STN DBS - Theta Burst for Parkinson's (NCT05307055)
Improve cognition and motor function
- Trial ID
- NCT05307055
- Official Title
- Theta Burst Subthalamic Nucleus Deep Brain Stimulation for Cognitive and Motor Improvements in Parkinson's Disease
- Goal
- Improve cognition and motor function
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Southern California
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease
- Interventions
- STN DBS - Theta Burst, STN DBS - Gamma
Summary For Families
Goal: to see whether changing the pattern of deep brain stimulation can improve thinking and movement in people with Parkinson's who already have a deep brain stimulator implanted. Approach: researchers will compare the usual high-frequency "gamma" setting with a different pattern called "theta burst" by reprogramming each person’s implanted device in a randomized, double-blind crossover design, keeping the baseline voltage the same, and measuring short-term and longer-term effects with cognitive tests, movement exams, and functional magnetic resonance imaging scans at baseline and at weeks 15 and 27 for compatible devices. Eligibility: adults over 18 who already have bilateral deep brain stimulation, are on a stable medication regimen for at least three months, can give consent and attend visits; people with a history of seizures, dementia, or major substance abuse are not eligible.
Locations
- University of Southern California Keck School of Medicine, Los Angeles, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying STN DBS - Theta Burst. Goal: to see whether changing the pattern of deep brain stimulation can improve thinking and movement in people with Parkinson's who already have a deep brain stimulator implanted. Approach: researchers will compare the usual high-frequency "gamma" setting with a different pattern called "theta burst" by reprogramming each person’s implanted device in a randomized, double-blind crossover design, keeping the baseline voltage the same, and measuring short-term and longer-term effects with cognitive tests, movement exams, and functional magnetic resonance imaging scans at baseline and at weeks 15 and 27 for compatible devices. Eligibility: adults over 18 who already have bilateral deep brain stimulation, are on a stable medication regimen for at least three months, can give consent and attend visits; people with a history of seizures, dementia, or major substance abuse are not eligible.
- Who can participate?
- Participants must be at least 18 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 7 years and 8 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?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Thinking & memory tests (non-invasive); Walking & movement tests (non-invasive). Confirm the full schedule with the study coordinator.