Deep Brain Stimulation for Parkinson's (NCT06914466)
Improve sleep with brain stimulation
- Trial ID
- NCT06914466
- Official Title
- Neural Mechanisms and Clinical Applications of Deep Brain Stimulation for Modulating Sleep Dysregulation in Parkinson's Disease
- Goal
- Improve sleep with brain stimulation
- 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 goal is to understand how deep brain stimulation in the subthalamic nucleus affects sleep in Parkinson's, including which sleep problems get better or worse, and to find brain signal patterns that could guide sleep-targeted stimulation. The approach pairs a wearable polysomnography device, which records sleep stages, with recordings of local brain electrical signals called local field potentials from the implanted stimulation system, comparing nights with the stimulator off and on, then using machine learning to pick signals that predict sleep changes and set an adaptive stimulation plan. After that, participants will try one month of adaptive stimulation that changes based on their brain signals, with sleep tracked and then compared to one month of standard continuous stimulation. The trial will enroll 20 people aged 19 to 80 who have typical Parkinson's and already have bilateral subthalamic nucleus deep brain stimulation systems (Medtronic Percept PC), and who can complete follow-up; people with other brain surgery, other Parkinsonism types, serious medical or mental illness, or who cannot consent are excluded.
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 goal is to understand how deep brain stimulation in the subthalamic nucleus affects sleep in Parkinson's, including which sleep problems get better or worse, and to find brain signal patterns that could guide sleep-targeted stimulation. The approach pairs a wearable polysomnography device, which records sleep stages, with recordings of local brain electrical signals called local field potentials from the implanted stimulation system, comparing nights with the stimulator off and on, then using machine learning to pick signals that predict sleep changes and set an adaptive stimulation plan. After that, participants will try one month of adaptive stimulation that changes based on their brain signals, with sleep tracked and then compared to one month of standard continuous stimulation. The trial will enroll 20 people aged 19 to 80 who have typical Parkinson's and already have bilateral subthalamic nucleus deep brain stimulation systems (Medtronic Percept PC), and who can complete follow-up; people with other brain surgery, other Parkinsonism types, serious medical or mental illness, or who cannot consent are excluded.
- 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?
- 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 2 years.
- 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 an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- You will have preoperative assessments with two nights of PSG, a 1 month postoperative visit to optimize DBS, and follow-up evaluations at 3, 6, and 12 months that include two nights of in-hospital PSG.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.