REHACOM-NJHF: Strategy + RehaCom for Memory Rehabilitation in Traumatic Brain Injury (TBI)

Sponsor

Kessler Foundation (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04239456

Collaborator

New Jersey Medical School (Other)

Enrollment

Location

Arms

47.9

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury With Loss of Consciousness	Device: RehaCom (software)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Outcomes Assessor)

Masking Description:

Group assignments will be concealed and assessments and interventions will be conducted by trained staff blinded to each other's findings and data.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Nov 28, 2022

Anticipated Study Completion Date :

Nov 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Receive intervention 2 weeks after group assignment.	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).
Other: Group B Wait List - Receive intervention 3 months after initial testing.	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).

Arm

Intervention/Treatment

Experimental: Group A

Receive intervention 2 weeks after group assignment.

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).

Other: Group B

Wait List - Receive intervention 3 months after initial testing.

Device: RehaCom (software)

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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