Remediation of Impaired Self-Regulation in Patients With Mild TBI

Mild Traumatic Brain Injury Clinical Trial

Official title:

Remediation of Impaired Self-Regulation in Patients With Mild TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260570
• Other study ID #: D0825-I
• Secondary ID: 1I01RX000825-01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this randomized, double-blind, placebo-controlled, crossover cognitive neuroscience study, the investigators are evaluating whether the COMT inhibitor tolcapone impacts memory and self regulation, as measured both behaviorally (via cognitive testing) and neurophysiologically (via functional MRI). A new study arm that does not include use of tolcapone, nominally equivalent to the placebo arm only, is now also included to address performance on cognitive testing alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Drug:
• Tolcapone
COMT Inhibitor
• Placebo
A pill that contains no active ingredient

Locations

Country	Name	City	State
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of California, Berkeley, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Westphal AJ, Ballard ME, Rodriguez N, Vega TA, D'Esposito M, Kayser AS. Working memory, cortical dopamine tone, and frontoparietal brain recruitment in post-traumatic stress disorder: a randomized controlled trial. Transl Psychiatry. 2021 Jul 12;11(1):389 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen Level Dependent (BOLD) brain signal measured using functional MRI	BOLD signal provides an indirect measure of brain activity during cognitive testing	Approximately 60-240 minutes following tolcapone/placebo administration
Primary	Performance on Cognitive Testing	Tasks to assess cognition will be performed while subjects are in the MRI scanner	Approximately 60-240 minutes following tolcapone/placebo administration