CompletedPhase 4

The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

United States143 participantsStarted 2011-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of mTBI as defined in the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009) which occurred during deployment in support of OEF/OIF within 3-24 months of study enrollment; * Presence of cognitive complaints (NSI score of 3 or higher on any of the four cognitive symptoms) * Ability to understand and communicate in English. Exclusion Criteria: * Medical/psychiatric/neurologic co-morbidities of: blindness/low vision; uncontrolled seizure disorder; psychosis; history of moderate, severe TBI or penetrating BI; or Spinal Cord Injury with no use of upper extremities; * Active participation in intensive (\> 5 appointments per week) treatment for amputation, orthopedic trauma, burns, substance abuse, or post-traumatic stress disorder which would preclude full participation in an intensive cognitive rehabilitation program; or * Daily use of narcotic pain medication(s).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Emotional Functioning

Timeframe: Baseline

Cognitive Efficiency

Timeframe: Baseline

Functional Behaviors

Timeframe: Baseline

Emotional Functioning

Timeframe: 3 Weeks

Emotional Functioning

Timeframe: 6 Weeks

Emotional Functioning

Timeframe: 12 Weeks

Emotional Functioning

Timeframe: 18 Weeks

Cognitive Efficiency

Timeframe: 3 Weeks

Trial details

NCT IDNCT01339806

SponsorBrooke Army Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Traumatic Brain Injury With Brief Loss of Consciousness trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Emotional Functioning

Timeframe: Baseline

Cognitive Efficiency

Timeframe: Baseline

Functional Behaviors

Timeframe: Baseline

Emotional Functioning

Timeframe: 3 Weeks

Emotional Functioning

Timeframe: 6 Weeks

Emotional Functioning

Timeframe: 12 Weeks

Emotional Functioning

Timeframe: 18 Weeks

Cognitive Efficiency

Timeframe: 3 Weeks