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The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

NCT01339806 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2015-02-09

No results posted yet for this study

Summary

The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24 months post injury) cognitive complaints. This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks following the initiation of the study. The total number of patients to be studied is 160 (maximum), which is approximately 20 patients per month.

Conditions

  • Traumatic Brain Injury With Brief Loss of Consciousness
  • Traumatic Brain Injury With No Loss of Consciousness

Interventions

BEHAVIORAL

Cognitive Rehab

APT-III, Other standard individual and group interventions.

BEHAVIORAL

Brainworks

POSIT

BEHAVIORAL

Informational Handout/Provider Visits

Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.

Sponsors & Collaborators

  • The Defense and Veterans Brain Injury Center

    collaborator FED

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    collaborator OTHER

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Amy O Bowles, MD · BAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-06-30
Completion
2014-08-31

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 NCT01339806 on ClinicalTrials.gov