Multimodal Neuroprognostication in Disorders of Consciousness

NCT04534777 | Recruiting

• 1 other identifier: APHP 200194
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Consciousness Disorder

Keywords

electroencephalography; evoked potentials; functional magnetic resonance imaging; minimally conscious state; positron emission tomography; resting state fMRI (functional magnetic resonance imaging ); transcranial magnetic stimulation; traumatic brain injury; unresponsive wakefulness syndrome; vegetative state; polysomnography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• GOS-E Glasgow outcome scale - Extended

  6, 12 and 18 months

Study Arms (1)

Consciousness disorder patients

The overall outcome of this project will allow to draw better single-patient predictions of state, prognosis, and rehabilitation strategies and furthermore, a better understanding the pathophysiological mechanisms behind DoC that could result in groundbreaking new personalized therapeutic approaches. 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.

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

Interventions

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

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.

Consciousness disorder patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery) or with Brain injuries on CT or MRI

You may qualify if:

• Consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery)
• Brain injuries on CT or MRI (e.g. TBI) (traumatic brain-injured ), anoxia or stroke related lesions, etc…)
• Age between 18 and 80 years

You may not qualify if:

• Deep sedation (e.g. elevated ICP(intracranial pressure ), refractory status epilepticus)
• Sever known neurodegenerative disease (e.g. Alzheimer disease)
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpétrière

Paris, 75013, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 16350959 BACKGROUND

• 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.

  PMID: 30792234 BACKGROUND

• 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.

  PMID: 29784540 BACKGROUND

• 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.

  PMID: 30007892 BACKGROUND

• Rohaut B, Calligaris C, Hermann B, Perez P, Faugeras F, Raimondo F, King JR, Engemann D, Marois C, Le Guennec L, Di Meglio L, Sangare A, Munoz Musat E, Valente M, Ben Salah A, Demertzi A, Belloli L, Manasova D, Jodaitis L, Habert MO, Lambrecq V, Pyatigorskaya N, Galanaud D, Puybasset L, Weiss N, Demeret S, Lejeune FX, Sitt JD, Naccache L. Multimodal assessment improves neuroprognosis performance in clinically unresponsive critical-care patients with brain injury. Nat Med. 2024 Aug;30(8):2349-2355. doi: 10.1038/s41591-024-03019-1. Epub 2024 May 30.

  PMID: 38816609 DERIVED

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State; Brain Injuries, Traumatic

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Central Study Contacts

Benjamin ROHAUT, MD

CONTACT

184827888; benjamin.rohaut@aphp.fr

Lionel NACCACHE, PUPH

CONTACT

157274314; lionel.naccache@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: September 1, 2020
• Study Start: September 9, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

FR (1)