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Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury (VoCET-mTBI)

Primary Purpose

Mild Traumatic Brain Injury

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Strategic Memory Advanced Reasoning Training

Traditional Cognitive Rehabilitation

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring COGNITIVE REHABILITATION

Eligibility Criteria

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Inclusion Criteria:

• Male or female ages 18 years or older
- Active duty military personnel
- History of mTBI: participants will have a history of at least one mTBI sustained >3 months previously based on criteria of the DoD diagnostic criteria (Department of Veterans Affairs and Department of Defense, 2016). This specifies an external force to the head which resulted in physiological dysfunction of the brain as manifested by one or more of the following acute symptoms:
  1. Any loss of consciousness (not to exceed 30 minutes)
  2. Any loss of memory for the events immediately before or after the injury (not to exceed 1 day)
  3. Any alteration of consciousness or change in mental state (not to exceed 24 hours)
- Persistent Post-Concussive Symptoms: Participants will endorse elevated neurobehavioral symptomatology compared to published normative data (Soble et al. 2014), with at least one cognitive symptom (e.g., a score of 3 or greater on at least one of the four items on the NSI cognitive domain).

Exclusion Criteria:

• History of TBI (any severity) within 3 months of enrollment.
- History of moderate, severe, or penetrating TBI as defined by DOD/VA guidelines during their lifetime
- Current substance use disorder based on patient self-report.
- History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder.
- Current, active suicidal or homicidal ideation.
- Impaired decision-making capacity.

Sites / Locations

Naval Hospital Camp PendletonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SMART INTERVENTION

TCR

Arm Description

N= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION

N= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION

Outcomes

Primary Outcome Measures

Change in cognitive impairment

Cognitive impairment will be measured using the Global Deficit Score (GDS) which allows for the detection of subtle and varied degree of impairment from multiple measures.

Secondary Outcome Measures

Change in healthcare utilization

Healthcare utilization post-treatment, as measured by the number of medical appointments to rehabilitation specialists.

Change in level of occupational performance

Ratings of occupational performance by a direct supervisor using a modified Checklist of Military Activities of Daily Living (M-ADL).

Full Information

NCT ID

NCT04245124

First Posted

November 8, 2019

Last Updated

February 1, 2021

Sponsor

The Defense and Veterans Brain Injury Center

Collaborators

The University of Texas at Dallas

1. Study Identification

Unique Protocol Identification Number

NCT04245124

Brief Title

Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

Acronym

VoCET-mTBI

Official Title

Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Anticipated)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Defense and Veterans Brain Injury Center

Collaborators

The University of Texas at Dallas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

With an average of 21,000 diagnosed brain injuries each year among military personnel, traumatic brain injury (TBI) remains a major health concern for the United States Military Health System. Mild traumatic brain injury (mTBI) is the most common type of brain injury sustained by military personnel and may result in chronic cognitive impairment.Unfortunately, many service members (SMs) have a history of multiple head injuries as well as psychological co-morbidities that negatively influence recovery. Advances in treatment options for cognitive rehabilitation following mTBI have been of increasing interest to the medical community and may increase treatment efficacy for injured SMs to ensure force readiness. Cognitive Rehabilitation (CR) for severe brain injury focuses on compensatory strategies for activities of daily living such as using lists to remember grocery items or reminders to take medications and attend medical appointments. Research has shown CR interventions to have considerable effectiveness in the acute and sub-acute phase of recovery after severe TBI. But there is insufficient evidence that they improve rates of individuals returning to work, independence in activities of daily living (ADL), community re-integration, or quality of life.

