Clinical trial NCT03874416: Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Official title: A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Moderate to Severe Traumatic Brain Injury
Keywords: moderate to severe traumatic brain injury
cognitive rehabilitation
working memory
daily life function
Working Memory Questionnaire, WMQ
Brown-Peterson test
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind trial with 2 parallel arms:

Specific rehabilitation of working memory vs. non-specific rehabilitation
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Proportions of simultaneous responders
timeFrame: 3 months after the first rehabilitation session
Secondary outcomes:
measure: Working Memory Questionnaire during rehabilitation program
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Cognitive task of working memory
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Cognitive task of working memory
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Cognitive task of working memory
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Cognitive task of working memory
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Cognitive task of working memory
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Cognitive task of working memory
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Cognitive task of working memory
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Arithmetic resolution
timeFrame: At baseline, 3 months and 6 months
measure: Non-targeted cognitive measurements
timeFrame: At baseline, 3 months and 6 months
measure: Non-targeted cognitive measurements
timeFrame: At baseline, 3 months and 6 months
measure: Non-targeted cognitive measurements
timeFrame: At baseline, 3 months and 6 months
measure: Social functioning assessement
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Quality of life assessment
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Quality of life assessment
timeFrame: At baseline, 3 months, 6 months and 9 months
measure: Acceptability
timeFrame: At baseline, 3 months and 6 months
measure: Acceptability
timeFrame: At baseline, 3 months and 6 months
measure: Acceptability
timeFrame: At baseline, 3 months and 6 months
measure: Acceptability
timeFrame: At baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Physical medicine and rehabilitation department, Raymond Poincaré Hospital
state: Hauts-de-seine
Study officials:
affiliation: Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF
name: Claire Vallat-Azouvi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches
name: Philippe Azouvi, MD, PhD
role: STUDY_DIRECTOR
References: