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NCT05962489Recruiting

Sleep-specific DBS Therapy in Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 3 Mar 2026

Brief summary (registry, in English)

Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
64 (estimated)
First submitted
28 Jun 2023
Start date
22 Jun 2023
Primary completion date
1 Aug 2027
Lead sponsor
University of Minnesota
NCT number
NCT05962489

What you commit to

  • Study type: Interventional
  • Planned participants: 64
  • From 22 Jun 2023 to the primary completion date, 1 Aug 2027
  • 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

  • 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

Other illness

  • Other significant neurological disorder
  • History of dementia

Other

  • 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

Who the study is looking for

  • 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)

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.