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Globus Pallidus Stimulation to Treat Insomnia

RECRUITINGN/ASponsored by Mayo Clinic
Actively Recruiting
PhaseN/A
SponsorMayo Clinic
Started2019-01-01
Est. completion2029-01-01
Eligibility
Age40 Years – 80 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04116996

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

Age: 40 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Parkinson DiseaseParkinson's Disease

Locations1 site

Mayo Clinic in Florida
Jacksonville, Florida, 32224
Pablo R Castillo, MD904-9532000castillo.pablo@mayo.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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