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Remediation of Impaired Self-Regulation in Patients With Mild TBI

NCT02260570 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-09-22

Study results available
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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.

Conditions

  • Mild Traumatic Brain Injury

Interventions

DRUG

Tolcapone

COMT Inhibitor

DRUG

Placebo

A pill that contains no active ingredient

Sponsors & Collaborators

Principal Investigators

  • Andrew S Kayser, MD PhD · VA Northern California Health Care System, Mather, CA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260570 on ClinicalTrials.gov