IRM Cognition in Patients With Head Trauma

• Conditions: Brain-damaged Patients
• Interventions: Other: Cognitive rehabilitation program

• Registration Number: NCT03181373
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.

Detailed Description

The following data are collected in 3 months, 12 months then 24 months after the accident with followed data collection :

* Clinical, neuropsychological assessments

* Diffusion magnetic resonance imaging (MRI) for the reconstruction of anatomical pathways

* Functional imaging data.

Study Timeline

• Study Start: 2014-09-26
• Status Verified: 2017-05
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-06-07
• Last Update Submitted: 2017-06-07
• Study First Posted: 2017-06-08
• Last Update Posted: 2017-06-08
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients, over the age of 18.
• Mild traumatic brain injury (Initial Glasgow score between 9 and 12)
• Severe brain injury (Initial Glasgow score between 3 and 8),
• Diffuse axonal injury and/or focal lesions.

Exclusion Criteria

• Patients with MRI contraindications,
• Antecedents of brain lesions,
• Important lesions of the lobes and cortex on cerebral CT,
• Anoxic lesions related to cardiorespiratory arrest,
• Must be able to perform neuropsychological tests,
• Visual and auditory impairments.
• Aphasia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traumatic brain injury population	Cognitive rehabilitation program	Defined population : traumatic brain injury population

Primary Outcome Measures

Name	Time	Method
Changes in Baseline standardized volume of the white matter fascicles	at 3, 12 and 24 months	determined on the "iplan" software. Baseline measured at 3 months after brain traumatic injury.

Secondary Outcome Measures

Name	Time	Method
Location of activation clusters	at 3, 12 and 24 months	during functional MRI for attention, motor, working memory, language tasks.
Measure of the volume of activations clusters	at 3, 12 and 24 months	during functional MRI for attention, motor, working memory, language tasks.

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France