Status:
UNKNOWN
Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Moderate to Severe Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 dis...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03874416
Start Date
January 25 2021
End Date
April 1 2025
Last Update
September 6 2023
Active Locations (1)
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1
Physical medicine and rehabilitation department, Raymond Poincaré Hospital
Garches, Hauts-de-seine, France, 92380