NCT06681779

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

A Prospective, Two-phase, Dose-response and Efficacy Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Markey Olson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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, and toe. Stimulation will be applied to one area at a time by connecting the electrode to a stimulator. For each physical and electrical stimulation, response will be measured (such as flinching, opening eyes, making sounds, etc.). The goal is to create electrical stimulation patterns that cause the same response as the physical exam without causing any physical damage. A video recording will also be taken of the participant's telemetry unit (the screen showing their heart rate and other vital signs throughout the study. This video, in addition to the information from the participant's medical record, is to make sure that there are no unexpected changes in vital signs during the study. The participant will not be visible on this video.

Conditions

• Comatose

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study