Globus pallidus externa stimulation for insomnia in Parkinson disease
Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
This trial will try turning on an extra deep brain stimulation electrode aimed at the globus pallidus externa to see if it improves severe insomnia in people with Parkinson disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04116996 on ClinicalTrials.gov |
What this trial studies
Participants with Parkinson disease and severe insomnia will receive unilateral deep brain stimulation targeted to the globus pallidus externa by turning on an additional implanted electrode. The team will compare sleep symptoms and insomnia severity before and after GPe stimulation, using validated measures such as the Insomnia Severity Index. Eligible participants are 40–80 years old, have 7–20 years of Parkinsonism, and have no significant dementia or other major neurologic or psychiatric disorders. Procedures and post-operative follow-up visits will take place at the Mayo Clinic in Jacksonville, Florida.
Who should consider this trial
Good fit: Ideal candidates are people aged 40–80 with 7–20 years of Parkinson disease who have severe insomnia by ISI score, no clinically significant dementia or other major neurologic/psychiatric disease, and who can travel to Jacksonville for post-operative visits.
Not a fit: Patients with severe sleep apnea, insomnia driven by pain or untreated mood disorders, circadian rhythm sleep disorders, prior pallidotomy/thalamotomy or other implanted devices, significant dementia, or secondary (non-idiopathic) parkinsonism are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, targeted GPe stimulation could reduce insomnia symptoms and improve sleep quality in people with Parkinson disease.
How similar studies have performed: This approach is relatively novel: while DBS has been used for motor symptoms and some prior work suggests DBS can affect sleep, targeted stimulation of the GPe for insomnia is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Pablo Castillo, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.