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

NCT06681779 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-11-08

No results posted yet for this study

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).

Conditions

  • Comatose

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.

Sponsors & Collaborators

  • Markey Olson

    lead OTHER

Principal Investigators

  • Brandon M Fox, MD, PhD · Barrow Neurological Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06681779 on ClinicalTrials.gov