Remediation of Impaired Self-Regulation in Patients With Mild TBI
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/9/2019 |
| Start Date: | August 1, 2015 |
| End Date: | June 29, 2019 |
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.
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.
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).
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).
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;
- 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
We found this trial at
1
site
Sacramento, California 95655
Principal Investigator: Andrew S Kayser, MD PhD
Phone: 925-372-2059
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