Globus Pallidus Stimulation to Treat Insomnia (NCT04116996)
Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (13 items).
Location: Mayo Clinic in Florida — Jacksonville, Florida
Age range: 40 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Mayo Clinic in Florida — Jacksonville, Florida
📞 Contact the Study Coordinator
Phone: (904) 953-2000
Email: castillo.pablo@mayo.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Parkinson Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.