Theta-Burst Stimulation for Parkinson's Disease with Mild Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether intermittent theta burst stimulation (iTBS), a special type of brain stimulation, can help people with Parkinson's disease who also experience mild memory or thinking problems. The treatment is non-invasive, meaning it doesn’t involve surgery, and aims to improve brain function safely. Suitable participants have been diagnosed with Parkinson's disease, notice mild difficulties with memory or thinking, and have been stable on their medications for at least 30 days. As an unphased trial, this study offers an opportunity to contribute to groundbreaking research that could enhance treatment options for Parkinson's patients.
What prior data suggests that this method is safe for treating mild cognitive impairment in Parkinson's disease?
Studies have shown that intermittent theta-burst stimulation (iTBS) is generally safe and well-tolerated. Previous research indicates that no serious side effects occurred in earlier studies of iTBS. This treatment has been used for conditions like depression and has FDA approval for that purpose, suggesting its safety. Possible side effects include mild headaches, scalp irritation, or tiredness, but these are usually temporary and not severe. Overall, iTBS appears to be a promising and safe treatment option.12345
Why are researchers excited about this trial?
Most treatments for Parkinson's disease with mild cognitive impairment, like medications and deep brain stimulation, primarily aim to manage motor symptoms or enhance dopamine activity. However, accelerated intermittent theta-burst stimulation (iTBS) represents an innovative approach that targets the brain's right superior parietal lobule using magnetic pulses to potentially improve both motor and cognitive functions. Researchers are excited because iTBS is non-invasive and can deliver rapid results, with sessions completed in just a few days. This treatment might offer a new, efficient way to address cognitive impairments, which are often harder to treat with existing options.
What evidence suggests that this treatment might be an effective treatment for Parkinson's disease with mild cognitive impairment?
Research has shown that intermittent theta-burst stimulation (iTBS) can assist individuals with mild memory and thinking problems. Earlier studies demonstrated improved memory and cognitive skills in patients after receiving iTBS. This treatment delivers quick bursts of energy to specific brain areas, enhancing communication between brain cells. It is considered safe and has shown promise in improving cognitive abilities. In this trial, participants will receive accelerated iTBS targeting the right superior parietal lobule. Although more research is needed specifically for Parkinson's disease with mild memory issues, early results are encouraging.
Are You a Good Fit for This Trial?
This trial is for people diagnosed with Parkinson's disease who also have mild problems with memory or thinking (mild cognitive impairment).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo accelerated intermittent theta burst stimulation (iTBS) targeting the right superior parietal lobule over three consecutive days, with 10 sessions per day.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive and functional changes.
Long-term follow-up
Participants are assessed for changes in cognitive and functional measures one month post-intervention.
What Are the Treatments Tested in This Trial?
Interventions
- Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)
Trial Overview
The study is testing a short-term, high-dose non-invasive brain stimulation called intermittent theta-burst stimulation (iTBS) applied to a specific area of the brain, to see if it helps improve thinking in people with Parkinson’s and mild cognitive issues.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will undergo accelerated intermittent theta burst stimulation (iTBS) targeting the right superior parietal lobule (rSPL) using a MagVenture MagPro system with a cooled butterfly coil, with Brainsight neuronavigation identifying the stimulation site. Resting motor threshold (rMT) will be determined on the first stimulation visit using Parameter Estimation by Sequential Testing (PEST). Stimulation for the intervention will be delivered at 120% rMT. Stimulation sessions will occur over three consecutive days. Each day will include 10 sessions separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; \~190 seconds), totaling 6,000 pulses/day and 18,000 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) will be assessed before and after sessions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Citations
Bilateral intermittent theta burst stimulation over the primary ...
Real iTBS induced a maximum improvement of nine points on the Movement Disorder Society-Unified PD Rating Scale part III, with clinical responders (≥20% ...
NCT07701785 | Superior Parietal iTBS for PD-MCI
This project therefore aims to evaluate the safety, tolerability and feasibility of a three-day a-iTBS intervention stimulating the rSPL with 18,000 total ...
Intermittent Theta-Burst Stimulation for Depressive ...
Line Graphs Showing Clinical Outcomes in Patients With Parkinson Disease Depression Receiving Intermittent Theta-Burst Stimulation (iTBS) ...
Effects of intermittent theta-burst stimulation on cognition and ...
Significant cognitive improvements were observed at week. No adverse events were reported. iTBS can produce delayed cognitive enhancement in ...
Accelerated TMS for Apathy in Parkinson's Disease
Studies have shown that intermittent theta-burst stimulation (iTBS) is generally safe and well-tolerated. The FDA has approved iTBS for treating depression,
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