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Globus Pallidus Stimulation to Treat Insomnia

RecruitingNAAges 40 Years - 80 YearsAllMayo Clinic
NCT04116996 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • DEEP BRAIN STIMULATION
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Where

1 site
Mayo Clinic in Florida
Jacksonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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