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Search / Trial NCT03874416

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 12, 2019

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Moderate To Severe Traumatic Brain Injury Cognitive Rehabilitation Working Memory Daily Life Function Working Memory Questionnaire, Wmq Brown Peterson Test

ClinConnect Summary

This clinical trial is studying a special type of therapy designed to help people who have had a moderate to severe traumatic brain injury (TBI) improve their working memory. Working memory is the ability to hold and use information for short periods, which is important for daily tasks. The trial compares this focused cognitive rehabilitation program, which lasts for three months, to a more general rehabilitation program. The goal is to see if the specific therapy can help participants do better in everyday activities, improve their scores on memory tests, and enhance their quality of life.

To be eligible for this study, participants must be between 18 and 65 years old and have experienced a moderate to severe TBI at least six months prior. They should also have noticeable problems with their working memory. Participants will receive support and training during the three-month program and will be followed up to see how well they maintain any improvements over the next six months. It's important to note that individuals with certain pre-existing conditions, recent psychological issues, or those who are pregnant or breastfeeding cannot participate. Overall, this trial aims to provide valuable insights into how targeted therapy can help individuals regain cognitive functions and improve their daily lives after a brain injury.

Gender

ALL

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.

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Garches, Hauts De Seine, France

Patients applied

0 patients applied

Trial Officials

Claire Vallat-Azouvi, PhD

Principal Investigator

Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF

Philippe Azouvi, MD, PhD

Study Director

Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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