Recruiting

DBS Therapy

Sponsor:

University of Minnesota

Code:

NCT05962489

Conditions

Deep Brain Stimulation

Parkinson's Disease and Parkinsonism

Dystonia

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Clinically optimized deep brain stimulation

Study Details

Brief summary:

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.

Conditions

Deep Brain Stimulation

Parkinson's Disease and Parkinsonism

Dystonia

Study ID

NCT05962489

Start date

Jun 22, 2023

Status verified date

Mar, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: OFF DBS followed by ON DBS

experimental: ON DBS followed by OFF DBS

Interventions

Clinically optimized deep brain stimulation

Participants will have DBS implanted as standard-of-care. We will be examining the effects of their regular clinical stimulation settings versus no stimulation.

Primary outcome measure

  • pallidopeduncular and pedunculopallidal pathway activation [ Time Frame: 6 months post DBS surgery ]
  • pallidopeduncular and pedunculopallidal pathway activation [ Time Frame: 12 months post DBS surgery ]
  • GPe activation [ Time Frame: 6 months post DBS surgery ]
  • GPe activation [ Time Frame: 12 months post DBS surgery ]
  • Actigraphy [ Time Frame: 6 months post DBS surgery ]
  • Actigraphy [ Time Frame: 12 months post DBS surgery ]
  • Clinical Rating Scales [ Time Frame: 6 months post DBS surgery ]
  • Clinical Rating Scales [ Time Frame: 12 months post DBS surgery ]

Central Contacts and Locations

Central contacts

Emily Weatherill, BS

612-625-4947weath210@umn.edu

Luke Johnson, PhD

612-625-9900joh03032@umn.edu

Locations

University Of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Luke Johnson, PhD

612-625-9900joh03032@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-03-03.