Improve sleep using brain pulses
- Trial ID
- NCT07110376
- Official Title
- Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study
- Goal
- Improve sleep using brain pulses
- 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 DREAMS-PD team wants to know whether changing the amplitude of overnight deep brain stimulation changes brain activity during sleep and may affect overnight symptoms like movement or sleep quality. They will use the Medtronic Percept PC, which delivers electrical pulses to the subthalamic nucleus to calm abnormal Parkinson's-related brain rhythms and also records local brain signals; by varying the stimulation amplitude at night they can see how different settings alter sleep-related neural patterns while keeping daytime therapy and medications stable. Adults over 18 with idiopathic Parkinson's who already have bilateral Percept PC STN implants with settings optimized for at least three months, report some sleep problems, can walk independently, do not have dementia or untreated significant sleep apnea, and keep sleep medications stable are eligible.
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 DREAMS-PD team wants to know whether changing the amplitude of overnight deep brain stimulation changes brain activity during sleep and may affect overnight symptoms like movement or sleep quality. They will use the Medtronic Percept PC, which delivers electrical pulses to the subthalamic nucleus to calm abnormal Parkinson's-related brain rhythms and also records local brain signals; by varying the stimulation amplitude at night they can see how different settings alter sleep-related neural patterns while keeping daytime therapy and medications stable. Adults over 18 with idiopathic Parkinson's who already have bilateral Percept PC STN implants with settings optimized for at least three months, report some sleep problems, can walk independently, do not have dementia or untreated significant sleep apnea, and keep sleep medications stable are 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?
- 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 7 months.
- 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.