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

NCT04239456 | Unknown FDA Device

• 1 other identifier: E-1016-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury With Loss of Consciousness

Keywords

TBI; Face memory; Verbal Memory; Learning; Cognition; Memory training; Pilot study; compensatory memory strategies; cognitive rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Receive intervention 2 weeks after group assignment.

Device: RehaCom (software)

Group B

OTHER

Wait List - Receive intervention 3 months after initial testing.

Device: RehaCom (software)

Interventions

RehaCom (software) DEVICE

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).

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Actively participating in another intervention study
• Distance to Kessler Foundation East Hanover or West Orange location is more than 20 miles.

Sponsors & Collaborators

• Kessler Foundation: lead
• New Jersey Medical School: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Group assignments will be concealed and assessments and interventions will be conducted by trained staff blinded to each other's findings and data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a double-blind randomized clinical trial. Participants will be randomly assigned to a treatment group or wait-list control group.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 27, 2020
• Study Start: December 1, 2018
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)