Nighttime Deep Brain Stimulation w… for Parkinson's (NCT07110376)
Nighttime brain stimulation improves sleep
- Trial ID
- NCT07110376
- Official Title
- Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study
- Goal
- Nighttime brain stimulation improves sleep
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- The Cleveland Clinic
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- Nighttime Deep Brain Stimulation with Varying Amplitude Settings
Summary For Families
The study wants to learn how different nighttime deep brain stimulation settings change sleep-related brain activity and sleep quality, so future adaptive systems can adjust stimulation correctly during sleep. Researchers will use implanted stimulators that can record brain signals from the movement-control area called the subthalamic nucleus and try different stimulation currents at night to see how each level affects brain rhythms and sleep. They are looking for adults over 18 with idiopathic Parkinson's who already have bilateral, recording-capable deep brain stimulators with stable settings for at least three months, who report some sleep problems, can walk on their own, and can give informed consent; people with other brain diseases, certain untreated sleep disorders, dementia, substance abuse, or night shift work are excluded. It is a small, single-center exploratory study with a randomized crossover design and about 10 participants.
Locations
- Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Nighttime Deep Brain Stimulation with Varying Amplitude Settings. The study wants to learn how different nighttime deep brain stimulation settings change sleep-related brain activity and sleep quality, so future adaptive systems can adjust stimulation correctly during sleep. Researchers will use implanted stimulators that can record brain signals from the movement-control area called the subthalamic nucleus and try different stimulation currents at night to see how each level affects brain rhythms and sleep. They are looking for adults over 18 with idiopathic Parkinson's who already have bilateral, recording-capable deep brain stimulators with stable settings for at least three months, who report some sleep problems, can walk on their own, and can give informed consent; people with other brain diseases, certain untreated sleep disorders, dementia, substance abuse, or night shift work are excluded. It is a small, single-center exploratory study with a randomized crossover design and about 10 participants.
- 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 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?
- The study is a 6-week in-home monitoring protocol and includes one night of polysomnography.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Brain wave recording (EEG) (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.