Deep Brain Stimulation for Insomnia

(GPS-I Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Hypnotics

Disqualifiers: Dementia, Neurological disease, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus pallidus externa (GPe) region of the brain will improve insomnia (sleep).

Who Is on the Research Team?

Pablo Castillo, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people aged 40-80 with Parkinson's Disease who've had symptoms for 7-20 years and suffer from severe insomnia. They shouldn't have dementia, previous brain surgeries like pallidotomy or thalamotomy, be using sleeping pills, or have other major neurological issues. Also, they must be able to visit Jacksonville for follow-ups.

Inclusion Criteria

I have severe trouble sleeping.

I am between 40 and 80 years old.

I have had Parkinson's symptoms for 7 to 20 years.

Exclusion Criteria

You have severe memory and thinking problems.

I have had a previous brain surgery for movement disorders.

My Parkinson's disease is caused by another condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive unilateral DBS electrode stimulation to the globus pallidus externa (GPe) region

6 months

Follow-up

Participants are monitored for changes in sleep quality and insomnia severity

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Globus Pallidus Stimulation

Trial Overview The study is testing if activating an extra DBS electrode targeting the globus pallidus externa in the brain can help improve sleep in Parkinson's patients. It involves unilateral deep brain stimulation as a potential treatment for insomnia.

How Is the Trial Designed?

Group I: Adults with Parkinson's disease and severe insomnia Experimental Treatment 1 Intervention

1 arm study

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+