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NCT04116996NARecruiting

Globus Pallidus Stimulation to Treat Insomnia

Mayo Clinic

Start Date

1/1/2019

Completion Date

1/1/2029

Summary

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

Age Range: 40 years to 80 years

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

Interventions

DEVICE

DEEP BRAIN STIMULATION

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Conditions

Parkinson Disease

Locations

Mayo Clinic in Florida

Jacksonville, Florida 32224

United States