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?
- 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.
- 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.