Multimodal Assessment and Prognosis in Disorders of Consciousness After Severe Brain Injury (CyDoC-MAP)

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Conditions studied: Consciousness Disorders, Persistent Vegetative State, Unresponsive Wakefulness Syndrome, Minimally Conscious State, Coma; Prolonged, Brain Injuries, Traumatic, Cerebral Hemorrhage, Subarachnoid Hemorrhage

In brief

After a severe brain injury some patients survive but cannot communicate, and deciding early which of them are likely to recover consciousness remains one of the hardest problems in neurocritical care. Bedside examination alone misclassifies a substantial proportion of these patients. CyDoC-MAP is a single-centre, prospective, observational cohort study conducted at Nicosia General Hospital, the sole trauma referral centre for Cyprus. It enrols patients aged 16 years or older who are intubated within 24 hours of a moderate-to-severe traumatic brain injury or a haemorrhagic stroke (intracerebral or subarachnoid haemorrhage), and who are subsequently classified as being in a vegetative state / unresponsive wakefulness syndrome (VS/UWS) or a minimally conscious state (MCS) on the Coma Recovery Scale-Revised (CRS-R). Four assessment modalities are recorded: (1) the CRS-R, performed at least twice with an interval of at least 48 hours; (2) serum neuron-specific enolase (NSE) sampled within 24 hours of intubation; (3) the bispectral index (BIS), recorded at least twice with an interval of at least 48 hours, after five minutes of standardised noxious and auditory stimulation; and (4) in the traumatic subgroup only, 1.5 T magnetic resonance imaging performed 7-28 days after injury and graded 1-4 by lesion depth by two independent raters. Level of consciousness is reassessed with the CRS-R 6 to 12 months after the index event, and the total CRS-R score (0-23) at that reassessment is the primary outcome. The primary aim is to estimate the strength of the association between the bispectral index recorded on the ward and that later CRS-R score, and to quantify what the bispectral index adds beyond the baseline clinical assessment. The number of eligible patients at a single national centre does not support the development of a prognostic model; the study is designed to produce effect-size estimates with confidence intervals that will inform a subsequent multicentre study. The study is purely observational. No intervention is administered, no study procedure alters clinical management, and transfer to rehabilitation is never delayed for research purposes.

Key facts

Study ID: NCT07736820
Run by: Nicosia General Hospital
People needed: 40
Starts: 2026-09-15
Expected to finish: 2030-09-30
Last updated by the study team: 2026-07-30

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Inclusion Criteria:
Age 16 years or older
Moderate-to-severe traumatic brain injury, or haemorrhagic stroke (intracerebral or subarachnoid haemorrhage)
Intubation for a reduced level of consciousness within 24 hours of the index event
Admitted to, or transferred to, Nicosia General Hospital
Classified as VS/UWS or MCS on the Coma Recovery Scale-Revised after discharge from the intensive care unit
Written informed consent obtained from the next of kin (and from a legal guardian for participants aged 16-17)

You may not qualify if…

Severe pre-existing psychiatric disorder
History of ischaemic or haemorrhagic stroke
Pre-existing dementia
Reduction in Glasgow Coma Scale attributable to sedation or intoxicating substances
Reduction in Glasgow Coma Scale attributable to severe extracranial injury (massive haemorrhage, generalised hypoxia)
End-stage disease with a life expectancy of less than 6 months

Where it is running

Nicosia General Hospital, Department of Neurosurgery — Nicosia, Cyprus

Full record on ClinicalTrials.gov

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