Accelerated Brain Stimulation for Parkinson's Disease

Overseen By Michael Vesia, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Dopamine replacement

Must not be taking: GABAergic, NDMA-receptor antagonist

Disqualifiers: Neurologic disease, Depression, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment method to assist people with Parkinson's disease who struggle with freezing of gait, which can hinder walking and lead to falls. The treatment, Function-based Accelerated Stimulation Therapy (FAST-therapy), uses a non-invasive brain stimulation technique called rTMS. This technique aims to enhance movement and memory by stimulating specific brain areas. The trial seeks participants diagnosed with Parkinson's disease who experience walking difficulties.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for those with Parkinson's disease.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications that affect brain receptors, like GABAergic drugs or NDMA-receptor antagonists. If you're on these, you might need to stop them to participate.

What prior data suggests that this brain stimulation method is safe for treating Parkinson's disease?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe. This non-invasive brain treatment has improved symptoms in Parkinson's disease. A specific type of rTMS, called intermittent theta-burst stimulation (iTBS), has been studied for its effects on daily function and quality of life in Parkinson's patients.

Studies indicate that iTBS usually doesn't cause serious side effects. Most people experience only mild discomfort, such as a slight headache or scalp irritation, which resolves quickly. Available studies have reported no long-term negative effects from these treatments.

This method is not yet approved for widespread use, but ongoing research aims to confirm its safety and effectiveness. As a non-invasive treatment, it is considered to have a lower risk than many other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Parkinson's disease focus on managing symptoms using medications like Levodopa or dopamine agonists. However, Function-based Accelerated Stimulation Therapy (FAST-therapy) offers something different. It uses a cutting-edge technique called intermittent theta burst stimulation (iTBS), which mimics natural brain rhythms to enhance brain connectivity and synaptic strength. Researchers are excited because this method directly targets the brain's networks involved in movement, potentially offering quicker and more efficient symptom relief than traditional treatments.

What evidence suggests that this accelerated brain stimulation is effective for Parkinson's disease?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), particularly intermittent theta burst stimulation (iTBS), may help alleviate symptoms of Parkinson's disease. iTBS can enhance movement and improve overall quality of life for patients. Studies have found that specific applications of this treatment can significantly reduce motor symptoms like freezing of gait, common in Parkinson's. Early results suggest that targeting iTBS to brain areas controlling movement can noticeably relieve symptoms. This method mimics natural brain rhythms, aiding the brain in better movement control. Participants in this trial will receive Function-based Accelerated Stimulation Therapy (FAST-therapy), which uses iTBS, to assess its effectiveness in treating Parkinson's disease symptoms. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label treatment with intermittent theta burst stimulation (iTBS) for six days within a fourteen-day span

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in functional connectivity and motor function post-treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Function-based Accelerated Stimulation Therapy (FAST-therapy)

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Deep brain stimulation (DBS) for Parkinson's disease, particularly targeting the subthalamic nucleus (STN), provides significant motor improvement and allows for reduced medication doses, making it a preferred option for younger patients with motor complications.

While STN DBS has advantages like better motor control and lower current consumption, it requires more intensive postoperative management and carries risks such as infection and hematoma, though the overall benefit-to-risk ratio is considered favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment results: Parkinson's disease. Pollak, P., Fraix, V., Krack, P., et al.[2019]

Deep brain stimulation (DBS) and spinal cord stimulation have been effectively used since the 1960s to treat intractable pain and movement disorders, with high-frequency stimulation (HFS) of the subthalamic nucleus (STN) showing significant benefits for Parkinson's symptoms while reducing the need for medication and its side effects.

Recent advancements in DBS technology, including the use of nanotechnologies and new hardware, are expanding treatment possibilities beyond movement disorders to include conditions like epilepsy, psychiatric disorders, and even obesity, paving the way for innovative neuroprosthetic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional neurosurgery for movement disorders: a historical perspective. Benabid, AL., Chabardes, S., Torres, N., et al.[2009]

Deep brain stimulation (DBS) is a reversible and adjustable treatment for movement disorders like essential tremor and Parkinson's disease, with a low complication risk of ≤ 5% at experienced centers.

Future advancements in DBS technology include directional brain electrodes and 'closed loop' systems that can adapt stimulation based on real-time brain activity, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for movement disorders. Larson, PS.[2021]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05509842?term=AREA%5BBasicSearch%5D(FaST-PD)&rank=10

Function-based Accelerated Stimulation Therapy (FAST ...

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 ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05509842

Function-based Accelerated Stimulation Therapy (FAST ...

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10273730/

Intermittent theta-burst stimulation combined with physical ...

The aim of this study is to demonstrate that iTBS can promote overall function and quality of life in Parkinson's disease patients using ...

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nature.com

nature.com/articles/s43856-025-00744-7

Accelerated symptom improvement in Parkinson's disease ...

The ROAM-DBS study had about 90% power to detect a 2-week (14 days) time difference between two arms to achieve a one-point improvement in PGI-C ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7978118/

Structural correlates underlying accelerated magnetic ...

An accelerated continuous theta‐burst stimulation protocol significantly alleviates motor symptoms in Parkinson's disease. Symptom improvement can be observed ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11785990/

Accelerated symptom improvement in Parkinson's disease ...

This study demonstrates safety and efficacy of internet-based adjustment of DBS therapy, while providing clinical benefit earlier than in-clinic ...

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trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07425-7

Intermittent theta-burst stimulation combined with physical ...

The aim of this study is to demonstrate that iTBS can promote overall function and quality of life in Parkinson's disease patients using physiotherapy.