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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to six treatment days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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