Intracranial Recordings to Characterize Action Regulation Mechanisms

Humans can rapidly regulate actions according to evolving environmental demands, however, impairments of action regulation have been identified across a number of neurological disorders including Parkinson's Disease (PD). A key component of action regulation is action inhibition that occurs when stopping unwanted or inappropriate actions. There is mounting evidence that action inhibition also plays a critical part in selecting between competing alternative actions and switching to new actions in response to environmental changes. The investigators hypothesize that stop circuitry (involving frontal-subthalamic nucleus (STN) pathways) are involved in inhibiting unselected actions during action selection with competing alternatives (in the absence of overt stopping) and that switching motor plans also engages stopping circuitry (involving prefrontal-STN pathways) for cancelling the ongoing action, before changing to new one. The overall goal is to delineate the neural circuitry underlying a broad array of action regulation functions that involve inhibitory control, how these functions interrelate, and how they are implemented within brain networks. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Subcortical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older.
• Diagnosis of Parkinson's disease (rigid-akinetic subtype or tremor-dominant) based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia).
• Clinical indication and decision to proceed with subthalamic nucleus deep brain stimulation implantation.
• L-dopa responsive with clearly defined "on" periods, with at least 30% improvement in UPDRS III scores on vs off medications (with documented ON UPDRS III scores).
• Willingness and ability to cooperate during conscious operative procedure for up to 30 minutes.
• Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities.

Exclusion Criteria:

• Patients with recent use (within one week) of anticoagulant or antiplatelet agent use.
• Neurocognitive testing indicating amnestic cognitive deficits (MOCA < 24).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson's disease patients; This group consists of Parkinson's disease patients who are undergoing deep brain stimulation surgery for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation.	Other: Subcortical Stimulation; Subcortical simulation of the deep brain stimulation surgery target site will be applied by clinically placed deep brain stimulation electrodes at the previously determined therapeutic setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical ECoG and Subcortical recordings	Cortical ECoG and subcortical LFP recordings will occur during DBS implantation surgery during the behavioral assessments	Intra-operative
Behavioral assessment	Each patient will complete a task that assesses action regulation through a decision making, stopping, and switching task.	Intra-operative

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: STU-2024-0280; 1U01NS132788-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No