NCT05933681

Brief Summary

The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
0mo left

Started Jul 2023

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Jul 2023May 2026

First Submitted

Initial submission to the registry

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 6, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

December 15, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

June 27, 2023

Last Update Submit

December 5, 2025

Conditions

Parkinson Disease

Keywords

Deep Brain StimulationParkinson DiseaseCognitive impairmentMovement DisordersBrain Diseases

Outcome Measures

Primary Outcomes (2)

  • Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting

    Working memory tasked will be conducted during surgery, and local field potentials (LFPs) will be recorded from the DLPFC both at rest and during task execution, under two conditions: with and without stimulation.

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

  • Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation

    Local field potentials will be recorded from subthalamic nucleus or globus pallidus internus in patients with an existing DBS system with implantable pulse generator capable of recording local field potentials. Recordings will be performed at rest and during a working memory task, with DBS on and off.

    1 hour

Study Arms (2)

Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment

EXPERIMENTAL

Neurophysiology recordings will be performed from dorsolateral prefrontal cortex (DLPFC) during deep brain stimulation surgery, with and without STN or GPI stimulation, at rest and during a working memory task.

Device: Neural recordings and stimulation

Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation

EXPERIMENTAL

Neurophysiology recordings will be performed from subthalamic nucleus (STN) or globus pallidus internus (GPI) with stimulation on and off, at rest and during a working memory task, in patients who have previously been implanted with DBS and have implantable pulse generators capable of recording local field potentials.

Device: Neural recordings and stimulation

Interventions

Neural recordings and stimulationDEVICE

Neural activities from the dorsolateral prefrontal cortex and implanted DBS generator will be recorded, during resting and working memory tasks, and with the DBS target turned on and off.

Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairmentNeurophysiology biomarkers of DBS mediated cognitive impairment following chronic 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 (Arm 1)
  • Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2)
  • Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist
  • Age at least 18
  • Able to participate in intraoperative testing
  • English speaking

You may not qualify if:

  • Age less than 18
  • Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseCognitive DysfunctionMovement DisordersBrain Diseases

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Sarah K Bick, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurosurgery

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

July 6, 2023

Primary Completion

July 30, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

December 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)