Actively Recruiting
Globus Pallidus Stimulation to Treat Insomnia
Led by Mayo Clinic · Updated on 2025-12-01
10
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Globus Pallidus Stimulation to Treat Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years
- Parkinsonism symptoms lasting 7 to 20 years
- Severe insomnia based on Insomnia Severity Index score
You will not qualify if you...
- Clinically significant dementia with MMSE score less than 23
- Hoehn & Yahr stage I or V Parkinson's disease
- Other major neurological or psychiatric diseases
- Previous pallidotomy or thalamotomy brain surgeries
- Previous placement of other implantable devices
- Secondary (non-idiopathic) parkinsonism
- Inability to travel to Jacksonville for study visits
- Severe sleep apnea
- Insomnia caused by pain or untreated mood disorders
- Contraindications to 3T MRI
- Circadian rhythm sleep disorders
- Current use of hypnotic medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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