and 90 years old with Parkinson's disease.I have a neurological condition or findings.I am either younger than 45 or older than 90 years old.I have been diagnosed with a serious neurological or systemic condition.I am taking medication that affects brain adaptability.
Research Study Groups:
This trial has the following groups:- Group 1: Open label treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to register for this clinical experiment?
"This clinical trial seeks 20 patients with Parkinson's disease, ranging in age from 45 to 90. To be eligible for participation, potential participants must meet the following conditions: have a PD diagnosis based on recent Movement Disorder Society criteria; possess English language proficiency; demonstrate H&Y2-3 (early PD) characteristics; and provide written consent before enrolling."
Answered by AI
Is there still space available for participants in this research trial?
"Unfortunately, the information on clinicaltrials.gov implies that participant recruitment for this particular trial has been concluded as it was last edited on August 19th 2022. However, there are still 487 medical trials seeking patients at present."
Answered by AI
Is eligibility for the trial restricted to adults aged 18 or older?
"This particular medical trial is searching for participants aged between 45 and 90. Those below the age of 18 can choose from 27 other clinical trials while those over 65 have 484 options to explore."
Answered by AI
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