Name: SENSE (Evaluate the SENSE Device’s Ability to Monitor Intracranial Hemorrhage)
Contact: Ralisa Pop (Lead CRC 352-273-5550 x45693), Dr. Pouya Ameli (PI)
Enrolling hours: M-F 8-5PM
Diagnosis: ICH
Inclusion:
- Male or female patients age 22 years and older
- Diagnostic head CT scan within 6 hours of primary spontaneous ICH (parenchymal ICH without secondary causes, such as arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation of ischemic stroke, venous sinus thrombosis) symptom onset or traumatic intracranial bleeding (defined as epidural hemorrhage, subdural hemorrhage and/or traumatic contusions/ intraparenchymal hemorrhage)
- Able to have device placed within 6 hours of onset of primary spontaneous ICH.
- 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:
- Female patients who are pregnant or lactating
- Known history of seizure or clinical seizure prior to initiating SENSE monitoring 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
- Planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) CT
- In stroke patients, secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis)
- 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
- Planned or current use of continuous EEG monitoring