Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury (REHAB-MDT)

A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Traumatic Brain Injury
• Intervention / Treatment: Other: Specific rehabilitation; Other: Non-specific 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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Vallat-Azouvi, PhD; Phone Number: +33 1 47 10 76 47; Email: claire.vallat-azouvi@univ-paris8.fr
• Study Contact Backup: Name: Philippe Azouvi, MD, PhD; Phone Number: +33 1 47 10 70 78; Email: philippe.azouvi@aphp.fr

Study Locations

• France
  • Hauts-de-seine
    • Garches, Hauts-de-seine, France, 92380
      • Recruiting
      • Physical medicine and rehabilitation department, Raymond Poincaré Hospital
      • Contact: Claire Vallat-Azouvi, PhD; Phone Number: + 33 1 47 10 76 47; Email: claire.vallat-azouvi@univ-paris8.fr
      • Contact: Philippe Azouvi, MD, PhD; Phone Number: + 33 1 47 10 70 78; Email: philippe.azouvi@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific rehabilitation of working memory; Specific rehabilitation of working memory according to hierarchized rehabilitation.	Other: Specific rehabilitation; Experimental rehabilitation of working memory: 3 sessions per week during 3 months, for a total 36 sessions.
Active Comparator: Control group; Non-specific rehabilitation of working memory, usual therapy.	Other: Non-specific rehabilitation; Usual non-specific rehabilitation treatment for moderate to severe TBI in healthcare facilities: 2-3 sessions per week for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: increase of at least 12 points on WMQ scale,; at least 13% score improvement on the verbal or visuo-spatial Brown-Peterson Task.	3 months after the first rehabilitation session

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Claire Vallat-Azouvi, PhD, Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF; Study Director: Philippe Azouvi, MD, PhD, Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cognitive rehabilitation; working memory; moderate to severe traumatic brain injury; daily life function; Working Memory Questionnaire, WMQ; Brown-Peterson test
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: K160902J; PHRIP-16-0380 (Other Identifier: Ministry of health); 2018-A02713-52 (Registry Identifier: IDRCB (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No