Improve insomnia with pallidal stimulation
- Trial ID
- NCT04116996
- Official Title
- Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
- Goal
- Improve insomnia with pallidal stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Mayo Clinic
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- DEEP BRAIN STIMULATION
Plain-Language Summary
Aiming to ease the severe insomnia that many people with Parkinson's struggle with, this trial targets nighttime wakefulness and poor sleep quality that do not respond well to medications. It implants a deep brain stimulation lead in the external segment of the globus pallidus, delivering adjustable electrical pulses to modulate basal ganglia circuits that influence sleep and arousal, and it is used in addition to existing treatments like levodopa rather than replacing them. By changing abnormal firing patterns in that region, stimulation may reduce the brain overactivity that fragments sleep and help restore more stable sleep architecture. The study seeks people aged 40 to 80 with 7 to 20 years of Parkinsonism and severe insomnia on the ISI, and it excludes those with significant dementia, very early or very advanced disease, severe sleep apnea, prior pallidal/thalamic surgeries or other implants, current hypnotic use, or insomnia due to untreated mood disorder or pain.
Locations
- Mayo Clinic in Florida, Jacksonville, Florida, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DEEP BRAIN STIMULATION. Aiming to ease the severe insomnia that many people with Parkinson's struggle with, this trial targets nighttime wakefulness and poor sleep quality that do not respond well to medications. It implants a deep brain stimulation lead in the external segment of the globus pallidus, delivering adjustable electrical pulses to modulate basal ganglia circuits that influence sleep and arousal, and it is used in addition to existing treatments like levodopa rather than replacing them. By changing abnormal firing patterns in that region, stimulation may reduce the brain overactivity that fragments sleep and help restore more stable sleep architecture. The study seeks people aged 40 to 80 with 7 to 20 years of Parkinsonism and severe insomnia on the ISI, and it excludes those with significant dementia, very early or very advanced disease, severe sleep apnea, prior pallidal/thalamic surgeries or other implants, current hypnotic use, or insomnia due to untreated mood disorder or pain.
- Who can participate?
- Participants must be between 40 Years and 80 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 10 years.