Detailed Description

Cognitive Rehabilitation for mild brain injury has shown some modest evidence of effectiveness. CR interventions for mTBI typically focus on compensating for subjective and functional cognitive complaints. A number of recent studies have examined the use of compensatory CR approaches for individuals (primarily military veterans) diagnosed with mild cognitive impairment from a likely mTBI. These interventions taught individuals adaptive functional skills (e.g., cognitive mnemonics) and highlighted use of external aids such as smart phone scheduling/reminder applications. A randomized control trial that included 16 veterans with TBI (mixed mild and moderate severity), found this compensatory CR intervention was effective at reducing overall symptoms, but did not impact cognitive performance or work-outcomes. In a secondary study, there was some evidence that the compensatory CR intervention improved memory at 6 months post-treatment and quality of life at 12 months but there was not a consistent pattern of improvement compared to controls. Generalizability from civilian and veteran communities to active duty SMs may pose some unique and unexplored factors as the goal of treatment is not remediation of common activities of daily living (e.g., remembering appointments) but in contrast, the goal is military readiness needed for worldwide deployability to potential wartime environments (e.g., "cognitive readiness").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Traumatic Brain Injury

Keywords

COGNITIVE REHABILITATION

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Primary Aim: Difference in Cognitive and Neurophysiological Function between SMART and TCR. Multilevel mixed-effect modeling will be conducted for Aim 1 with treatment modality (SMART vs. TCR) as the independent variable. This approach will take into consideration between-subject variance based on randomized group, as well as within-subject variance for repeated measures. Primary analyses will be based on intention to treat, and we will leverage the statistical power of multilevel modeling to handle missing follow-up data. Outcome will be assessed as change in GDS over time. A significant p-value of 0.05 will be used to assess the main effects.

Masking

Participant

Allocation

Randomized

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SMART INTERVENTION

Arm Type

Experimental

Arm Description

N= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION

Arm Title

TCR

Arm Type

Experimental

Arm Description

N= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION

Intervention Type

Other

Intervention Name(s)

Strategic Memory Advanced Reasoning Training

Intervention Description

SMART focuses on three metacognitive strategies: Strategic Attention, Integrated Reasoning and Innovation.

Intervention Type

Other

Intervention Name(s)

Traditional Cognitive Rehabilitation

Intervention Description

Participants randomized to the TCR condition will participate in a clinician-directed intervention that provides manualized, traditional clinician-directed cognitive rehabilitation that was developed for the SCORE trial (Cooper et al., 2017)

Primary Outcome Measure Information:

Title

Change in cognitive impairment

Description

Cognitive impairment will be measured using the Global Deficit Score (GDS) which allows for the detection of subtle and varied degree of impairment from multiple measures.

Time Frame

4 MONTHS

Secondary Outcome Measure Information:

Title

Change in healthcare utilization

Description

Healthcare utilization post-treatment, as measured by the number of medical appointments to rehabilitation specialists.

Time Frame

4.5 MONTHS

Title

Change in level of occupational performance

Description

Ratings of occupational performance by a direct supervisor using a modified Checklist of Military Activities of Daily Living (M-ADL).

Time Frame

4.5 MONTHS

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Male or female ages 18 years or older Active duty military personnel History of mTBI: participants will have a history of at least one mTBI sustained >3 months previously based on criteria of the DoD diagnostic criteria (Department of Veterans Affairs and Department of Defense, 2016). This specifies an external force to the head which resulted in physiological dysfunction of the brain as manifested by one or more of the following acute symptoms: Any loss of consciousness (not to exceed 30 minutes) Any loss of memory for the events immediately before or after the injury (not to exceed 1 day) Any alteration of consciousness or change in mental state (not to exceed 24 hours) Persistent Post-Concussive Symptoms: Participants will endorse elevated neurobehavioral symptomatology compared to published normative data (Soble et al. 2014), with at least one cognitive symptom (e.g., a score of 3 or greater on at least one of the four items on the NSI cognitive domain). Exclusion Criteria: • History of TBI (any severity) within 3 months of enrollment. History of moderate, severe, or penetrating TBI as defined by DOD/VA guidelines during their lifetime Current substance use disorder based on patient self-report. History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder. Current, active suicidal or homicidal ideation. Impaired decision-making capacity.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Angela G Basham, MPH

Phone

7607194201

ANGELA.G.BASHAM.CTR@MAIL.MIL

First Name & Middle Initial & Last Name or Official Title & Degree

MELISSA JENSEN

melissa.a.jensen16.ctr@mail.mil

Facility Information:

Facility Name

Naval Hospital Camp Pendleton

City

Oceanside

State/Province

California

ZIP/Postal Code

92055

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angela Basham

Angela.g.basham.ctr@mail.mil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

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