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| ID | Type | Description | Link |
|---|---|---|---|
| PHRIP-16-0380 | Other Identifier | Ministry of health | |
| 2018-A02713-52 | Registry Identifier | IDRCB (ANSM) |
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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:
Working memory is an essential cognitive function which allows to store briefly and treat simultaneous informations, but is often altered after a moderate to severe TBI. This alteration results in disabilities and social integration difficulties in the post TBI patients. The study team had developped a standardized and hierarchized rehabilitation program of working memory. Several experiments have shown the efficacy of the program which is now used in routine care by speech-language pathologists and neuropsychologists. However it is necessary to provide a robust demonstration of its efficacy in improving function in daily life.
This randomized multicenter study will be performed in 6 centers in the area of ÃŽle-de-France. 54 patients will be randomized 1:1 to receive either specific rehabilitation of working memory or non-specific rehabilitation. A 10-month follow-up is planned for patients of the two arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific rehabilitation of working memory | Experimental | Specific rehabilitation of working memory according to hierarchized rehabilitation. |
|
| Control group | Active Comparator | Non-specific rehabilitation of working memory, usual therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific rehabilitation | Other | Experimental rehabilitation of working memory: 3 sessions per week during 3 months, for a total 36 sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of simultaneous responders | A patient will be considered as a responder if he improves simultaneously on the Working Memory Questionnaire (WMQ) and the Brown-Peterson Task. Proportions will be calculated of patients simultaneously improving on the Working Memory Questionnaire (WMQ) and the Brown-Peterson Task:
| 3 months after the first rehabilitation session |
| Measure | Description | Time Frame |
|---|---|---|
| Working Memory Questionnaire during rehabilitation program | The Working Memory Questionnaire (WMQ), an auto-questionnaire elaborated by the study team, will be used. The WMQ is a self-administered scale, addressing three dimensions of working memory: short-term storage, attention, and executive control. It is a self-assessment questionnaire comprising 30 questions scored on a five-point Likert scale, ranging from 0 ("no problem at all") to 4 ("very severe problem in everyday life"). The total score will be used. |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Vallat-Azouvi, PhD | Contact | +33 1 47 10 76 47 | claire.vallat-azouvi@univ-paris8.fr | |
| Philippe Azouvi, MD, PhD | Contact | +33 1 47 10 70 78 | philippe.azouvi@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claire Vallat-Azouvi, PhD | Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF | Principal Investigator |
| Philippe Azouvi, MD, PhD | Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical medicine and rehabilitation department, Raymond Poincaré Hospital | Recruiting | Garches | Hauts-de-seine | 92380 | France |
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Single blind trial with 2 parallel arms:
Specific rehabilitation of working memory vs. non-specific rehabilitation
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Clinical assessment will be performed by an assessor blinded to group allocation.
| Non-specific rehabilitation | Other | Usual non-specific rehabilitation treatment for moderate to severe TBI in healthcare facilities: 2-3 sessions per week for 3 months. |
|
| At baseline, 3 months, 6 months and 9 months |
| Cognitive task of working memory | Working memory span tasks | At baseline, 3 months, 6 months and 9 months |
| Cognitive task of working memory | Verbal and visuospatial working memory. | At baseline, 3 months, 6 months and 9 months |
| Cognitive task of working memory | n-back task | At baseline, 3 months, 6 months and 9 months |
| Cognitive task of working memory | Brown-Peterson Visual. | At baseline, 3 months, 6 months and 9 months |
| Cognitive task of working memory | reading span task. | At baseline, 3 months, 6 months and 9 months |
| Cognitive task of working memory | Working Memory Index (WISC-IV). | At baseline, 3 months, 6 months and 9 months |
| Cognitive task of working memory | divided attention task | At baseline, 3 months, 6 months and 9 months |
| Arithmetic resolution | Non-specific tasks involving working memory: arithmetic resolution ability by WAIS index | At baseline, 3 months and 6 months |
| Non-targeted cognitive measurements | Executive functions will be assessed. | At baseline, 3 months and 6 months |
| Non-targeted cognitive measurements | Long-term memory will be assessed. | At baseline, 3 months and 6 months |
| Non-targeted cognitive measurements | The speed of treatment will be assessed. | At baseline, 3 months and 6 months |
| Social functioning assessement | Assessed by Manual for Sydney Psychosocial Reintegration Scale (SPRS) | At baseline, 3 months, 6 months and 9 months |
| Quality of life assessment | Assessed by Qolibri scale | At baseline, 3 months, 6 months and 9 months |
| Quality of life assessment | Assessed by EQ5D-5 | At baseline, 3 months, 6 months and 9 months |
| Acceptability | Compliance of rehabilitation program: duration of training of speech-language pathologist and psychologist to the rehabilitation program. | At baseline, 3 months and 6 months |
| Acceptability | Compliance of rehabilitation program: duration of session. | At baseline, 3 months and 6 months |
| Acceptability | Compliance of rehabilitation program: patient's satisfaction of care (Client Satisfaction Questionnaire (CSQ-8)). | At baseline, 3 months and 6 months |
| Acceptability | Compliance of rehabilitation program: presence during rehabilitation session of working memory. | At baseline, 3 months and 6 months |