Deep Brain Stimulation for Insomnia (GPS-I Trial)

Palo Alto (17 mi)

Overseen byPablo Castillo, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

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).

Eligibility Criteria

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.

Exclusion Criteria

I have had a previous brain surgery for movement disorders.

My Parkinson's disease is caused by another condition.

My Parkinson's disease is at an early or very advanced stage.

I have been diagnosed with severe sleep apnea.

I have trouble sleeping because of pain or an untreated mood disorder.

I do not have any major neurological or psychiatric conditions.

I have a disorder affecting my sleep-wake cycle.

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: Adults with Parkinson's disease and severe insomniaExperimental Treatment1 Intervention

1 arm study