Traumatic Brain Injury With Loss of ConsciousnessREHACOM-NJHFNCT04239456
Strategy + RehaCom for Memory Rehabilitation in Traumatic Brain Injury (TBI)
A study testing RehaCom (software) in people with Traumatic Brain Injury With Loss of Consciousness, run by Kessler Foundation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury With Loss of Consciousness
- What is being tested?
- RehaCom (software)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 28 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Actively participating in another intervention study
- Distance to Kessler Foundation East Hanover or West Orange location is more than 20 miles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RehaCom Memory Modules in Moderate-to-severe Traumatic Brain Injury (TBI)
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.
Read the 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
- Being tested
- RehaCom (software)
- Keywords
- TBI, Face memory, Verbal Memory, Learning, Cognition, Memory training, Pilot study, compensatory memory strategies, cognitive rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Receive intervention 2 weeks after group assignment. Receives: Device: RehaCom (software) |
| Group B | Other | Wait List - Receive intervention 3 months after initial testing. Receives: Device: RehaCom (software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline & 10-14 weeks after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Dec 2018
- Primary completion28 Nov 2022 (estimated)
- Study completion28 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury With Loss of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239456
- Sponsor's protocol ID
- E-1016-18
- Acronym
- REHACOM-NJHF
- Status last verified
- Mar 2022
- First submitted
- 17 Dec 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RehaCom Memory Modules in Moderate-to-severe Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT04239456
- Acronym / sponsor ID
- REHACOM-NJHF / E-1016-18
- Keywords
- TBI, Face memory, Verbal Memory, Learning, Cognition, Memory training, Pilot study, compensatory memory strategies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- New Jersey Medical School
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 28 Nov 2022 (estimated)
- Study completion
- 28 Nov 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: RehaCom (software)Receive intervention 2 weeks after group assignment. |
| Group B | Other | Device: RehaCom (software)Wait List - Receive intervention 3 months after initial testing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Actively participating in another intervention study
- Distance to Kessler Foundation East Hanover or West Orange location is more than 20 miles.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Group A, Group B |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RehaCom (software) in people with Traumatic Brain Injury With Loss of Consciousness, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in California Verbal Learning Test - II (CVLT-II) performance (time frame: Baseline & 10-14 weeks after baseline assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.