IRM Cognition in Patients With Head Trauma

Brain-damaged Patients Clinical Trial

Official title:

Longitudinal Descriptive Study of the Correlation Between Cognitive Functions, White Matter Anatomical Pathways and Functional Magnetic Resonance Imaging Activations in Patients With Moderate to Severe Head Trauma.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03181373
• Other study ID #: CHU-328
• Status: Active, not recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: June 7, 2017
• Start date: September 26, 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain-damaged Patients
• Craniocerebral Trauma

Intervention

Other:
• Cognitive rehabilitation program
Rehabilitation

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	APF, Clementel, LADAPT, Maurice Gantchoula

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Baseline standardized volume of the white matter fascicles	determined on the "iplan" software. Baseline measured at 3 months after brain traumatic injury.	at 3, 12 and 24 months
Secondary	Measure of the volume of activations clusters	during functional MRI for attention, motor, working memory, language tasks.	at 3, 12 and 24 months
Secondary	Location of activation clusters	during functional MRI for attention, motor, working memory, language tasks.	at 3, 12 and 24 months