NCT04116996Recruiting
Globus Pallidus Stimulation to Treat Insomnia
Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 2 Oct 2019
- Start date
- 1 Jan 2019
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Mayo Clinic
- Diseases
- Parkinson disease
- NCT number
- NCT04116996
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Jan 2019 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pallidotomy or thalamotomy
- Previous placement of other implantable devices
Other illness
- Clinically significant dementia (MMSE \<23)
- Hoehn \& Yahr \[Hoehn, 1967 #1839\] stage I or V disease
- Other significant neurological or psychiatric disease
- Insomnia due to pain or untreated mood disorder
- Circadian rhythm sleep disorders.
Other
- Secondary parkinsonism (non-idiopathic parkinsonism)
- Inability to travel to Jacksonville for post-operative study visits
- Severe sleep apnea
- Contraindications to 3T MRI
- Current use of hypnotics
Who the study is looking for
- 40-80 years of age
- Symptomatic with Parkinsonism for 7-20 years
- Severe insomnia based on ISI score
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.