IRM Cognition in Patients With Head Trauma

NCT ID: NCT03181373

Last Updated: 2017-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-26

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Brain-damaged Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Traumatic brain injury population

Defined population : traumatic brain injury population

Cognitive rehabilitation program

Intervention Type OTHER

Rehabilitation

Interventions

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Cognitive rehabilitation program

Rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clementel

UNKNOWN

Sponsor Role collaborator

Maurice Gantchoula

UNKNOWN

Sponsor Role collaborator

LADAPT

OTHER

Sponsor Role collaborator

APF

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

Other Identifiers

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CHU-328

Identifier Type: -

Identifier Source: org_study_id

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