NCT06671626Enrolling by invitation
Intracranial Recordings to Characterize Action Regulation Mechanisms
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- First submitted
- 31 Oct 2024
- Start date
- 13 Mar 2025
- Primary completion date
- Jun 2029
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT06671626
What you commit to
- Study type: Interventional
- Planned participants: 125
- From 13 Mar 2025 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients with recent use (within one week) of anticoagulant or antiplatelet agent use.
- Neurocognitive testing indicating amnestic cognitive deficits (MOCA \< 24).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.