NCT04715984

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
38mo left

Started Jun 2021

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jun 2021Aug 2029

First Submitted

Initial submission to the registry

January 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 2, 2021

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

8.2 years

First QC Date

January 14, 2021

Last Update Submit

February 16, 2026

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (2)

  • Changes in caudate DLPFC beta coherence

    Caudate DLPFC coherence will be computed at rest and during the gambling task and correlated with cognitive metrics

    Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours

  • Changes in gambling task performance with neural stimulation

    The gambling task will involve seeing a series of cards presented on the screen and pressing a button to respond with a bet. Gambling task performance will be compared between stimulated and non stimulated blocks and between stimulation targets

    Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours

Secondary Outcomes (1)

  • Change in beta power with neural stimulation

    Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours

Study Arms (1)

Neural recordings and stimulation

EXPERIMENTAL
Other: Neurophysiology recordingsOther: Neural stimulation

Interventions

Neurophysiology recordingsOTHER

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

Neural recordings and stimulation
Neural stimulationOTHER

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

Neural recordings and stimulation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sarah Bick, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Long, BS

CONTACT

615-421-3046isabel.long@vumc.org

Sarah Bick, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurosurgery, Principal Investigator

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 20, 2021

Study Start

June 2, 2021

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

February 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)