Informations générales (source: ClinicalTrials.gov)
A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
janvier 2021
avril 2025
03 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE JACQUES ARNAUD | VALLAT-AZOUVI Claire | 13/12/2025 07:42:35 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:42:35 | Contacter | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Raymond Poincaré | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Physical medicine and rehabilitation department, Raymond Poincaré Hospital - 92380 - Garches - Hauts-de-seine - France | Claire Vallat-Azouvi, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.