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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Traumatic Brain Injury With Loss of Consciousness
• Intervention / Treatment: Device: RehaCom (software)

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: New Jersey Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): November 28, 2022
• Study Completion (Anticipated): November 28, 2022

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cognition; TBI; cognitive rehabilitation; Pilot study; Learning; Verbal Memory; Memory training; Face memory; compensatory memory strategies
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Consciousness Disorders; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Unconsciousness
• Other Study ID Numbers: E-1016-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be available at the individual level except for parties identified by the New Jersey Health Foundation (funding agency) and approved/mandated by the Kessler Foundation Institutional Review Board (IRB).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes