Action Regulation Behavioral

NCT ID: NCT06489483

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2027-11-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Parkinson's Disease Patients

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

Group Type: EXPERIMENTAL

Action Regulation Movement Task

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Action Regulation Movement Task

Intervention Type: 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.

Interventions

Action Regulation Movement Task

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• 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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Riverside

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nader Pouratian

Professor and Chair of Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nader Pouratian, MD, Phd

Role: CONTACT

nader.pouratian@utsouthwestern.edu

(214) 645-5465

Sahil Chilukuri, BS

Role: CONTACT

sahil.chilukuri@utsouthwestern.edu

(214) 645-5465

Facility Contacts

Sahil Chilukuri

Role: primary

sahil.chilukuri@utsouthwestern.edu

Nader Pouratian

Role: backup

nader.pouratian@utsouthwestern.edu

Other Identifiers

STU-2022-0555

Identifier Type: -

Identifier Source: org_study_id