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

NCT06681779 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 24-500-265-30-06
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Comatose

Keywords

Glasgow Coma Scale; Coma; Transcutaneous stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (10)

E2

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

E1

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Upper Extremity M5

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Upper Extremity M4

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Upper Extremity M3

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Upper Extremity M2

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Upper Extremity M1

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Lower Extremity M4

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Lower Extremity M3

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Lower Extremity M1

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC)

Interventions

Transcutaneous electrical stimulation DEVICE

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

E1; E2; Lower Extremity M1; Lower Extremity M3; Lower Extremity M4; Upper Extremity M1; Upper Extremity M2; Upper Extremity M3; Upper Extremity M4; Upper Extremity M5

Standard of Care (SOC) 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; E2; Lower Extremity M1; Lower Extremity M3; Lower Extremity M4; Upper Extremity M1; Upper Extremity M2; Upper Extremity M3; Upper Extremity M4; Upper Extremity M5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is admitted to the Barrow Neurological Institute's neuro ICU
• 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
• Age greater than or equal to 18 years
• Patient has an available surrogate decision maker with the capacity to consent for participation in a research study

You may not qualify if:

• A neurologic decline immediately prior to study participation that requires urgent or emergent workup or management\*
• 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
• Patients with an implantable or external pacemaker that is currently in use
• Ongoing refractory cardiorespiratory instability
• Pregnant females
• Prisoners

Sponsors & Collaborators

• Markey Olson: lead

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Coma

Interventions

Transcutaneous Electric Nerve Stimulation; Standard of Care

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Brandon M Fox, MD, PhD

  Barrow Neurological Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Manager

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: October 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)