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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT07209657
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a severe ABI, as indicated by at least one of the following:
* Glasgow Coma Scale (GCS) 3-8 at admission to RCH
* Mass pathology evident on neuroimaging
* Expert opinion of treating consultant
* Diagnosis of a DoC, as indicated by at least one of the following:
* Rancho Los Amigos Scale I, II, III or IV
* Expert opinion of treating consultant
* Legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Interpreters will be employed as necessary.
Exclusion Criteria:
* ABI not compatible with life/child expected to die
* ABI resulting from suspected non-accidental causes, including assault/abuse
* Diagnosed premorbid or acquired severe hearing loss
* Inability or unwillingness of legally acceptable representative to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT07209657
Study Brief:
Protocol Section:
NCT07209657