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Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05933681
Enrollment
160
Registered
2023-07-06
Start date
2023-07-06
Completion date
2027-05-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation, Parkinson Disease, Cognitive impairment, Movement Disorders, Brain Diseases

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.

Interventions

DEVICENeural recordings and stimulation

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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation settingBaseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hoursWorking 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.
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation1 hourLocal 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSarah K Bick, MD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026