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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03827720
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients age 22 years and older
2. Established diagnosis of AIS (with or without LVO) or ICH within 24 hours of symptom onset
3. Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian
4. Willingness and ability to comply with 45 minutes of SENSE monitoring per study procedures
5. Attending (Treating) physician has indicated that the patient is stable and has approved the patient's participation in the study
Exclusion Criteria:
1. Female patients who are pregnant or lactating
2. Patients with a known seizure disorder or those who have a seizure at stroke onset
3. Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study
4. Intraventricular hemorrhage requiring emergent ventriculostomy placement on the eligibility CT or MRI
5. Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
6. Pontine or infratentorial location of ICH
7. In AIS patients, treatment with intravenous alteplase and/or mechanical thrombectomy prior to the initiation of 45 minutes of SENSE monitoring
8. Current participation in an interventional clinical trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03827720
Study Brief:
Protocol Section:
NCT03827720