Globus Pallidus Stimulation to Treat Insomnia
GPS-I
Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
1 other identifier
interventional
10
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Jan 2019
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
December 1, 2025
November 1, 2025
10 years
October 2, 2019
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Insomnia Severity Index
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)
3 and 6 months
Secondary Outcomes (1)
Change in Parkinson's Sleep Scale (PDSS)
3 and 6 months
Study Arms (1)
Adults with Parkinson's disease and severe insomnia
EXPERIMENTAL1 arm study
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Castillo, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 2, 2019
First Posted
October 7, 2019
Study Start
January 1, 2019
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share