Globus Pallidus Stimulation to Treat Insomnia

Recruiting now · Not applicable

Conditions studied: Parkinson Disease

In brief

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).

Key facts

Study ID

NCT04116996

Run by

Mayo Clinic

People needed

10

Starts

2019-01-01

Expected to finish

2029-01-01

Last updated by the study team

2025-12-01

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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