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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Congressionally Directed Medical Research Programs
Walter Reed National Military Medical Center
Tripler Army Medical Center
VA Connecticut Healthcare System
VA Boston Healthcare System
Michael Debakey Veterans Affairs Medical Center
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT01640158
First received: July 10, 2012
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Traumatic Brain Injury
Other: Computerized Plasticity-based Adaptive Cognitive Training
Other: Commercially available computerized training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)

Resource links provided by NLM:


Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • Verbal Learning and Memory [ Time Frame: 6 months post ]
    Between-group magnitude of change in verbal learning and memory utilizing the Rey Auditory Verbal Learning Test (RAVLT).


Secondary Outcome Measures:
  • Executive Function [ Time Frame: 6 Months ]
    Between-group magnitude of change in executive function as measured by the Executive Abilities Methods and Instruments for Neurobehavioral Research (EXAMINER) assessment.


Enrollment: 86
Study Start Date: September 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Treatment
Computerized plasticity-based adaptive cognitive training, up to 65 hours
Other: Computerized Plasticity-based Adaptive Cognitive Training
Computerized plasticity-based adaptive cognitive training, up to 65 hours
Active Comparator: Active Comparator
Commercially available computerized training, up to 65 hours
Other: Commercially available computerized training
Commercially available computerized training, up to 65 hours

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640158

Locations
United States, California
Posit Science Corporation
San Francisco, California, United States, 94108
Sponsors and Collaborators
Posit Science Corporation
Congressionally Directed Medical Research Programs
Walter Reed National Military Medical Center
Tripler Army Medical Center
VA Connecticut Healthcare System
VA Boston Healthcare System
Michael Debakey Veterans Affairs Medical Center
Investigators
Principal Investigator: Henry W Mahncke, PhD Posit Science Corporation
Study Director: Cate N Stasio, BA Posit Science Corporation
  More Information

Publications:
Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT01640158     History of Changes
Other Study ID Numbers: BPI-1002-11
Study First Received: July 10, 2012
Last Updated: January 24, 2017

Keywords provided by Posit Science Corporation:
mild Traumatic Brain Injury
Cognitive remediation
computer

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on March 22, 2017