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

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ClinicalTrials.gov Identifier: NCT04239456
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
New Jersey Medical School
Information provided by (Responsible Party):
Kessler Foundation

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) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : December 1, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


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).

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).




Primary Outcome Measures :
  1. Change in California Verbal Learning Test - II (CVLT-II) performance [ Time Frame: 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.

  2. Change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Story Memory performance [ Time Frame: baseline & 10-14 weeks after baseline assessment ]
    Raw scores from Story A and Story B recall [0-50], where higher scores indicate better recall.

  3. Change in Wechsler Memory Scale III - Faces II performance [ Time Frame: baseline & 10-14 weeks after baseline assessment ]
    Delayed Recall Score [0-48] where higher scores indicate better recall.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239456


Contacts
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Contact: Nuri Erkut Kucukboyaci, PhD 6172307004 ekucukboyaci@kesslerfoundation.org
Contact: Nancy Chiaravalloti, PhD 9733248440 nchiaravalloti@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Nuri Erkut Kucukboyaci, PhD    617-230-7004    ekucukboyaci@kesslerfoundation.org   
Contact: Nancy Chiaravalloti, PhD    9733248440    nchiaravalloti@kesslerfoundation.org   
Principal Investigator: Nuri Erkut Kucukboyaci, PhD         
Principal Investigator: Nancy Chiaravalloti, PhD         
Sponsors and Collaborators
Kessler Foundation
New Jersey Medical School
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT04239456    
Other Study ID Numbers: E-1016-18
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).

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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
Keywords provided by Kessler Foundation:
TBI
Face memory
Verbal Memory
Learning
Cognition
Memory training
Pilot study
compensatory memory strategies
cognitive rehabilitation
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Unconsciousness
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations