Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury (NCT03874416) | Clinical Trial Compass
UnknownNot Applicable
Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
France54 participantsStarted 2021-01-25
Plain-language summary
The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration.
As secondary objectives, the study aims to:
* demonstrate improvement of specific neuropsychological tests of working memory;
* demonstrate improvement of non-specific tasks involving working memory;
* assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect;
* demonstrate improvement of social integration ability and quality of life;
* demonstrate persistence of effects at 3 months and 6 months after the end of treatment;
* demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Index of working memory (IWM) of Wechsler Adult Intelligence Scale (WAIS-IV) \< 85 or p \< .05 between IWM and one of the WAIS-IV index;
. Less than 70% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task as mental calculation;
. Less than 89% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task of articulatory suppression;
. Less than 70% correct responses on Brown-Peterson tasks test in the visuospatial modality with an interfering motor task.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportions of simultaneous responders
Timeframe: 3 months after the first rehabilitation session