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

NCT03874416 | Unknown

• 3 other identifiers: K160902JPHRIP-16-03802018-A02713-52
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Working Memory Questionnaire during rehabilitation program

  At baseline, 3 months, 6 months and 9 months

• Cognitive task of working memory

  At baseline, 3 months, 6 months and 9 months

• Cognitive task of working memory

  At baseline, 3 months, 6 months and 9 months

• Cognitive task of working memory

  At baseline, 3 months, 6 months and 9 months

• Cognitive task of working memory

  At baseline, 3 months, 6 months and 9 months

Study Arms (2)

Specific rehabilitation of working memory

EXPERIMENTAL

Specific rehabilitation of working memory according to hierarchized rehabilitation.

Other: Specific rehabilitation

Control group

ACTIVE COMPARATOR

Non-specific rehabilitation of working memory, usual therapy.

Other: Non-specific rehabilitation

Interventions

Specific rehabilitation OTHER

Experimental rehabilitation of working memory: 3 sessions per week during 3 months, for a total 36 sessions.

Specific rehabilitation of working memory

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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• Less than 70% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task as mental calculation;
• Less than 89% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task of articulatory suppression;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Physical medicine and rehabilitation department, Raymond Poincaré Hospital

Garches, Hauts-de-seine, 92380, France

RECRUITING

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical assessment will be performed by an assessor blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind trial with 2 parallel arms: Specific rehabilitation of working memory vs. non-specific rehabilitation

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: March 14, 2019
• Study Start: January 25, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)