IRM Cognition in Patients With Head Trauma

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.

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

Study Overview

• Status: Unknown
• Conditions: Brain-damaged Patients
• Intervention / Treatment: Other: Cognitive rehabilitation program

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with traumatic brain injury

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traumatic brain injury population; Defined population : traumatic brain injury population	Other: Cognitive rehabilitation program; Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Clementel; Maurice Gantchoula; LADAPT; APF

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2014
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Clinical assessment; Craniocerebral injury; Mild and severe brain traumatic injury; Neuropsychological abilities; Anatomical and functional imaging
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: CHU-328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No