Clinical trial Recruiting at 1 site Interventional Ages 21 and up

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 typeInterventional
Ages21 Years and up
SexAll
Enrollment64 (estimated)
SponsorUniversity of Minnesota
Academic / other
Drugs / interventionsradiation
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedJune 22, 2023
Main results expectedAugust 1, 2027
Study endsAugust 1, 2027
Registry record updatedMarch 3, 2026
Trial IDNCT05962489 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.