Accelerated intermittent theta-bur… for Parkinson's (NCT07701785)
Test brain stimulation for thinking
- Trial ID
- NCT07701785
- Official Title
- Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease
- Goal
- Test brain stimulation for thinking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Medical University of South Carolina
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Interventions
- Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)
Summary For Families
The goal is to see whether a short, high-dose course of noninvasive brain stimulation, called intermittent theta burst stimulation or iTBS, is a promising, safe, and tolerable way to treat mild thinking problems in Parkinson's. The treatment uses an accelerated version of iTBS delivered over three days to a right-side brain area called the superior parietal lobule, giving 18,000 pulses total; researchers chose this target because loss of key brain chemicals in the back of the brain is strongly linked to cognitive decline and that area helps attention. Before testing whether it improves thinking, the study is focused on showing the three-day, 18,000-pulse approach is safe, tolerable, and feasible in people with Parkinson's and mild cognitive impairment. They are looking for people 50 to 85 years old with a clinical Parkinson's diagnosis and mild cognitive impairment confirmed by a neuropsychologist (low scores on two tests), who have been on stable Parkinson's medicines for at least 30 days and have a caregiver able to complete a questionnaire.
Locations
- Medical University of South Carolina, Charleston, South Carolina, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL). The goal is to see whether a short, high-dose course of noninvasive brain stimulation, called intermittent theta burst stimulation or iTBS, is a promising, safe, and tolerable way to treat mild thinking problems in Parkinson's. The treatment uses an accelerated version of iTBS delivered over three days to a right-side brain area called the superior parietal lobule, giving 18,000 pulses total; researchers chose this target because loss of key brain chemicals in the back of the brain is strongly linked to cognitive decline and that area helps attention. Before testing whether it improves thinking, the study is focused on showing the three-day, 18,000-pulse approach is safe, tolerable, and feasible in people with Parkinson's and mild cognitive impairment. They are looking for people 50 to 85 years old with a clinical Parkinson's diagnosis and mild cognitive impairment confirmed by a neuropsychologist (low scores on two tests), who have been on stable Parkinson's medicines for at least 30 days and have a caregiver able to complete a questionnaire.
- Who can participate?
- Participants must be between 50 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 6 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Stimulation sessions take place over three consecutive days, with 10 sessions each day.