Strategy + RehaCom for Memory Rehabilitation in Traumatic Brain Injury (TBI)

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the effectiveness of RehaCom, a computerized treatment for memory deficits, in a 16-session, interactive course. Following a manualized approach, the Rehacom modules will be used for the repeated application of the content acquired during 1-on-1 memory strategy training. The goal is to improve face/name, list and verbal memory of patients who survived a moderate to severe traumatic brain injury.

Detailed Description
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This randomized clinical trial (RCT) consists of 20 chronic moderate-to-severe TBI patients who will receive memory strategy training and complete three memory modules of the RehaCom at one of the Kessler Foundation locations. Changes in attention, processing speed, verbal/non-verbal new learning and memory (NLM) and executive control will be assessed via pre/post and 3-month follow-up assessments before and after the 8-10 week intervention. Self-report questionnaires will also track functional and emotional outcomes such as mood and anxiety, cognition, quality of life, self-efficacy, deficit awareness, community participation, and readiness for occupational functioning

Official Title
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RehaCom Memory Modules in Moderate-to-severe Traumatic Brain Injury (TBI)

Conditions
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Traumatic Brain Injury With Loss of Consciousness

Intervention / Treatment
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* Device: RehaCom (software)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read and speak English fluently at the 5th grade level (for testing; software has multilingual support) Had a TBI at least 1 year ago No history of learning disorders during school years Able to use a personal computer (PC) non-stop for 1 hour without health or visual complaints; able to press keyboard buttons.No history of learning disorders Exclusion Criteria: Actively participating in another intervention study Distance to Kessler Foundation East Hanover or West Orange location is more than 20 miles.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: This study is a double-blind randomized clinical trial. Participants will be randomly assigned to a treatment group or wait-list control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Receive intervention 2 weeks after group assignment. | Device: RehaCom (software)<br>* RehaCom software has gamified, interactive modules that will help participants practice the application of various memory strategies at custom, increasingly more difficult levels. Instructor will also use the software to teach and demonstrate the use of memory strategies with the domains targeted (i.e., list learning, remembering written/verbal information, and memory for names/faces).<br>|
| Other: Group B<br>Wait List - Receive intervention 3 months after initial testing. | Device: RehaCom (software)<br>* RehaCom software has gamified, interactive modules that will help participants practice the application of various memory strategies at custom, increasingly more difficult levels. Instructor will also use the software to teach and demonstrate the use of memory strategies with the domains targeted (i.e., list learning, remembering written/verbal information, and memory for names/faces).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in California Verbal Learning Test - II (CVLT-II) performance | We will use the raw scores for free and cued delayed recall [0-16] where higher scores indicate better verbal recall. | Baseline & 10-14 weeks after baseline assessment | 
| Change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Story Memory performance | Raw scores from Story A and Story B recall [0-50], where higher scores indicate better recall. | baseline & 10-14 weeks after baseline assessment | 
| Change in Wechsler Memory Scale III - Faces II performance | Delayed Recall Score [0-48] where higher scores indicate better recall. | baseline & 10-14 weeks after baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Face memory, Verbal Memory, Learning, Cognition, Memory training, Pilot study, compensatory memory strategies, cognitive rehabilitation