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Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

NCT04245124 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2021-02-03

No results posted yet for this study

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

Interventions

OTHER

Strategic Memory Advanced Reasoning Training

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

OTHER

Traditional Cognitive Rehabilitation

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)

Sponsors & Collaborators

  • The University of Texas at Dallas

    collaborator OTHER

  • The Defense and Veterans Brain Injury Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245124 on ClinicalTrials.gov