Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
This trial is active, not recruiting.
|Condition||traumatic brain injury|
|Treatments||computerized plasticity-based adaptive cognitive training, commercially available computerized training|
|Sponsor||Posit Science Corporation|
|Collaborator||Congressionally Directed Medical Research Programs|
|Start date||September 2013|
|End date||February 2017|
|Trial size||86 participants|
|Trial identifier||NCT01640158, BPI-1002-11|
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.
|Intervention model||parallel assignment|
|Masking||participant, care provider, investigator, outcomes assessor|
Verbal Learning and Memory
time frame: 6 months post
time frame: 6 Months
All participants from 18 years up to 50 years old.
- Subjects must be 18 - 50 years of age at the time of consent
- Subjects must have a diagnosis of mTBI
- Subjects must have persistent cognitive dysfunction confirmed by an objective measure (as recommended by the ICD-10 definition for post-concussion syndrome) or a subjective measure (as recommended by the DSV-IV definition of post-concussional disorder).
- Subjects must be at least three months out from their most recent TBI, concussion, and/or blast exposure to minimize the effects of spontaneous recovery, as verified through participant interview.
- Subjects must be fluent English speakers.
- Subjects must have adequate sensorimotor capacity to perform the program in the judgment of the consenting clinician.
- Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
- Subjects must not be in-patients.
- Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
- Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
- Subjects must not have clinically significant visual field deficits noted by the consenting staff member by direct observation or by medical history.
- Subjects must not be judged to be lacking effort.
- Subjects must not have problems performing assessments or comprehending or following spoken instructions.
- Subjects must not be enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study.
|Official title||BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)|
|Principal investigator||Henry W Mahncke, PhD|
|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.|
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