Clinical trial NCT04239456: Strategy + RehaCom for Memory Rehabilitation in Traumatic Brain Injury (TBI)
Official title: RehaCom Memory Modules in Moderate-to-severe Traumatic Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: New Jersey Medical School
First posted: 2020-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in California Verbal Learning Test - II (CVLT-II) performance
timeFrame: Baseline & 10-14 weeks after baseline assessment
measure: Change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Story Memory performance
timeFrame: baseline & 10-14 weeks after baseline assessment
measure: Change in Wechsler Memory Scale III - Faces II performance
timeFrame: baseline & 10-14 weeks after baseline assessment
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: