NCT04239456

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Traumatic Brain Injury With Loss of Consciousness

Interventions

Type	Name	Description
DEVICE	RehaCom (software)	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).

Timeline

• Start date: 2018-12-01
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2020-01-27
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study