Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

Not Applicable

Recruiting

• Conditions: Moderate to Severe Traumatic Brain Injury
• Interventions: Other: Non-specific rehabilitation; Other: Specific rehabilitation

• Registration Number: NCT03874416
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2021-01-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Non-specific rehabilitation	Non-specific rehabilitation of working memory, usual therapy.
Specific rehabilitation of working memory	Specific rehabilitation	Specific rehabilitation of working memory according to hierarchized rehabilitation.

Primary Outcome Measures

Name	Time	Method
Proportions of simultaneous responders	3 months after the first rehabilitation session	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability	At baseline, 3 months and 6 months	Compliance of rehabilitation program: presence during rehabilitation session of working memory.
Arithmetic resolution	At baseline, 3 months and 6 months	Non-specific tasks involving working memory: arithmetic resolution ability by WAIS index
Cognitive task of working memory	At baseline, 3 months, 6 months and 9 months	divided attention task
Non-targeted cognitive measurements	At baseline, 3 months and 6 months	The speed of treatment will be assessed.
Social functioning assessement	At baseline, 3 months, 6 months and 9 months	Assessed by Manual for Sydney Psychosocial Reintegration Scale (SPRS)
Working Memory Questionnaire during rehabilitation program	At baseline, 3 months, 6 months and 9 months	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.
Quality of life assessment	At baseline, 3 months, 6 months and 9 months	Assessed by EQ5D-5

Trial Locations

Locations (1)

Physical medicine and rehabilitation department, Raymond Poincaré Hospital; 🇫🇷 Garches, Hauts-de-seine, France