Brain Training to Enhance Frontal Lobe Reasoning

Study Overview
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Brief Summary
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This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).

Detailed Description
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link to clinical trials methods paper http://trialsjournal.biomedcentral.com/track/pdf/10.1186/1745-6215-14-29?site=trialsjournal.biomedcentral.com

Official Title
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Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Brain Training Program 1
* Behavioral: Brain Training Program 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-65 years of age Sustained a traumatic brain injury at least 6 months previously Comprehend simple instructions, perform tasks and take part in intervention Read, speak and comprehend English Participate in tasks involving motor abilities such as use of at least one arm or hand Exclusion Criteria: Not proficient in reading, comprehending or speaking English Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy Women who are pregnant

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brain Training Program 1<br>Training Program focusing on providing educational information of cognitive issues related to TBI | Behavioral: Brain Training Program 1<br>* The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities.<br>|
| Experimental: Brain Training Program 2<br>Program focuses on strategies to address cognitive issues following TBI | Behavioral: Brain Training Program 2<br>* The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological changes | To examine short-term effects of treatment on cognition and real-life outcomes including psychological health, resilience, depressive symptoms, and symptoms of stress, in soldiers and civilians with TBI. Participants will undergo neuropsychological testing post-training (10 weeks), as well as 3-months post-training. | Neuropsychological changes from baseline to 10 weeks and 3 months post-training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain connectivity and activation changes | To examine any connectivity or activation changes in the brain as a result of treatment on fMRI measures. fMRI data will be taken post-training (10 weeks) as well as 3-months post-testing. | Neuropsychological changes from baseline to 10 weeks and 3 months post-training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Traumatic Brain Injury, combat related injury, blast injury, concussion, sleep problems, attention problems, memory problems, headaches, dizziness, OEF, Veterans, Civilian, OIF