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

Primary Purpose

Traumatic Brain Injury With Loss of Consciousness

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RehaCom (software)
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury With Loss of Consciousness focused on measuring TBI, Face memory, Verbal Memory, Learning, Cognition, Memory training, Pilot study, compensatory memory strategies, cognitive rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

Receive intervention 2 weeks after group assignment.

Wait List - Receive intervention 3 months after initial testing.

Outcomes

Primary Outcome Measures

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.
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.
Change in Wechsler Memory Scale III - Faces II performance
Delayed Recall Score [0-48] where higher scores indicate better recall.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2019
Last Updated
March 30, 2022
Sponsor
Kessler Foundation
Collaborators
New Jersey Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04239456
Brief Title
Strategy + RehaCom for Memory Rehabilitation in Traumatic Brain Injury (TBI)
Acronym
REHACOM-NJHF
Official Title
RehaCom Memory Modules in Moderate-to-severe Traumatic Brain Injury (TBI)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
November 28, 2022 (Anticipated)
Study Completion Date
November 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
New Jersey Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury With Loss of Consciousness
Keywords
TBI, Face memory, Verbal Memory, Learning, Cognition, Memory training, Pilot study, compensatory memory strategies, cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Receive intervention 2 weeks after group assignment.
Arm Title
Group B
Arm Type
Other
Arm Description
Wait List - Receive intervention 3 months after initial testing.
Intervention Type
Device
Intervention Name(s)
RehaCom (software)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in California Verbal Learning Test - II (CVLT-II) performance
Description
We will use the raw scores for free and cued delayed recall [0-16] where higher scores indicate better verbal recall.
Time Frame
Baseline & 10-14 weeks after baseline assessment
Title
Change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Story Memory performance
Description
Raw scores from Story A and Story B recall [0-50], where higher scores indicate better recall.
Time Frame
baseline & 10-14 weeks after baseline assessment
Title
Change in Wechsler Memory Scale III - Faces II performance
Description
Delayed Recall Score [0-48] where higher scores indicate better recall.
Time Frame
baseline & 10-14 weeks after baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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).

Learn more about this trial

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

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