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Completed

NCT Number: NCT01640158

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Posit Science Corporation

San Francisco, California, 94108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

Computerized plasticity-based adaptive cognitive training, up to 65 hours

Commercially available computerized training

Other

Commercially available computerized training, up to 65 hours

Primary outcomes

  1. Change in Cognitive Function

    Time frame: After three months of training

    Between-group magnitude of change in composite score with the measure constructed from Rey Auditory Verbal Learning Test (RAVLT) sum of trials 1-5 (immediate verbal memory), RAVLT delayed verbal recall, the Ruff Light Trails Test (RULIT) sum of trials 2-10 (immediate visual memory), RULIT delayed recall scores, digit span (WAIS, sum of forwards, backwards, sequencing), symbol span (WMS), anti-saccades, flanker, and set-shifting (each from the EXAMINER battery).

  2. Change in Functional Performance

    Time frame: After three months of training

    Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.

Secondary outcomes

  1. Change in Mental Health-Related Quality of Life

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in the Mental Component Score (MCS) as measured by the SF-12v2 Health Survey. The component score is a normed-based score with a mean of 50. Scores less than 50 indicate worse mental health than the mean.

  2. Change in Physical Health-Related Quality of Life

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in the Physical Component Score (PCS) as measured by the SF-12v2 Health Survey. The component score is a normed-based score with a mean of 50. Scores less than 50 indicate worse physical health than the mean.

  3. Change in Depressive Symptoms

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in sum score using the self-report measure, Beck Depression Inventory (BDI-II). The scoring range is 0-63. Higher scores indicate more severe depressive symptoms.

  4. Change in PTSD Symptoms

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in sum score using the self-report measure, PTSD Checklist - Civilian Version (PCL-C). The scoring range is 17-85. Higher scores indicate more severe PTSD symptoms.

  5. Change in Executive Function Symptoms

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in After total T-score using the self-report measure, Frontal Systems Behavior Scale (FrSBe). Raw scores are converted to age- and education-corrected T-scores. The mean T-score is 50, scores greater than 65 are considered clinically significant.

  6. Change in Cognitive Symptoms

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in sum score using the self-report measure, Cognitive Failures Questionnaire (CFQ). The scoring range is 0-100. Higher scores indicate more severe cognitive symptoms.

  7. Change in Neurobehavioral Symptoms

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in sum score using the self-report measure, Neurobehavioral Symptoms Index (NSI). The scoring range is 0-88. Higher scores indicate more severe neurobehavioral symptoms.

  8. Change in TBI Functional Status

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status.

  9. Change in Immediate Verbal Memory

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in sum of Trials 1-5 of the Rey Auditory Verbal Learning Test (RAVLT). The scoring range is 0-75. Lower scores indicate greater impairment in immediate verbal memory.

  10. Change in Delayed Verbal Memory

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in total score of delayed verbal recall on the Rey Auditory Verbal Learning Test (RAVLT). The scoring range is 0-15. Lower scores indicate greater impairment in delayed verbal memory.

  11. Change in Immediate Visual Memory

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in sum of Trials 2-10 of the Ruff Light Trails Test (RULIT). The scoring range is 0-135. Lower scores indicate greater impairment in immediate visual memory.

  12. Change in Delayed Visual Memory

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in total score of delayed visual recall on the Ruff Light Trails Test (RULIT). The scoring range is 0-15. Lower scores indicate greater impairment in delayed visual memory.

  13. Change in Short-Term Verbal Memory Span

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in sum of forwards, backwards, and sequencing tasks of the Wechsler Adult Intelligence Scale (WAIS) 4th Edition - Digit Span. The scoring range is 0-48. Lower scores indicate greater impairment in short-term verbal memory.

  14. Change in Short-Term Visual Memory Span

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in total score of the Wechsler Memory Scale (WMS) 4th Edition - Symbol Span. The scoring range is 0-50. Lower scores indicate greater impairment in short-term visual memory.

  15. Change in Inhibition of Reflexive Saccade

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in total score of the Anti-Saccade task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-40. Lower scores indicate greater impairment in reflexive saccade inhibition.

  16. Change in Response Inhibition

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in total score of the Flanker task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-10. Lower scores indicate greater impairment in response inhibition.

  17. Change in Cognitive Flexibility

    Time frame: After three months of training and 3 months after training completion

    Between-group magnitude of change in total score of the Set-Shifting task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-10. Lower scores indicate greater impairment in mental flexibility.

  18. Change in Functional Performance

    Time frame: 3 months after training completion

    Between-group magnitude of change in sum score of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • Congressionally Directed Medical Research Programs
  • Michael E. DeBakey VA Medical Center
  • Tripler Army Medical Center
  • VA Boston Healthcare System
  • VA Connecticut Healthcare System
  • Walter Reed National Military Medical Center

Registry information

Official study title

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

Acronym: BRAVE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2012
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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