Consciousness Disorder Clinical Trial
— M-Neuro-DoCOfficial title:
Multimodal Neuroprognostication in Disorders of Consciousness
NCT number | NCT04534777 |
Other study ID # | APHP 200194 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 9, 2020 |
Est. completion date | May 2027 |
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
Status | Recruiting |
Enrollment | 500 |
Est. completion date | May 2027 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Pitié Salpétrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Andre-Obadia N, Zyss J, Gavaret M, Lefaucheur JP, Azabou E, Boulogne S, Guerit JM, McGonigal A, Merle P, Mutschler V, Naccache L, Sabourdy C, Trebuchon A, Tyvaert L, Vercueil L, Rohaut B, Delval A. Recommendations for the use of electroencephalography and evoked potentials in comatose patients. Neurophysiol Clin. 2018 Jun;48(3):143-169. doi: 10.1016/j.neucli.2018.05.038. Epub 2018 May 18. — View Citation
Balanca B, Dailler F, Boulogne S, Ritzenthaler T, Gobert F, Rheims S, Andre-Obadia N. Diagnostic accuracy of quantitative EEG to detect delayed cerebral ischemia after subarachnoid hemorrhage: A preliminary study. Clin Neurophysiol. 2018 Sep;129(9):1926-1936. doi: 10.1016/j.clinph.2018.06.013. Epub 2018 Jul 5. — View Citation
Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498. — View Citation
Hermann B, Goudard G, Courcoux K, Valente M, Labat S, Despois L, Bourmaleau J, Richard-Gilis L, Faugeras F, Demeret S, Sitt JD, Naccache L, Rohaut B; Pitie-Salpetriere hospital Neuro-ICU. Wisdom of the caregivers: pooling individual subjective reports to diagnose states of consciousness in brain-injured patients, a monocentric prospective study. BMJ Open. 2019 Feb 21;9(2):e026211. doi: 10.1136/bmjopen-2018-026211. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prognosis accuracy of respective predictive markers of consciousness recovery | 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). | 24 MONTHS | |
Secondary | GOS-E Glasgow outcome scale - Extended | Evolution of GOS-E (Glasgow outcome scale - Extended) scale from category 1 ==> Death to category 8: good recovery upper ==>no current problems related to the brain injury that affect daily life | 6, 12 and 18 months |
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