Cognitive rehabilitation for improving memory after traumatic brain injury
A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
This study is testing a special memory training program to see if it can help people with moderate to severe brain injuries improve their daily functioning and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Garches, Hauts-de-seine) |
| Trial ID | NCT03874416 on ClinicalTrials.gov |
What this trial studies
This study aims to improve daily functioning and cognitive performance in patients with moderate to severe traumatic brain injury (TBI) who experience working memory deficits. Participants will be randomized to receive either a specific cognitive rehabilitation program focused on working memory or a non-specific rehabilitation program over three months. The study will assess improvements in neuropsychological tests, social integration, and quality of life, as well as the persistence of these effects over time. A total of 54 patients will be enrolled across six centers in the Île-de-France region.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have experienced moderate to severe TBI and have documented working memory deficits.
Not a fit: Patients who do not have working memory complaints or who are outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this rehabilitation program could significantly enhance the daily functioning and quality of life for patients recovering from traumatic brain injury.
How similar studies have performed: Previous studies have shown efficacy in cognitive rehabilitation programs for TBI, suggesting potential success for this specific approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 18 - 65 years; * Moderate to severe TBI (Glasgow score between 3 and 12 in the 24 first hours); * At least 6 months following TBI; * Complaint related to working memory in daily life (scale \> 29 of questionnaire of complaint on working memory (WMQ), and established deficit of working memory by one of the following criteria: 1. 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; 2. Less than 70% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task as mental calculation; 3. Less than 89% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task of articulatory suppression; 4. Less than 70% correct responses on Brown-Peterson tasks test in the visuospatial modality with an interfering motor task. * Prior medical examination; * Correct vision after visual acuity correction; * Stable neurological or psychoactive treatment for at least 4 weeks, if applicable; * Able to move to the center where rehabilitation will be performed; * Covered by a health insurance; * Signed consent of patient or of the guardian. Exclusion Criteria: * History of central nervous system disorder, or history of psychological disorder or substance abuse; * Prior specific cognitive rehabilitation of working memory; * Instrumental activities disabilities, cognitive disorder, behavioural disorders or major psychiatric disorder; * Major anxio-depressive syndrome or present psychiatric disorder which can interfere with experimental procedure or measured variables; * Pregnant or breastfeeding woman.
Where this trial is running
Garches, Hauts-de-seine
- Physical medicine and rehabilitation department, Raymond Poincaré Hospital — Garches, Hauts-de-seine, France (Recruiting)
Study contacts
- Principal investigator: Claire Vallat-Azouvi, PhD — Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF
- Study coordinator: Claire Vallat-Azouvi, PhD
- Email: claire.vallat-azouvi@univ-paris8.fr
- Phone: +33 1 47 10 76 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.