rTMS for Parkinson Disease
Phase-Based Progress Estimates
Effectiveness
Safety
University of Michigan, Ann Arbor, MI
Parkinson Disease
rTMS - DeviceEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
Parkinson disease (PD) is a common disorder in which reduced speed of movement results from inadequate brain production of the chemical dopamine. The most effective treatment for Parkinson disease is the use of drugs that provide dopamine replacement therapy (DRT). However, as the disease progresses there are prominent DRT-resistant features of Parkinson disease that are a major source of disability. These include cognitive (attention, memory) impairments and gait disorders such as freezing and falls. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, holds promise for the study and treatment of motor and cognitive deficits in persons with Parkinson's. To date, there are no conclusive results regarding an optimal rTMS protocol for recovery of motor and cognitive deficits in Parkinson's disease. This study is designed to promote clinical rehabilitation neuroscience research, and aims to improve rehabilitation in persons with Parkinson's with freezing of gait. This work will evaluate the use of a new accelerated, high dose, non-invasive brain stimulation method for treatment of freezing of gait in PD and will test how applying targeted accelerated stimulation to the brain improves gait disturbance due to PD.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 2 Secondary · Reporting Duration: Baseline; 48 hours post; 14 days post -intervention
Day 14
Percentage change in accuracy to precision force-tracking task at 48 hours and 14 days post-intervention
Baseline; 7-10 hours post-intervention
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
Week 1
Retention rate
Day 14
Net changes in FOG-Q scores at 48 hours and 14 days post-intervention
Percentage change in TUG test time to 48 hours and 14 days post-intervention
up to six treatment days
Participant perception of treatment acceptability
Trial Safety
Safety Progress
Side Effects for
Experiment 1: Parietal Cortex rTMS Stimulation - 4 Days
0%Migraine
0%Intolerance to stimulation
Trial Design
1 Treatment Group
Open label treatment
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: rTMS · No Placebo Group · N/A
Open label treatment
Device
Experimental Group · 1 Intervention: rTMS · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2008
Completed Phase 3
~730
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; 48 hours post; 14 days post -intervention
Closest Location: University of Michigan · Ann Arbor, MI
2022First Recorded Clinical Trial
17 TrialsResearching Parkinson Disease
1005 CompletedClinical Trials
Who is running the clinical trial?
University of MichiganLead Sponsor
1,597 Previous Clinical Trials
6,329,037 Total Patients Enrolled
19 Trials studying Parkinson Disease
1,458 Patients Enrolled for Parkinson Disease
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have Parkinson disease (PD) based on the recent Movement Disorder Society criteria.
You have Parkinson's disease (PD) and are >45 years old.
H&Y2-3 (early PD) subjects will be recruited.
You are a native English speaker.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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