Intracranial Hemorrhage – SENSE-003

Name: SENSE-003 (Evaluate the SENSE-003 Device’s Ability to Monitor Intracranial Hemorrhage)

Contact: Dr. Pouya Ameli (PI) and Magali Jorand-Fletcher (Lead CRC) (352) 294-5391

Enrolling hours: Paused

Diagnosis: ICH

Inclusion:

Subjects who meet all of the following inclusion criteria will be considered candidates for study enrollment:

• • Male or female patients age 22 years and older
  • CT obtained in the mobile stroke unit, emergency department (ED) or hospital
  • Informed consent provided by study subject or, if subject is unable, by subject’s next of kin or legal guardian

Exclusion:

All subjects meeting any of the following criteria will be excluded from this study:

• • Female patients who are pregnant or lactating
  • SENSE device cannot be applied within 6 hours of a standard of care CT
  • Metallic intracranial clip, coil, device (such as ICP monitor), or penetrating metallic shrapnel.
  • Metallic EEG leads in place at the time of planned enrollment.
  • Open skull fracture (closed skull fracture is not an exclusion).
  • Placement of an intraventricular catheter prior to enrollment.
  • Hemorrhagic transformation of ischemic stroke as etiology of ICH.
  • Treatment with intravenous thrombolysis or embolectomy prior to enrollment.
  • Clinical uncertainty about whether intracranial hemorrhage is present on the enrolling head CT.
  • Presence or history of any other condition or finding that, in the investigator’ opinion, makes the patient unsuitable as a candidate for SENSE device monitoring or study participation or may confound the outcome of the study.