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:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT07077135
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old;
* any acquired cerebral damage of any known etiology;
* diagnosis of coma, UWS, or MCS with the corresponding basal CRS-R (Coma Recovery Scale-Revised) score performed during the screening period from 7 to 15 days since admission in ICU;
* intact ear skin;
* availability of the device.
Exclusion Criteria:
* Patients with severe hemodynamic, respiratory, infectious, or neurological instability requiring active treatment requiring mechanical ventilation or vasoactive drugs or pending acute neurosurgical interventions;
* Need for deep sedation, including general anesthetics (e.g., propofol) or a combination of central-acting sedatives;
* Documented pregnancy;
* Active implant (e.g., pacemaker, cochlear implant);
* History of previous serious neurological disability before the brain injury;
* Seizures or status epilepticus as cause sustaining the disorder of consciousness;
* Patients already enrolled in another ongoing interventional trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07077135
Study Brief:
Protocol Section:
NCT07077135