Sensing brain stimulation lengthens sleep
- Trial ID
- NCT05070013
- Official Title
- Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair
- Goal
- Sensing brain stimulation lengthens sleep
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Nebraska
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Parkinson's Disease, Sleep Fragmentation
- Interventions
- Deep Brain Stimulation
Summary For Families
The goal is to reduce sleep fragmentation in Parkinson's, helping people get longer, more restorative stretches of sleep and repair disrupted sleep architecture that can worsen daytime function. The approach implants a sensing deep brain stimulator in the subthalamic nucleus that records local field potentials, uses those brain rhythms as biomarkers to trigger or adjust electrical stimulation during sleep, and thereby aims to consolidate sleep while working alongside stable levodopa and other anti-PD medications rather than replacing them. The study seeks adults 18 to 80 with idiopathic Parkinson's for at least 4 years who have significant motor problems despite optimized meds and who are approved for STN DBS, and excludes people with major cognitive impairment, severe untreated depression, obstructive sleep apnea, or restless legs. Participants must be able to get long-term follow up at the study site and manage the device recharge process.
Locations
- University of Nebraska Medical Center, Omaha, Nebraska, United States
- University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation. The goal is to reduce sleep fragmentation in Parkinson's, helping people get longer, more restorative stretches of sleep and repair disrupted sleep architecture that can worsen daytime function. The approach implants a sensing deep brain stimulator in the subthalamic nucleus that records local field potentials, uses those brain rhythms as biomarkers to trigger or adjust electrical stimulation during sleep, and thereby aims to consolidate sleep while working alongside stable levodopa and other anti-PD medications rather than replacing them. The study seeks adults 18 to 80 with idiopathic Parkinson's for at least 4 years who have significant motor problems despite optimized meds and who are approved for STN DBS, and excludes people with major cognitive impairment, severe untreated depression, obstructive sleep apnea, or restless legs. Participants must be able to get long-term follow up at the study site and manage the device recharge process.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 4 years and 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.