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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03181373
Enrollment
20
Registered
2017-06-08
Start date
2014-09-26
Completion date
2018-12-31
Last updated
2017-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain-damaged Patients

Keywords

Craniocerebral injury, Mild and severe brain traumatic injury, Neuropsychological abilities, Clinical assessment, Anatomical and functional imaging

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.

Interventions

Sponsors

Clementel
CollaboratorUNKNOWN
Maurice Gantchoula
CollaboratorUNKNOWN
LADAPT
CollaboratorOTHER
APF
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Baseline standardized volume of the white matter fasciclesat 3, 12 and 24 monthsdetermined on the iplan software. Baseline measured at 3 months after brain traumatic injury.

Secondary

MeasureTime frameDescription
Measure of the volume of activations clustersat 3, 12 and 24 monthsduring functional MRI for attention, motor, working memory, language tasks.
Location of activation clustersat 3, 12 and 24 monthsduring functional MRI for attention, motor, working memory, language tasks.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026