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Mild TBI Assessment & Rehabilitation (MTAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920788
Recruitment Status : Active, not recruiting
First Posted : September 30, 2016
Last Update Posted : October 7, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE September 30, 2016
Last Update Posted Date October 7, 2022
Actual Study Start Date  ICMJE March 9, 2017
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2016)
Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task [ Time Frame: 6 months after enrollment ]
Single Test for Attention, Executive Function and Mental Flexibility
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mild TBI Assessment & Rehabilitation
Official Title  ICMJE Multi-Level Assessment and Rehabilitation of Combat Mild TBI
Brief Summary One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.
Detailed Description

Combat-related mild traumatic brain injury (mTBI) and co-morbid conditions are prevalent in returning Veterans with the reported rates ranging from 14- 22%. Chronic sequela of mTBI can be highly debilitating due to deficits in the cognitive control processes, including attention, executive functions, and memory. In prior studies, individuals with chronic acquired brain injury who participated in a cognitive training program, Goal-Oriented Attentional Self-Regulation (GOALS), which targets executive control functions of applied mindfulness-based attention regulation and goal management, improved cognitive performance in areas of: complex attention/executive function and memory, complex functional task performance, and daily functioning. Furthermore, functional MRI (fMRI) results after training indicated significantly enhanced modulation of neural processing. Preliminary data from recently completed randomized-control GOALS study in 32 Veterans with chronic TBI also show both short and longer term (up to 2 years) improvements in attention and executive function, complex real-life tasks, and emotional regulation.

The primary objectives of this study are to investigate the potential short and longer term effects of GOALS cognitive training program, and to use advanced MRI to investigate changes in brain structure and function in the circuits that regulate attention, memory, executive function and emotion in Veterans with chronic mTBI.

The investigators postulate that 1) GOALS training will improve neurocognitive function in attention and executive function domains, complex functional task performance, and emotional regulation in Veterans with chronic mTBI; 2) improved neurocognitive function will be correlated with macrostructural, microstructural and functional changes in the corresponding brain networks on high field (3T) and ultra-high field (7T) structural MR imaging, diffusion tensor imaging (DTI) and resting state fMRI performed pre- and post-training; 3) Changes in both behavioral function and imaging measures will be maintained at 6 months post-training and be associated with improvements in activities and participation.

AIM 1: To determine the short and long term effects of GOALS training on neuro-cognitive performance and neural plasticity of attention and executive control networks in mTBI.

AIM 2: To determine the short and long term effects of GOALS training on complex functional task performance and daily functioning, and on plasticity in pathways related to memory function, in mTBI.

AIM 3: To determine the short and long term effects of GOALS training on measures of emotional regulation, and on plasticity of frontolimbic networks related to emotion processing, in mTBI In a randomized, controlled interventional study design, 36 Veterans with a history of chronic (> 6 month) mTBI and residual cognitive difficulties will be randomized to participate in 5 weeks of cognitive training (GOALS) or a treatment as usual (TAU) comparison. At baseline, week 5 (post GOALS), and at 6 months, participants will undergo a multi-level assessment battery consisting of: 1) neuroimaging with high field (3T) and ultra-high field (7T) structural MR imaging, diffusion tensor imaging (DTI) and resting state fMRI; 2) neuropsychological assessment focusing on complex attention and executive function; 3) complex 'real life' functional task performance; and 4) self-report measures of daily functioning and emotional regulation/health.

Additionally, the investigators will be recruiting a separate cohort of 15 equally matched healthy veteran volunteers who have no TBI history, for normative comparisons. TBI-negative participants, who will not be participating in training sessions, will have neuroimaging with ultra-high field (7T) structural MR imaging and neuropsychological assessments at baseline and week 5.

When completed, this project will determine whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving quality of life and daily functioning for Veterans with mTBI. The study design will provide a test of potential benefits on real-life functioning, and also determine to what extent these benefits are related to actual changes in hypothetically targeted cognitive/behavioral functions and brain networks corresponding to these functions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Injuries, Traumatic
Intervention  ICMJE
  • Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS)
    GOALS is a manualized, therapist-administered cognitive training program that targets executive control functions of applied mindfulness-based attention regulation and goal management strategies and links them to participant-defined real-life goals. In contrast to training via practice on isolated tasks, this training protocol involves application of attention regulation skills and strategies to participant-defined goals in real life, ecologically valid settings. One of the main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment.
  • Other: Brain Health Education (BHE)
    BHE group is a formal in-person, active, psycho-educational, control intervention closely matched to GOALS for length, intensity, and contact with a therapist/facilitator. Topics include brain structure, function, sleep, stress, emotion and the brain.
    Other Name: Treatment As Usual (TAU)
  • Device: fMRI
    Functional Magnetic Resonance Imaging of the Brain
Study Arms  ICMJE
  • Experimental: Veteran Mild TBI Group - GOALS Intervention
    Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.
    Interventions:
    • Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS)
    • Device: fMRI
  • Active Comparator: Veteran Mild TBI - Treatment as Usual
    Veterans ages 18+ with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care.
    Interventions:
    • Other: Brain Health Education (BHE)
    • Device: fMRI
  • No Intervention: Veteran Non TBI - No Treatment
    Veterans ages 18+ with no history of TBI, to undergo Neuropsychologic evaluation and MR Imaging with no intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 6, 2022)
57
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2016)
36
Estimated Study Completion Date  ICMJE March 31, 2023
Actual Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

For TBI-positive veteran participants, to be randomized to either GOALS or TAU:

  • Ages 18+
  • A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
  • Chronic, stable phase of recovery (>6 months from last post-concussive event)
  • Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function
  • Able and willing to commit to participate in training and assessments
  • If on psychoactive medications, must be stable on medications (> 30 days)

For the TBI-negative healthy veteran control group:

  • Ages 18+
  • No history of any (mild to severe) TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
  • Able and willing to commit to participate in assessments
  • If on psychoactive medications, must be stable on medications (> 30 days)

Exclusion Criteria:

For the TBI-positive veteran participants, to be randomized to either GOALS or TAU:

  • A history of moderate or severe TBI
  • Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI)
  • Ongoing illicit drug or alcohol abuse (AUDIT>8)
  • Psychosis
  • Severe depression, anxiety or PTSD that precludes participation in research activities
  • Poor English comprehension
  • Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD
  • There will be no restriction in regard to gender, race and socioeconomic status

For the TBI-negative healthy veteran control group:

  • A history of any mild, moderate, or severe TBI
  • Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g. contraindications to MRI)
  • Ongoing illicit drug or alcohol abuse (AUDIT>8)
  • Psychosis
  • Severe depression, anxiety or PTSD that precludes participation in research activities
  • Poor English comprehension
  • Eligible participants may have other co-morbid stable neuropscyhiatric disorders, including depression and PTSD.
  • There will be no restriction in regard to gender, race and socioeconomic status
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02920788
Other Study ID Numbers  ICMJE N2300-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party VA Office of Research and Development
Original Responsible Party Same as current
Current Study Sponsor  ICMJE VA Office of Research and Development
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pratik Mukherjee, MD PhD San Francisco VA Medical Center, San Francisco, CA
PRS Account VA Office of Research and Development
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP