Deep Brain Stimulation for Parkinson's (NCT05070013)
Reduce nighttime awakenings with stimulation
- 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
- Reduce nighttime awakenings with stimulation
- 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 the sleep problems people with Parkinson's often have, like broken sleep, frequent awakenings, low dream sleep, and daytime sleepiness, so they feel more rested and their quality of life improves. The approach uses deep brain stimulation placed in a small brain area called the subthalamic nucleus, with a new adaptive method that uses signals from the implanted electrodes to detect sleep stages and adjust stimulation during the night; each participant will try adaptive stimulation, regular constant stimulation, and a no-stimulation week while sleep is tracked with questionnaires, a wrist-like activity monitor, and overnight sleep studies. The study is for adults 18 to 80 who have had Parkinson's for at least four years, whose motor symptoms are not well controlled by medicine and who have been approved for subthalamic nucleus deep brain stimulator surgery, with stable Parkinson's medications; people with untreated sleep apnea, restless legs, major cognitive problems, or other medical risks for surgery are not eligible.
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 the sleep problems people with Parkinson's often have, like broken sleep, frequent awakenings, low dream sleep, and daytime sleepiness, so they feel more rested and their quality of life improves. The approach uses deep brain stimulation placed in a small brain area called the subthalamic nucleus, with a new adaptive method that uses signals from the implanted electrodes to detect sleep stages and adjust stimulation during the night; each participant will try adaptive stimulation, regular constant stimulation, and a no-stimulation week while sleep is tracked with questionnaires, a wrist-like activity monitor, and overnight sleep studies. The study is for adults 18 to 80 who have had Parkinson's for at least four years, whose motor symptoms are not well controlled by medicine and who have been approved for subthalamic nucleus deep brain stimulator surgery, with stable Parkinson's medications; people with untreated sleep apnea, restless legs, major cognitive problems, or other medical risks for surgery are not eligible.
- 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?
- 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 4 years and 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?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Brain wave recording (EEG) (non-invasive); Questionnaires & surveys (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.