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

NCT ID: NCT06681779

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

E2

Patients with a stable GCS subscore of E2, eyes opening to pain

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

E1

Patients with a stable GCS subscore of E2, eyes non-responsive to pain

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Upper Extremity M5

Patients with a stable GCS subscore of M5, localizing, in at least one upper limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Upper Extremity M4

Patients with a stable GCS subscore of M4, withdrawing, in at least one upper limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Upper Extremity M3

Patients with a stable GCS subscore of M3, flexing, in at least one upper limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Upper Extremity M2

Patients with a stable GCS subscore of M2, extending, in at least one upper limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Upper Extremity M1

Patients with a stable GCS subscore of M1, no response to stimuli, in at least one upper limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Lower Extremity M4

Patients with a stable GCS subscore of M4, withdrawing, in at least one lower limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Lower Extremity M3

Patients with a stable GCS subscore of M3, flexing, in at least one lower limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Lower Extremity M1

Patients with a stable GCS subscore of M1, no response, in at least one lower limb

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Standard of Care (SOC)

Intervention Type: OTHER

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.

Interventions

Transcutaneous electrical stimulation

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Markey Olson

OTHER

Sponsor Role: lead

Responsible Party

Markey Olson

Program Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brandon M Fox, MD, PhD

Role: STUDY_DIRECTOR

Barrow Neurological Institute

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

24-500-265-30-06

Identifier Type: -

Identifier Source: org_study_id