Status:
RECRUITING
Globus Pallidus Stimulation to Treat Insomnia
Lead Sponsor:
Mayo Clinic
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
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 insomn...
Eligibility Criteria
Inclusion
- 40-80 years of age
- Symptomatic with Parkinsonism for 7-20 years
- Severe insomnia based on ISI score
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04116996
Start Date
January 1 2019
End Date
January 1 2029
Last Update
December 1 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224