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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT04244058
Eligibility Criteria:
Patients Subjects with DOC
Inclusion criteria:
* Age between 18 and 75 years of age, inclusive.
* Patients with disorder of consciousness (vegetative state, minimally conscious state, emerged from minimally conscious state) following severe brain injuries.
* Male or non-pregnant female.
* Medically stable.
* Informed consent from a Legally Authorized Representative.
Exclusion criteria:
* Medical instability.
* Clinical history of moderate to severe hypertension or heart arrhythmia.
* Use of stimulants or dopamine blocker during the 24 hours previous to the study.
* Absence of a legally authorized representative (LAR) to sign the consent form.
Normal Volunteers
Inclusion criteria:
* Age between 18 and 75 years old, inclusive.
* Absence of cardiological, neurological and/or psychiatric diseases.
* Absence of familiar antecedents of sudden death of unknown reason.
* Male or non-pregnant female.
* Informed consent signed.
Exclusion criteria:
\- Caffeine or alcohol intake in the last 24 hours previous to the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04244058
Study Brief:
Protocol Section:
NCT04244058