Early Feasibility Study of the SENSE Device

Completed · Not applicable

Conditions studied: Hemorrhagic Stroke, Ischemic Stroke

In brief

A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset.

Key facts

Study ID

NCT03827720

Run by

Sense Diagnostics, LLC

People needed

20

Starts

2019-06-06

Expected to finish

2021-01-04

Last updated by the study team

2021-07-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female patients age 22 years and older
• Established diagnosis of AIS (with or without LVO) or ICH within 24 hours of symptom onset
• Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian
• Willingness and ability to comply with 45 minutes of SENSE monitoring per study procedures
• Attending (Treating) physician has indicated that the patient is stable and has approved the patient's participation in the study

You may not qualify if…

• Female patients who are pregnant or lactating
• Patients with a known seizure disorder or those who have a seizure at stroke onset
• 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
• Intraventricular hemorrhage requiring emergent ventriculostomy placement on the eligibility CT or MRI
• Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
• Pontine or infratentorial location of ICH
• In AIS patients, treatment with intravenous alteplase and/or mechanical thrombectomy prior to the initiation of 45 minutes of SENSE monitoring
• Current participation in an interventional clinical trial

Where it is running

• TriHealth Hatton Research Institute - Good Samaritan Hospital — Cincinnati, Ohio, United States
• UC Health — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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