Evaluate the SENSE Device's Ability to Monitor Intracranial Hemorrhage
Evaluate the SENSE Device's Ability to Monitor Intracranial Hemorrhage
This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient
 comparison of the SENSE device and the standard diagnostic test, head CT scan in patients
 with a diagnosis of primary spontaneous ICH or traumatic intracranial bleeding for the
 detection and monitoring of intracranial hemorrhages.
This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient
 comparison of the SENSE device and the standard diagnostic test, head CT scan in patients
 with a diagnosis of primary spontaneous ICH (parenchymal ICH without secondary causes, such
 as arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation of ischemic
 stroke, venous sinus thrombosis) or traumatic intracranial bleeding (defined as epidural
 hemorrhage, subdural hemorrhage and/or traumatic contusions/intraparenchymal hemorrhage) for
 the detection and monitoring of intracranial hemorrhages. All subjects with any spontaneous
 or traumatic ICH who meet eligibility criteria should be enrolled. We anticipate that some
 TBI patients with traumatic ICH may not have a prolonged hospital stay and the standard
 practice in these patients who do not experience hemorrhage expansion is to obtain a head CT
 within 6-24 hours. It is anticipated that the majority of subjects admitted to the hospital,
 i.e., spontaneous ICH or TBI patients who experience hemorrhage expansion, will be managed in
 an intensive care unit (ICU). Mild TBI with traumatic ICH patients may be managed outside of
 an ICU depending on local practice. The SENSE device will be evaluated in subjects at risk of
 early and delayed hemorrhage expansion.
Inclusion Criteria:

 -  Male or female patients age 22 years and older

 -  Diagnostic head CT scan within 24 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)

 -  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

 -  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