Remediation of Impaired Self-Regulation in Patients With Mild TBI

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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 compromised in individuals who have a history of mild traumatic brain injury and co-occurring disorders. In this study the investigators are using functional MRI scanning to understand how memory and self regulation are expressed in the brains of people with a history of mild traumatic brain injury. The investigators are also testing whether the medication tolcapone may improve memory and self regulation.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborators: University of California, Berkeley; University of California, San Francisco
• Treatments: Tolcapone

Criteria

Inclusion Criteria:

• 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 Criteria:

• Contraindications to 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 (not required for subjects who participate only in the study arm that does not include study medication);

• 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 TBI event or seizures requiring active treatment;

• History of brain tumor, stroke, Alzheimer's disease, aneurysm rupture, or multiple sclerosis;

• History of schizophrenia, ADHD or psychiatric diagnosis EXCEPT depression or PTSD