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New treatment option for Coma
Official title Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest
ClinicalTrials.gov ID: NCT06617377
What this study is testing
- What it's testing
- To assess the performance of a predictive model resulting from the analysis of sMRI/fMRI/contrast-enhanced MRI-derived personalized connectomic data, as compared with standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict anoxoischemic coma neurological outcome at 6 months.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (male or female ≥ 18 years).
- Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset.
- Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in...
- Written informed consent from patient's legal representative.
- Affiliation or beneficiary to the French social security system.
You likely can't join if
- Brain death.
- Coma explained by other cause than CA.
- Likely poor neurological outcome based on early predictors, following ERC-ESCIM 2021 recommendations. In a comatose patient with GCS motor score ≤ 3...
- Decision of WLST previous to patient recruitment, based on early predictors of poor neurological outcome, age, co-morbidity, general organ function...
- Life expectancy shorter than 6 months based on pre-morbid conditions.
- Former neurological functional disability (mRS \> 2 before CA).
See the full eligibility criteria
- Adult patients (male or female ≥ 18 years).
- Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset.
- Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in normothermia conditions.
- Written informed consent from patient's legal representative.
- Affiliation or beneficiary to the French social security system.
- Brain death.
- Coma explained by other cause than CA.
- Likely poor neurological outcome based on early predictors, following ERC-ESCIM 2021 recommendations. In a comatose patient with GCS motor score ≤ 3 at ≥ 72 h from ROSC, in the absence of confounders, the identification...
- Decision of WLST previous to patient recruitment, based on early predictors of poor neurological outcome, age, co-morbidity, general organ function and patient's preferences.
- Life expectancy shorter than 6 months based on pre-morbid conditions.
- Former neurological functional disability (mRS \> 2 before CA).
- MRI contraindication: medical material not MRI compatible, claustrophobia
- Known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium
- Severe kidney failure defined as a KDIGO score \> 3 (glomerular filtration rate \< 30 ml/min/1.73 m2 or renal replacement therapy).
- Hemodynamic shock or severe respiratory failure precluding patient's transport and MRI scanning.
- Pregnancy or nursing woman.
- Patient under juridical protection.
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.