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

Conditions

• Comatose

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Transcutaneous electrical stimulation — DEVICE
  Transcutaneous electrical stimulation will be used to create noxious stimuli for the GCS exam
• 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.

Study Details

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).

Key Dates

Start date

Oct 31, 2024

Status verified

Nov 2024

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

90 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Arms

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

Primary Outcome Measure

Comparison of Transcutaneous Stimulation Glascow Coma Scale (Exams) score with traditional SOC [ Time Frame: Less than 24 hours ]

Locations (1)

Find similar trials in Phoenix, AZ

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