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Globus Pallidus Stimulation to Treat Insomnia

Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease

Who can join

Ages 40 to 80 · All sexes

Inclusion Criteria:

* 40-80 years of age
* Symptomatic with Parkinsonism for 7-20 years
* Severe insomnia based on ISI score

Exclusion Criteria:

* Clinically significant dementia (MMSE \<23)
* Hoehn \& Yahr \[Hoehn, 1967 #1839\] stage I or V disease
* Other significant neurological or psychiatric disease
* Previous pallidotomy or thalamotomy
* Previous placement of other implantable devices
* Secondary parkinsonism (non-idiopathic parkinsonism)
* Inability to travel to Jacksonville for post-operative study visits
* Severe sleep apnea
* Insomnia due to pain or untreated mood disorder
* Contraindications to 3T MRI
* Circadian rhythm sleep disorders.
* Current use of hypnotics

About the study

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).

What is being tested

• DEEP BRAIN STIMULATION (device)

Sponsor: Mayo Clinic · Participants: 10 · Started: Jan 1, 2019

Contact the study team

Official record on ClinicalTrials.gov — NCT04116996

Locations in the U.S.

Conditions

• Parkinson's Disease

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.