RECRUITING

Sleep-specific DBS Therapy in Parkinson's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sleep-specific DBS Therapy in Parkinson's Disease

Quick Facts

Study Start:2023-06-22
Study Completion:2027-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05962489

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of idiopathic PD
  2. * At least 21 years old
  3. * Existing or planned 7T brain imaging
  4. * Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care
  5. * 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)
  1. * Other significant neurological disorder
  2. * History of dementia
  3. * 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
  4. * Pregnant women
  5. * 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

Contacts and Locations

Study Contact

Luke Johnson, PhD
CONTACT
612-625-9900
joh03032@umn.edu
Peter M Grund, BS
CONTACT
612-624-6434
grund130@umn.edu

Study Locations (Sites)

University Of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-22
Study Completion Date2027-08-01

Study Record Updates

Study Start Date2023-06-22
Study Completion Date2027-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Deep Brain Stimulation
  • Parkinson's Disease and Parkinsonism
  • Dystonia