Deep brain stimulation therapy for sleep issues in Parkinson's disease
Official title: Sleep-specific DBS Therapy in Parkinson's Disease
Run by University of Minnesota · NCT05962489 · Data updated 2026-11-12
This study is testing if deep brain stimulation can help people with Parkinson's disease improve their sleep problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | June 22, 2023 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT05962489 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 21 and older with a diagnosis of idiopathic Parkinson's disease who are undergoing or have undergone DBS surgery.
✕Probably not a fit
Patients with significant neurological disorders other than Parkinson's disease or those with a history of dementia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of deep brain stimulation (DBS) therapy on sleep-wake disturbances in individuals with Parkinson's disease (PD). Participants will be those who have DBS systems implanted in specific brain regions, either the globus pallidus or subthalamic nucleus, as part of their routine clinical care. The research aims to understand how DBS influences sleep-related neuronal activity and behavior, potentially leading to targeted interventions for sleep disorders in neurodegenerative diseases. The study will include individuals aged 21 and older who meet specific eligibility criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and overall quality of life for patients with Parkinson's disease.
How similar studies have gone: While there is ongoing research into the effects of DBS on various symptoms of Parkinson's disease, this specific focus on sleep disturbances is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Diagnosis of idiopathic PD * At least 21 years old * Existing or planned 7T brain imaging * Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care * Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away) Exclusion criteria: * Other significant neurological disorder * History of dementia * Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study * Pregnant women * Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip
Where it's running
-
University Of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Study coordinator: Emily Weatherill, BS
- Email: weath210@umn.edu
- Phone: 612-625-4947
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.