A Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale (GCS02)

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Comatose
• Intervention / Treatment: Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 frequency or extent of neurologic assessments is being limited due to concern that noxious stimulation may provoke intracranial hypertension, cardiorespiratory instability, or other adverse events
3. Patients with an implantable or external pacemaker that is currently in use
4. Ongoing refractory cardiorespiratory instability
5. Pregnant females
6. Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E2; Patients with a stable GCS subscore of E2, eyes opening to pain	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.
Experimental: E1; Patients with a stable GCS subscore of E2, eyes non-responsive to pain	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.
Experimental: Upper Extremity M5; Patients with a stable GCS subscore of M5, localizing, in at least one upper limb	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.
Experimental: Upper Extremity M4; Patients with a stable GCS subscore of M4, withdrawing, in at least one upper limb	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.
Experimental: Upper Extremity M3; Patients with a stable GCS subscore of M3, flexing, in at least one upper limb	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.
Experimental: Upper Extremity M2; Patients with a stable GCS subscore of M2, extending, in at least one upper limb	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.
Experimental: Upper Extremity M1; Patients with a stable GCS subscore of M1, no response to stimuli, in at least one upper limb	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.
Experimental: Lower Extremity M4; Patients with a stable GCS subscore of M4, withdrawing, in at least one lower limb	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.
Experimental: Lower Extremity M3; Patients with a stable GCS subscore of M3, flexing, in at least one lower limb	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.
Experimental: Lower Extremity M1; Patients with a stable GCS subscore of M1, no response, in at least one lower limb	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Transcutaneous Stimulation Glascow Coma Scale (Exams) score with traditional SOC	Two GCS exams will be conducted at the same time point, and it will be determined whether the same score is obtained for both methods.	Less than 24 hours

Collaborators and Investigators

• Sponsor: Markey Olson
• Investigators: Study Director: Brandon M Fox, MD, PhD, Barrow Neurological Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Coma; Transcutaneous stimulation; Glasgow Coma Scale
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Coma
• Other Study ID Numbers: 24-500-265-30-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No