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ENROLLING BY INVITATION
NCT06681779
NA

A Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale

Sponsor: Markey Olson

View on ClinicalTrials.gov

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

DEVICE

Transcutaneous electrical stimulation

Transcutaneous electrical stimulation will be used to create noxious stimuli for the GCS exam

OTHER

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