Clinical trial NCT01640158: Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
Official title: BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: mild Traumatic Brain Injury
Cognitive remediation
computer
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: Congressionally Directed Medical Research Programs
name: Walter Reed National Military Medical Center
name: Tripler Army Medical Center
name: VA Connecticut Healthcare System
name: VA Boston Healthcare System
name: Michael E. DeBakey VA Medical Center
First posted: 2012-07-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be 18 - 50 years of age at the time of consent
2. Subjects must have a diagnosis of mTBI
3. 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).
4. 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.
5. Subjects must be fluent English speakers.
6. Subjects must have adequate sensorimotor capacity to perform the program in the judgment of the consenting clinician.

Exclusion Criteria:

1. Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
2. Subjects must not be in-patients.
3. Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
4. Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
5. Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
6. Subjects must not have clinically significant visual field deficits noted by the consenting staff member by direct observation or by medical history.
7. Subjects must not be judged to be lacking effort.
8. Subjects must not have problems performing assessments or comprehending or following spoken instructions.
9. 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.

Primary outcomes:
measure: Change in Cognitive Function
timeFrame: After three months of training
measure: Change in Functional Performance
timeFrame: After three months of training
Secondary outcomes:
measure: Change in Mental Health-Related Quality of Life
timeFrame: After three months of training and 3 months after training completion
measure: Change in Physical Health-Related Quality of Life
timeFrame: After three months of training and 3 months after training completion
measure: Change in Depressive Symptoms
timeFrame: After three months of training and 3 months after training completion
measure: Change in PTSD Symptoms
timeFrame: After three months of training and 3 months after training completion
measure: Change in Executive Function Symptoms
timeFrame: After three months of training and 3 months after training completion
measure: Change in Cognitive Symptoms
timeFrame: After three months of training and 3 months after training completion
measure: Change in Neurobehavioral Symptoms
timeFrame: After three months of training and 3 months after training completion
measure: Change in TBI Functional Status
timeFrame: After three months of training and 3 months after training completion
measure: Change in Immediate Verbal Memory
timeFrame: After three months of training and 3 months after training completion
measure: Change in Delayed Verbal Memory
timeFrame: After three months of training and 3 months after training completion
measure: Change in Immediate Visual Memory
timeFrame: After three months of training and 3 months after training completion
measure: Change in Delayed Visual Memory
timeFrame: After three months of training and 3 months after training completion
measure: Change in Short-Term Verbal Memory Span
timeFrame: After three months of training and 3 months after training completion
measure: Change in Short-Term Visual Memory Span
timeFrame: After three months of training and 3 months after training completion
measure: Change in Inhibition of Reflexive Saccade
timeFrame: After three months of training and 3 months after training completion
measure: Change in Response Inhibition
timeFrame: After three months of training and 3 months after training completion
measure: Change in Cognitive Flexibility
timeFrame: After three months of training and 3 months after training completion
measure: Change in Functional Performance
timeFrame: 3 months after training completion
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Henry W Mahncke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Posit Science Corporation
name: Cate N Stasio, BA
role: STUDY_DIRECTOR
References:
citation: Consensus conference. Rehabilitation of persons with traumatic brain injury. NIH Consensus Development Panel on Rehabilitation of Persons With Traumatic Brain Injury. JAMA. 1999 Sep 8;282(10):974-83.