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

Not Applicable

• Conditions: Traumatic Brain Injury With Loss of Consciousness

• Registration Number: NCT04239456
• Lead Sponsor: Kessler Foundation

Brief Summary

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

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

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-11-28
• Study Completion: 2022-11-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States