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History of Changes for Study: NCT02920788
Mild TBI Assessment & Rehabilitation (MTAR)
Latest version (submitted October 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 28, 2016 None (earliest Version on record)
2 October 4, 2016 Study Status and Conditions
3 April 11, 2017 Recruitment Status, Study Status, Contacts/Locations, Study Design, Oversight and Eligibility
4 April 14, 2017 Study Design and Study Status
5 May 5, 2017 Study Status and Contacts/Locations
6 September 13, 2017 Study Status, Contacts/Locations and Arms and Interventions
7 February 15, 2018 Study Status
8 August 3, 2018 Study Status
9 January 9, 2019 Study Status
10 June 25, 2019 Arms and Interventions, Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
11 November 29, 2019 Study Status and Study Description
12 April 29, 2020 Study Status
13 May 4, 2020 Study Status and Study Description
14 October 9, 2020 Study Status and Study Design
15 March 9, 2021 Study Status and Study Description
16 July 13, 2021 Study Status
17 November 2, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
18 March 7, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
19 October 6, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02920788
Submitted Date:  September 28, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: N2300-R
Brief Title: Mild TBI Assessment & Rehabilitation (MTAR)
Official Title: Multi-Level Assessment and Rehabilitation of Combat Mild TBI
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Not yet recruiting
Study Start: January 2017
Primary Completion: June 2021 [Anticipated]
Study Completion: December 2021 [Anticipated]
First Submitted: September 27, 2016
First Submitted that
Met QC Criteria:
September 28, 2016
First Posted: September 30, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 28, 2016
Last Update Posted: September 30, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: VA Office of Research and Development
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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/heath.

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.

Open or close this module Conditions
Conditions: Mild Traumatic Brain Injury
Keywords: Rehabilitation
Functional Magnetic Resonance Imaging
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Early Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Veteran Mild TBI Group - GOALS Intervention
Veterans ages 18 to 65 with chronic mild TBI, to undergo GOALS cognitive training as an intervention.
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 main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment.
Device: fMRI
Functional Magnetic Resonance Imaging of the Brain
No Intervention: Veteran Mild TBI - Treatment as Usual
Veterans ages 18 to 65 with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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
  • On stable psychoactive medications (> 30 days)

Exclusion Criteria:

  • 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 precluding 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
Open or close this module Contacts/Locations
Central Contact Person: Pratik Mukherjee, MD PhD
Email: pratik.mukherjee@va.gov
Central Contact Backup: Tatjana Novakovic-Agopian, PhD
Telephone: (415) 753-3888
Email: tatjana.novakovic-agopian@va.gov
Study Officials: Pratik Mukherjee, MD PhD
Principal Investigator
San Francisco VA Medical Center, San Francisco, CA
Locations: United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Contact:Contact: Pratik Mukherjee, MD PhD pratik.mukherjee@va.gov
Contact:Principal Investigator: Pratik Mukherjee, MD PhD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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