NCT02260570

Remediation of Impaired Self-Regulation in Patients With Mild TBI

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 impacts memory and self regulation, as measured both behaviorally (via cognitive testing) and neurophysiologically (via functional MRI).

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Tolcapone	COMT Inhibitor
DRUG	Placebo	A pill that contains no active ingredient

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2014-10-09
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study