Globus Pallidus Stimulation to Treat Insomnia

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: DEEP BRAIN STIMULATION

• Registration Number: NCT04116996
• Lead Sponsor: Mayo Clinic

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults with Parkinson's disease and severe insomnia	DEEP BRAIN STIMULATION	1 arm study

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index	3 and 6 months	Change in self-reported insomnia severity index questionnaire score, using a total score scale of 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), 22-28 is Clinical insomnia (severe)

Secondary Outcome Measures

Name	Time	Method
Change in Parkinson's Sleep Scale (PDSS)	3 and 6 months	Change in self-reported Parkinson's Sleep Scale (PDSS) questionnaire, using a scale of 0 is always and 10 as never

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States