Multimodal Resonance Imaging for Outcome Prediction on Coma Patients

NCT00577954 | Completed

• 1 other identifier: P051061
• Study Type: observational
• Target: 417
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke, traumatic head injury, subarachnoid hemorrhage and cerebral anoxia are main causes of a coma condition implying severe brain damage and thus, poor prognosis. Clinicians are often in need for a tool able to predict the awakening of these patients. Multimodal MRI, associating the traditional morphological sequences with spectroscopy-MRI (MRS) and the diffusion tensor imaging, could provide such a prediction.

Conditions

Coma

Keywords

Coma; TBI; Stroke; SAH; Cerebral Anoxia; Multimodal MRI

Outcome Measures

Primary Outcomes (1)

• To define a quantified indicator resulting from the analysis of the multimodal MRI combined with clinical data to create a score to predict the 1 year outcome as measured by the dichotomized Glasgow Outcome Scale (extended version [GOSE]).

  one year

Secondary Outcomes (2)

• Relevance of the composite score to predict the clinical outcome at 1 year assessed by the Rankin score, the GOSE and the disability rating scale (DRS).

  one year

• Intra and inter-observer reproducibility study of the analysis of the various sequences.

  during the study

Study Arms (1)

1

Patients in a coma condition after a traumatic brain injury (250), stroke, cerebral anoxia or subarachnoid hemorrhage (150), for at least 7 days.

Procedure: Multimodal MRI

Interventions

Multimodal MRI PROCEDURE

Multimodal MRI

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic brain injured patients, stroke patients, subarachnoid hemorrhage (SAH) patients and cerebral anoxia patients

You may qualify if:

• Adult affiliated to the social security system
• Hospitalized in neuroICU and requiring artificial ventilation following a severe cranial trauma, an ischemic and/or hemorrhagic cerebrovascular accident and/or a cerebral anoxia
• In coma defined as not answering simple orders at least 7 days after the event
• Receiving an amount of sedatives and not being able to explain the coma
• Having a standardized intracranial pressure (≤ 15 mm Hg) and in absence of severe hemodynamic or respiratory failure so that the MRI does not represent any additional danger

You may not qualify if:

• Coma of infectious or toxic origin
• Coma explained by sedation
• MRI contraindication (pace maker, medical material not MRI compatible)
• Persistent intracranial hypertension contraindicating the setting in prolonged dorsal decubitus (ICP \> 20 mm Hg during more than 10 minutes after positioning on decubitus)
• Severe hemodynamic failure
• Severe respiratory failure
• Life threatening extra-cerebral lesions
• Cranial trauma of ballistic origin
• Patient presenting a severe compromise of a major function bringing into play the vital outcome, with invalidity before the accident/event
• Former neurological pathology altering the clinical outcome of the cranial trauma
• Refusal of the family
• Patient protected by the law (under supervision or trusteeship)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hopitaux de Paris Pitie Salpetriere

Paris, 75013, France

Location

Related Publications (4)

• Puybasset L, Perlbarg V, Unrug J, Cassereau D, Galanaud D, Torkomian G, Battisti V, Lefort M, Velly L, Degos V, Citerio G, Bayen E, Pelegrini-Issac M; MRI-COMA Investigators CENTER-TBI MRI Participants and MRI Only Investigators. Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study. Intensive Care Med. 2022 Feb;48(2):201-212. doi: 10.1007/s00134-021-06583-z. Epub 2022 Dec 14.

  PMID: 34904191 DERIVED

• Simeone P, Auzias G, Lefevre J, Takerkart S, Coulon O, Lesimple B, Torkomian G, Battisti V, Jacquens A, Couret D, Naccache L, Bayen E, Bruder N, Perlbarg V, Puybasset L, Velly L. Long-term follow-up of neurodegenerative phenomenon in severe traumatic brain injury using MRI. Ann Phys Rehabil Med. 2022 Nov;65(6):101599. doi: 10.1016/j.rehab.2021.101599. Epub 2022 Feb 15.

  PMID: 34718191 DERIVED

• Velly L, Perlbarg V, Boulier T, Adam N, Delphine S, Luyt CE, Battisti V, Torkomian G, Arbelot C, Chabanne R, Jean B, Di Perri C, Laureys S, Citerio G, Vargiolu A, Rohaut B, Bruder N, Girard N, Silva S, Cottenceau V, Tourdias T, Coulon O, Riou B, Naccache L, Gupta R, Benali H, Galanaud D, Puybasset L; MRI-COMA Investigators. Use of brain diffusion tensor imaging for the prediction of long-term neurological outcomes in patients after cardiac arrest: a multicentre, international, prospective, observational, cohort study. Lancet Neurol. 2018 Apr;17(4):317-326. doi: 10.1016/S1474-4422(18)30027-9. Epub 2018 Feb 27.

  PMID: 29500154 DERIVED

• Luyt CE, Galanaud D, Perlbarg V, Vanhaudenhuyse A, Stevens RD, Gupta R, Besancenot H, Krainik A, Audibert G, Combes A, Chastre J, Benali H, Laureys S, Puybasset L; Neuro Imaging for Coma Emergence and Recovery Consortium. Diffusion tensor imaging to predict long-term outcome after cardiac arrest: a bicentric pilot study. Anesthesiology. 2012 Dec;117(6):1311-21. doi: 10.1097/ALN.0b013e318275148c.

  PMID: 23135257 DERIVED

MeSH Terms

Conditions

Coma; Stroke; Hypoxia, Brain

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory

Study Officials

• Pr Louis Puybasset,, MD, PhD

  Assistance Publique Hopitaux de Paris Pitié Salpetriere

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: October 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2014
• Last Updated: September 21, 2017

Record last verified: 2008-12

Locations

FR (1)