Accelerated Brain Stimulation for Parkinson's Disease

Overseen By Ashley Rettmann

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

English speaker

My Parkinson's disease is in the early to mid-stage.

Able to provide written consent prior to admission

Exclusion Criteria

I have conditions that could increase my risk of seizures.

Cochlear hearing implants

Depression: Geriatric Depression Scale (GDS) score >11

Treatment Details

Interventions

• Function-based Accelerated Stimulation Therapy (FAST-therapy) (Non-invasive Brain Stimulation)

Trial Overview 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.

Participant Groups

Group I: Open label treatment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+