Markey Olson
The purpose of this study is to determine whether electrical stimulation can be used to replace physical stimulation to test awareness of patients with impaired consciousness. Physical stimulation can cause bruising, damaged nails and ribs, and other damage with repeated testing, and electrical stimulation may be safer and cause less distress with time. This device has not been approved by the U.S. Food and Drug Administration (FDA).
For patients enrolled in this study, the study doctor or study staff will give non-invasive electrical stimulation to measure response. Depending on what study group, the study team may apply this stimulation several times at one (Phase 1) or two (Phase 2) separate time points approximately 2 hours apart (when GCS would normally be collected as part of clinical care). In addition to GCS using normal physical stimulation, the study team will test responses to electrical stimulation. To do this, electrodes (special wired stickers that conduct electricity) will be placed on the forehead, finger,…
Inclusion Criteria: 1. Patient is admitted to the Barrow Neurological Institute's neuro ICU 2. Patient is in a comatose state, which is defined as a patient who is both non-responsive and has a GCS eye or motor response sub-score that requires noxious stimulation 3. Age greater than or equal to 18 years 4. Patient has an available surrogate decision maker with the capacity to consent for participation in a research study Exclusion Criteria: 1. A neurologic decline immediately prior to study participation that requires urgent or emergent workup or management\* 2. Patients in whom the frequen…
Transcutaneous electrical stimulation will be used to create noxious stimuli for the GCS exam
Physical pain stimulation, as used in traditional standard care, will be used to score the GCS exam, and the device results will be compared to this SOC exam.
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