Status:
COMPLETED
Remediation of Impaired Self-Regulation in Patients With Mild TBI
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of California, Berkeley
University of California, San Francisco
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
The ability to regulate impulses enables us to plan for the future, to maintain focus in the face of distractions (i.e. to encode memories), and to manage emotions. This self regulation can be comprom...
Detailed Description
In this randomized, double-blind, placebo-controlled, crossover cognitive neuroscience study, the investigators are evaluating whether the catechol-O-methyltransferase (COMT) inhibitor tolcapone impac...
Eligibility Criteria
Inclusion
- Veteran ages 18-50 and in general good health;
- Able to read English at a 6th grade level;
- Able to provide written informed consent;
- Normal or corrected to normal visual acuity;
- Stable doses of all medications (2 weeks or greater);
- History of mild traumatic brain injury greater than 6 months prior to participation
Exclusion
- Contraindications to magnetic resonance imaging (MRI) scanning;
- Inability to complete basic fMRI requirements;
- History of brain surgery or penetrating brain injury;
- Uncontrolled blood pressure (low or high);
- Contraindications to tolcapone use;
- Use of medications or drugs with dopamine-related actions within 30 days;
- Active substance abuse or dependence;
- Clinically severe medical illness requiring treatment;
- History of psychiatric hospitalization (past 1 year) or suicide attempt (past 5 years);
- Seizures greater than 4 weeks after traumatic brain injury (TBI) event or seizures requiring active treatment;
- History of brain tumor, stroke, Alzheimer's disease, aneurysm rupture, or multiple sclerosis;
- History of schizophrenia, attention deficit hyperactivity disorder (ADHD) or psychiatric diagnosis EXCEPT depression or post-traumatic stress disorder (PTSD)
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02260570
Start Date
August 1 2015
End Date
June 30 2021
Last Update
September 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655