Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05933681

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Neural recordings and stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment 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 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.
Experimental: Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation 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 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.

Arm

Intervention/Treatment

Experimental: Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment

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

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.

Experimental: Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation

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

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.

Outcome Measures

Primary Outcome Measures

Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting [Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours]
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.
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation [1 hour]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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