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
Plain-Language Summary
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.