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Clinical Trials in France / NCT04534777
Recruiting Observational

Multimodal Neuroprognostication in Disorders of Consciousness

NCT04534777 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2020-09-09
Last updated
2024-02-05

Condition(s) studied

Consciousness Disorder

Investigational drug(s) / intervention(s)

repeated neurological, behavioral assessments and conventional, quantitative and functional brain imagery

repeated neurological, behavioral assessments and conventional, quantitative and functional brain imagery: Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.

Study summary

Disorders of consciousness frequently occur at the acute phase of brain injuries. For the most severe cases, consciousness impairment can be prolonged. To optimize the medical plan and the goal of care, it is fundamental to have precise tools to predict chances of recovery of consciousness and potential disability. Currently, multimodal assessment including behavioral, neurophysiological and neuroimaging technics is recommended. However, the respective predictive values of these markers are poorly understood and decision making is challenging when results are contradictory

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery) 2. Brain injuries on CT or MRI (e.g. TBI) (traumatic brain-injured ), anoxia or stroke related lesions, etc…) 3. Age between 18 and 80 years Exclusion Criteria: 1. Deep sedation (e.g. elevated ICP(intracranial pressure ), refractory status epilepticus) 2. Sever known neurodegenerative disease (e.g. Alzheimer disease) 3. Pregnancy

Primary outcome measure(s)

  • prognosis accuracy of respective predictive markers of consciousness recovery — 24 MONTHS
    Calculation of the value (Chi2 tests, specificity, sensitivity, positive and negative predictive values of each tests and of their combinations to distinguish patients states and outcome (24-month GOS-E ≥ 4 or \< 4).

Trial sites (1)

FacilityCityRegionStatus
Hôpital Pitié Salpétrière Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04534777 on ClinicalTrials.gov ↗ ← All trials in France