Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

Detailed Description
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The most common impairments following blast-induced traumatic brain injury (bTBI) are cognitive deficits in the domain of executive functioning, learning and memory, and functional and psychosocial disabilities that are closely related to these cognitive deficits. There are no treatment protocols available to address the multiple cognitive impairments in bTBI, but cognitive rehabilitation has proven efficacious in the treatment of non-blast TBI. The cognitive training modules the investigators plan to evaluate have improved organization and memory function in patients with non-blast TBI, but it is unknown whether their efficacy exceeds that of programs that focus only on education and support. This study is a between group comparison of a cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function, and an active control group receiving educational intervention geared at personal management of TBI-related symptoms.

Official Title
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Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury

Conditions
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Traumatic Brain Injury, Cognitive Symptoms

Intervention / Treatment
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* Behavioral: Cognitive Intervention
* Behavioral: Educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) active-duty personnel or Veterans exposed to blast Meets criteria for mild TBI loss of consciousness (LOC) of 30 min or less Age: 21- 50 Exclusion Criteria: Evidence of penetrating head injury History of previous neurological diagnosis History of previous psychotic disorder prior to the blast exposure Hearing or vision impairment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Cognitive intervention | Behavioral: Cognitive Intervention<br>* Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function<br>|
| Active Comparator: Arm 2<br>Educational intervention | Behavioral: Educational intervention<br>* Educational intervention is geared at personal management of TBI-related symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functioning | Scaled Score on the standardized neuropsychological testing | Ten weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily functioning | Total Score on the daily functioning measure | Ten weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation Outcome, Cognitive treatment, TBI