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

Traumatic Brain Injury With Loss of Consciousness Clinical Trial

— REHACOM-NJHF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04239456
• Other study ID #: E-1016-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: November 28, 2022

Study information

• Verified date: March 2022
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 28, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury With Loss of Consciousness
• Unconsciousness
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	New Jersey Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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