Parkinson DiseaseNCT06489483
Action Regulation Behavioral
A study testing Action Regulation Movement Task in people with Parkinson Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Action Regulation Movement Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Sahil Chilukuri, sahil.chilukuri@utsouthwestern.edu
Nader Pouratian, nader.pouratian@utsouthwestern.edu
About this study
Official title: Revealing the Action Regulation Mechanisms in the Human Brain
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
- Being tested
- Action Regulation Movement Task
- Keywords
- Levodopa medication, motor cortex, basal ganglia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Regulation Movement TaskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Action Regulation Movement Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop-Signal Task
Each patient will complete a joystick-based stop-signal task which assesses reaction time, stop reaction time, accuracy, and joystick traces.
Measured: Baseline
Switch Task
Each patient will complete a joystick-based switch task which assess reaction time, switch reaction time, accuracy, and joystick traces.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start24 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside
- Responsible party
- Principal investigator, Nader Pouratian, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489483
- Sponsor's protocol ID
- STU-2022-0555
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following data acquisition, de-identified data will be shared with research team at University of California, Riverside.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing the Action Regulation Mechanisms in the Human Brain
- ClinicalTrials.gov ID
- NCT06489483
- Acronym / sponsor ID
- STU-2022-0555
- Conditions
- Parkinson Disease
- Keywords
- Levodopa medication, motor cortex, basal ganglia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Riverside
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Patients | Experimental | Behavioral: Action Regulation Movement TaskPatients that have been diagnosed with Parkinson's Disease and are responsive to levodopa medication. Patients will complete a behavioral task. |
| Healthy Controls | Active comparator | Behavioral: Action Regulation Movement TaskMen 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Regulation Movement TaskA 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. | Behavioural | Healthy Controls, Parkinson's Disease Patients |
Primary outcome
Stop-Signal Task
Time frame: Baseline
Each patient will complete a joystick-based stop-signal task which assesses reaction time, stop reaction time, accuracy, and joystick traces.
Switch Task
Time frame: Baseline
Each patient will complete a joystick-based switch task which assess reaction time, switch reaction time, accuracy, and joystick traces.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. Following data acquisition, de-identified data will be shared with research team at University of California, Riverside.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Regulation Movement Task in people with Parkinson Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nader Pouratian, MD, Phd ((214) 645-5465, nader.pouratian@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop-Signal Task (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.