DEEP BRAIN STIMULATION for Parkinson's (NCT04116996)
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
Summary For Families
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?
- 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 10 years.
- 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.