Mild TBI Assessment & Rehabilitation

ID: NCT02920788
Status: Recruiting
Phase: N/A
Start Date: March 09, 2017
First Submitted: September 27, 2016
Last Updated: February 15, 2018
Results: N/A
Sponsors & Collaborators: VA Office of Research and Development
Location: United States
Conditions: Brain Injuries, Traumatic
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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.
Condition or disease Intervention/treatment Phase

Brain Injuries, Traumatic

Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS)
Other Names
Device: fMRI
Other Names
N/A

Tracking Information

First Submitted DateSeptember 27, 2016
Last Update Posted DateFebruary 15, 2018
Actual Start DateMarch 09, 2017
Anticipated Completion DateDecember 31, 2021
Actual Primary Completion DateJune 30, 2021
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleMild TBI Assessment & Rehabilitation
Official TitleMulti-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/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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
36
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Brain Injuries, Traumatic
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
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.

Other Names
Device: fMRI

Functional Magnetic Resonance Imaging of the Brain

Other Names
Study Groups/Cohorts
Veteran Mild TBI Group - GOALS Intervention
Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.

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.

Study Arms
Experimental Veteran Mild TBI Group - GOALS Intervention
Veterans ages 18+ 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.

Experimental Veteran Mild TBI Group - GOALS Intervention
Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.
Device : fMRI
Functional Magnetic Resonance Imaging of the Brain

Arm Intervention/Treatment
Experimental Veteran Mild TBI Group - GOALS Intervention
Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.
Behavioral : Goal-Oriented Attentional Self-Regulation (GOALS)
Experimental Veteran Mild TBI Group - GOALS Intervention
Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.
Device : fMRI

Recruitment Information

Recruitment Status:Recruiting
Enrollment36
Completion DateDecember 31, 2021
Eligibility 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02920788
Other Study ID Numbers
N2300-R
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
VA Office of Research and Development
Collaborators
Not Available
Investigators
Principal Investigator
Pratik Mukherjee, MD PhD
San Francisco VA Medical Center, San Francisco, CA