Deep brain stimulation therapy for sleep issues in Parkinson's disease
Sleep-specific DBS Therapy in Parkinson's Disease
This study is testing if deep brain stimulation can help people with Parkinson's disease improve their sleep problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05962489 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- University Of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Emily Weatherill, BS
- Email: weath210@umn.edu
- Phone: 612-625-4947
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.