Ignite Creation Date:
2024-05-06 @ 12:43 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01640158
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2012-07-10
Brief Title:
Broad-spectrum Cognitive Remediation Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
Sponsor:
Posit Science Corporation
Organization:
Posit Science Corporation
Study Overview
Official Title:
BRAVE Trial Broad-spectrum Cognitive Remediation Available to Veterans Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury mTBI
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAVE
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None