Accelerated Brain Stimulation for Parkinson's Disease
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.
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 data supports the effectiveness of the treatment Function-based Accelerated Stimulation Therapy (FAST-therapy) for Parkinson's Disease?
Research shows that high-frequency deep brain stimulation, similar to FAST-therapy, improves movement speed in Parkinson's patients by targeting brain areas involved in motor control. This type of stimulation has been effective in reducing symptoms like tremors and improving overall motor function, suggesting potential benefits for FAST-therapy.12345
Is accelerated brain stimulation therapy safe for humans?
Deep brain stimulation (DBS), a similar treatment, is generally considered safe with low risks of complications like infection, bleeding, or device issues, especially at experienced centers. However, specific safety data for accelerated brain stimulation therapy is not available in the provided research.36789
How does FAST-therapy differ from other treatments for Parkinson's disease?
FAST-therapy is unique because it uses accelerated brain stimulation, potentially offering more precise and adaptable treatment compared to traditional deep brain stimulation, which often uses constant settings. This approach may allow for better management of symptoms with fewer side effects by adjusting stimulation based on real-time brain activity.13101112
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive open-label treatment with intermittent theta burst stimulation (iTBS) for six days within a fourteen-day span
Follow-up
Participants are monitored for changes in functional connectivity and motor function post-treatment
Treatment Details
Interventions
- Function-based Accelerated Stimulation Therapy (FAST-therapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor