Remediation of Impaired Self-Regulation in Patients With Mild TBI

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.

Timeline

Start

2015-08-01

Primary completion

2021-06-30

Completion

2021-06-30

Outcome

Met primary endpoint

registry analysis (superiority test); Tolcapone vs Placebo; p <0.0001; F value 24.1; ANOVA; note: This p-value is adjusted for multiple comparisons. NCT02260570 ↗

paper Subjects with more severe PTSD showed both greater tolcapone-mediated improvements in d' and larger tolcapone-mediated reductions in liberally-biased responding for fearful stimuli. PMID 34253715 ↗

registry analysis (superiority test); Tolcapone vs Placebo; p = 0.0184; F value 6.23; ANOVA; note: This p-value is adjusted for multiple comparisons. NCT02260570 ↗

Publications

• Results 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. doi: 10.1038/s41398-021-01512-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolcapone	Unknown	—	—

Indications