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.
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 Île-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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
Experimental rehabilitation of working memory: 3 sessions per week during 3 months, for a total 36 sessions.
Usual non-specific rehabilitation treatment for moderate to severe TBI in healthcare facilities: 2-3 sessions per week for 3 months.
Physical medicine and rehabilitation department, Raymond Poincaré Hospital
Garches, Hauts-de-seine, France
RECRUITINGProportions 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: * increase of at least 12 points on WMQ scale, * at least 13% score improvement on the verbal or visuo-spatial Brown-Peterson Task.
Time frame: 3 months after the first rehabilitation session
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.
Time frame: At baseline, 3 months, 6 months and 9 months
Cognitive task of working memory
Working memory span tasks
Time frame: At baseline, 3 months, 6 months and 9 months
Cognitive task of working memory
Verbal and visuospatial working memory.
Time frame: At baseline, 3 months, 6 months and 9 months
Cognitive task of working memory
n-back task
Time frame: At baseline, 3 months, 6 months and 9 months
Cognitive task of working memory
Brown-Peterson Visual.
Time frame: At baseline, 3 months, 6 months and 9 months
Cognitive task of working memory
reading span task.
Time frame: At baseline, 3 months, 6 months and 9 months
Cognitive task of working memory
Working Memory Index (WISC-IV).
Time frame: At baseline, 3 months, 6 months and 9 months
Cognitive task of working memory
divided attention task
Time frame: At baseline, 3 months, 6 months and 9 months
Arithmetic resolution
Non-specific tasks involving working memory: arithmetic resolution ability by WAIS index
Time frame: At baseline, 3 months and 6 months
Non-targeted cognitive measurements
Executive functions will be assessed.
Time frame: At baseline, 3 months and 6 months
Non-targeted cognitive measurements
Long-term memory will be assessed.
Time frame: At baseline, 3 months and 6 months
Non-targeted cognitive measurements
The speed of treatment will be assessed.
Time frame: At baseline, 3 months and 6 months
Social functioning assessement
Assessed by Manual for Sydney Psychosocial Reintegration Scale (SPRS)
Time frame: At baseline, 3 months, 6 months and 9 months
Quality of life assessment
Assessed by Qolibri scale
Time frame: At baseline, 3 months, 6 months and 9 months
Quality of life assessment
Assessed by EQ5D-5
Time frame: 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.
Time frame: At baseline, 3 months and 6 months
Acceptability
Compliance of rehabilitation program: duration of session.
Time frame: At baseline, 3 months and 6 months
Acceptability
Compliance of rehabilitation program: patient's satisfaction of care (Client Satisfaction Questionnaire (CSQ-8)).
Time frame: At baseline, 3 months and 6 months
Acceptability
Compliance of rehabilitation program: presence during rehabilitation session of working memory.
Time frame: At baseline, 3 months and 6 months
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