A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage
Intracerebral Hemorrhage, Stroke, Acute, Stroke Hemorrhagic
About this trial
This is an interventional other trial for Intracerebral Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Male or female patients age 22 years and older
- Diagnostic head CT scan within 24 hours of primary spontaneous ICH symptom onset
- ICH >3mL and <90mL, as measured by the ABC method
- 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 schedule for study procedures
Exclusion Criteria:
- Female patients who are pregnant or lactating
- Patients with any history of seizure or 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
- Any intraventricular hemorrhage on the diagnostic (pre-enrollment) CT with planned placement of an intraventricular catheter
- Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
- Planned withdrawal of care within 24 hours of enrollment
- Planned surgical evacuation within 24 hours of enrollment
- Current participation in a medical or surgical interventional clinical trial
- Presence of subdural, epidural or aneurysmal subarachnoid hemorrhage on diagnostic scan
- Planned continued use or prescribed use during the study of medications that, in the investigator's best clinical judgment, are known or suspected to lower the seizure threshold
- Planned continued use of medications that, in the investigator's best clinical judgment, could increase the chances for subsequent uncontrolled hemorrhage
- Planned or current use of continuous EEG monitoring
Sites / Locations
- University of Cincinnati Medical Center
Arms of the Study
Arm 1
Experimental
SENSE Device Monitoring in ICH Patients
The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: A molded plastic headpiece containing the antenna array, and A processing control unit that contains: The driving electronics for the array; A spectrum analyzer coupled with a computer; and, The operating software that controls the device function and data acquisition, processing and archiving. For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.