NCT01640158

Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury

BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Posit Science Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

Detailed description

This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of plasticity-based, adaptive, computerized cognitive remediation treatment versus a computer-based control. Both the study and the cognitive remediation treatments meet the criteria of Non-Significant Risk.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Computerized Plasticity-based Adaptive Cognitive Training	Computerized plasticity-based adaptive cognitive training, up to 65 hours
OTHER	Commercially available computerized training	Commercially available computerized training, up to 65 hours

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-03-02
• Completion: 2017-03-02
• First posted: 2012-07-13
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States