CompletedNot Applicable

Brain Network Disruptions Related to Traumatic Coma

France59 participantsStarted 2018-03-07

Plain-language summary

To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria for patients: * Male or female / age between 18 to 75 years. * Coma of traumatic or anoxic aetiology (GCS \< 10). * Early (\< 1 month after TBI) and after the complete withdrawal of sedative agents. * Written agreement for participation (legal responsible). Inclusion criteria for controls: * Male or female / age between 18 to 75 years, paired with patients (gender and age). * Written agreement for participation Exclusion criteria: * Patients without public insurance regime. * Pregnancy. * Specific contraindication to the use of MRI (metallic material) or PET (specific allergy related to the ligand). Exclusion criteria for controls: \- pharmacological treatments which could interfere with consciousness (left to the judgement of the investigator)

What they're measuring

Matrix of the neuroimaging data in PET examination

Timeframe: First Visit, within three days after day 0

Trial details

NCT IDNCT03482115

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-07

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