Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT04715984

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Neurophysiology recordings

Neural stimulation

Study Details

Brief summary:

The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.

Conditions

Parkinson Disease

Study ID

NCT04715984

Start date

Jun 2, 2021

Status verified date

Jan, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
  • Planned clinical electrode trajectory that contacts caudate
  • Age greater than or equal to 40
  • Diagnosis of Parkinson's disease
  • Able to participate in intraoperative testing
  • English speaking

Exclusion criteria:

  • Age less than 40
  • Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)
  • Movement disorder other than Parkinson's disease

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Neural recordings and stimulation

Interventions

Neurophysiology recordings

Neurophysiology recordings will be performed during deep brain stimulation surgery and their relationship to performance on a gambling task evaluated

Neural stimulation

Neural stimulation will be delivered during a gambling task and its impact on task performance quantified

Primary outcome measure

  • Changes in caudate DLPFC beta coherence [ Time Frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours ]
  • Changes in gambling task performance with neural stimulation [ Time Frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours ]

Central Contacts and Locations

Central contacts

Lucas Chang, BA

615-421-3046lucas.m.chang@vumc.org

Sarah Bick, MD

615-343-9822Sarah.Bick@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Lucas Chang, BA

615-421-3046lucas.m.chang@vumc.org

Principal Investigator:

Sarah Bick, MD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jun 12, 2026

Last verified

Jan, 2026

Keywords

  • Deep Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-06-12.