Action Regulation Behavioral

NCT06489483 | Recruiting

• 1 other identifier: STU-2022-0555
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is a neurodegenerative disorder involving a part of the brain that is responsible for motor control, which not only results in changes or disruptions in movement, but also cognitive dysfunctions. Given that the decline of muscle control such as tremors, with difficulty walking or the ability to switch tasks once in movement, greatly affects the quality of daily life. Action regulation is a critical executive function (cognitive control over behavior), which includes actions such as suppressing activity when selecting between options, making decisions about stopping unwanted or inappropriate actions, and switching to new actions in response to environmental changes. Parkinson's disease (PD) has been shown to disrupt action inhibition which can be considered a measure to the progression of PD. The purpose of this research study is to better understand the mechanism of action regulations in PD patients and how action regulations in PD can be improved using dopaminergic treatment, which is a drug that either releases or involves dopamine, which is a neurotransmitter involved in sending signals to nerve cells. You are asked to participate in this research study because you are receiving a dopaminergic medication for treatment of your Parkinson's disease. There is currently no theory that integrates the mechanisms of action regulation into a unified framework, which this study aims to address. The researchers hope to learn more about the mechanisms of action regulation in PD patients and to help decrease action regulation disruptions in PD patients. This study will help characterize the motor behavior of PD patients.

Conditions

Parkinson Disease

Keywords

Levodopa medication; motor cortex; basal ganglia

Outcome Measures

Primary Outcomes (2)

• Stop-Signal Task

  Each patient will complete a joystick-based stop-signal task which assesses reaction time, stop reaction time, accuracy, and joystick traces.

  Baseline

• Switch Task

  Each patient will complete a joystick-based switch task which assess reaction time, switch reaction time, accuracy, and joystick traces.

  Baseline

Study Arms (2)

Parkinson's Disease Patients

EXPERIMENTAL

Patients that have been diagnosed with Parkinson's Disease and are responsive to levodopa medication. Patients will complete a behavioral task.

Behavioral: Action Regulation Movement Task

Healthy Controls

ACTIVE COMPARATOR

Men and women between the ages of 18-80. Spouse of PD patient who participates in this study with no history of any diagnosed neurological disease(s), including movement disorders or cognitive decline. No vision or hearing problems that impair ability to participate with the proposed tasks as assessed by the study investigators.

Behavioral: Action Regulation Movement Task

Interventions

Action Regulation Movement Task BEHAVIORAL

A joystick is utilized to trace the movement of a visual stimulus on a computer screen. In stop signal task, the subjects are required to move a reference dot to reach to a target dot by controlling a joystick and stop their movements when the target turns red. During the switch task, subjects will be required to switch their joystick movement trajectory when the target location is switched to one of the other target locations.

Healthy Controls; Parkinson's Disease Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's Disease by a movement disorder neurologist
• Levodopa responsive with clearly defined "on" periods, with at least 30% improvement in UPDRS III scores on vs off
• Willingness and ability to complete the behavioral experiments for up 3.5 hours
• No vision or hearing problems that impair ability to participate with the proposed tasks as assessed by the study investigators

You may not qualify if:

• Patients with history of secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's Disease
• Patients with a disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocol including cognitive decline, diagnosed forms of dementia, significant memory impairment (MoCA\<23), or hearing loss that prevents adequate communication with researcher
• For Healthy subjects:
• No history any diagnosed neurological disease(s), including movement disorders or cognitive decline
• No vision or hearing problems that impair ability to participate with the proposed tasks as assessed by the study investigators

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of California, Riverside: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Nader Pouratian, MD, Phd

CONTACT

(214) 645-5465; nader.pouratian@utsouthwestern.edu

Sahil Chilukuri, BS

CONTACT

(214) 645-5465; sahil.chilukuri@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Neurological Surgery

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 8, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)