Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03494218
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 18 years old;
* no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
* the presence of periods of eye opening (indicating wakefulness and rest cycles);
* a diagnosis of VS or MCS, based on more than 4 times behavioral assessment performed using the Coma Recovery Scale-Revised within 2 weeks.
Exclusion Criteria:
* Coma;
* documented history of prior brain injury;
* psychiatric or neurologic illness;
* neuromuscular blocking agents or sedative drugs administered within the prior 24 hours;
* no documented history of a prior coma, critical illness or unstable medical condition;
* upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores \<1).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
53 Years
Study:
NCT03494218
Study Brief:
Protocol Section:
NCT03494218