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A Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale
Sponsor: Markey Olson
Summary
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).
Official title: A Prospective, Two-phase, Dose-response and Efficacy Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-10-31
Completion Date
2025-12-31
Last Updated
2024-11-08
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous electrical stimulation
Transcutaneous electrical stimulation will be used to create noxious stimuli for the GCS exam
Standard of Care (SOC)
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.
Locations (1)
Barrow Neurological Institute
Phoenix, Arizona, United States