Brain stimulation reduces sleep fragmentation
- Trial ID
- NCT06914466
- Official Title
- Neural Mechanisms and Clinical Applications of Deep Brain Stimulation for Modulating Sleep Dysregulation in Parkinson's Disease
- Goal
- Brain stimulation reduces sleep fragmentation
- Status
- RECRUITING
- Sponsor
- Xuanwu Hospital, Beijing
- Study Type
- OBSERVATIONAL
- Enrollment
- 20 participants
- Conditions
- Deep Brain Stimulation, Parkinson's Disease and Parkinsonism, Sleep Disorder
- Interventions
- Deep Brain Stimulation
Summary For Families
The team wants to understand how stimulating the subthalamic nucleus can change the brain circuits that control sleep in Parkinson's, and whether specific stimulation patterns can reduce sleep fragmentation, REM sleep behavior problems, or daytime sleepiness. Using people who already have bilateral STN-DBS with the Medtronic Percept PC, researchers will compare sleep questionnaires, sleep studies, and the device's recorded brain signals to see which stimulation settings link to better sleep, STN-DBS delivers targeted electrical pulses that reshape overactive motor and nonmotor networks while the Percept records local field potentials to reveal neural activity behind sleep changes. They plan to enroll about 20 adults age 19 to 80 who had bilateral STN-DBS with the Percept PC and can complete follow-up, excluding those with other brain surgery, secondary Parkinsonism, other major nervous system diseases, severe medical or psychiatric illness, or major cognitive or communication barriers.
Locations
- Xuanwu Hospital,Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation. The team wants to understand how stimulating the subthalamic nucleus can change the brain circuits that control sleep in Parkinson's, and whether specific stimulation patterns can reduce sleep fragmentation, REM sleep behavior problems, or daytime sleepiness. Using people who already have bilateral STN-DBS with the Medtronic Percept PC, researchers will compare sleep questionnaires, sleep studies, and the device's recorded brain signals to see which stimulation settings link to better sleep, STN-DBS delivers targeted electrical pulses that reshape overactive motor and nonmotor networks while the Percept records local field potentials to reveal neural activity behind sleep changes. They plan to enroll about 20 adults age 19 to 80 who had bilateral STN-DBS with the Percept PC and can complete follow-up, excluding those with other brain surgery, secondary Parkinsonism, other major nervous system diseases, severe medical or psychiatric illness, or major cognitive or communication barriers.
- Who can participate?
- Participants must be between 19 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.