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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT07119827
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of one of the following two conditions:
* Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology; the term sABI includes acute brain injuries of traumatic or non-traumatic origin (vascular, infectious, metabolic, or anoxic), in which the patient initially presents with a coma state (Glasgow Coma Scale - GCS less than 8) and simultaneously exhibits motor, sensory, cognitive, and/or behavioral impairments.
* Ischemic or hemorrhagic stroke without features of Severe Acquired Brain Injury (sABI) (Glasgow Coma Scale \[GCS\] score ≥ 8 and no alteration of consciousness).
* Time from injury between:
* 7 and 90 days for Severe Acquired Brain Injury (sABI) patients
* 3 and 30 days for stroke patients
* Level of Cognitive Functioning (LCF) score ≥ 6 for sABI patients
* Signed informed consent for study participation
* Presence of a support family member (caregiver) able to assist with completing the personality questionnaire (HEXACO Adjective Scale, HAS)
Exclusion Criteria:
* Pre-existing neurological pathology
* Severe aphasia or severe inattention that precludes administration of the tests required by the protocol, as identified during cognitive screening.
* Patients with a language barrier due to insufficient proficiency in Italian.
* Particularly vulnerable populations:
The following patients will be excluded from the study: patients in emergency situations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07119827
Study Brief:
Protocol Section:
NCT07119827