Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

NCT04245124 | Unknown

• 1 other identifier: NHCP.2020.0006
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Keywords

COGNITIVE REHABILITATION

Outcome Measures

Primary Outcomes (1)

• 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.

  4 MONTHS

Secondary Outcomes (2)

• Change in healthcare utilization

  4.5 MONTHS

• Change in level of occupational performance

  4.5 MONTHS

Study Arms (2)

SMART INTERVENTION

EXPERIMENTAL

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

Other: Strategic Memory Advanced Reasoning Training

TCR

EXPERIMENTAL

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

Other: Traditional Cognitive Rehabilitation

Interventions

Strategic Memory Advanced Reasoning Training OTHER

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

SMART INTERVENTION

Traditional Cognitive Rehabilitation OTHER

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)

TCR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Defense and Veterans Brain Injury Center: lead
• The University of Texas at Dallas: collaborator

Study Sites (1)

Naval Hospital Camp Pendleton

Oceanside, California, 92055, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Angela G Basham, MPH

CONTACT

7607194201; ANGELA.G.BASHAM.CTR@MAIL.MIL

MELISSA JENSEN

CONTACT

melissa.a.jensen16.ctr@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: January 28, 2020
• Study Start: February 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)