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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2 | Experimental | Patients with a stable GCS subscore of E2, eyes opening to pain |
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| E1 | Experimental | Patients with a stable GCS subscore of E2, eyes non-responsive to pain |
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| Upper Extremity M5 | Experimental | Patients with a stable GCS subscore of M5, localizing, in at least one upper limb |
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| Upper Extremity M4 | Experimental | Patients with a stable GCS subscore of M4, withdrawing, in at least one upper limb |
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| Upper Extremity M3 | Experimental | Patients with a stable GCS subscore of M3, flexing, in at least one upper limb |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical stimulation | Device | Transcutaneous electrical stimulation will be used to create noxious stimuli for the GCS exam |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon M Fox, MD, PhD | Barrow Neurological Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States |
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| ID | Term |
|---|---|
| D003128 | Coma |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Upper Extremity M2 | Experimental | Patients with a stable GCS subscore of M2, extending, in at least one upper limb |
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| Upper Extremity M1 | Experimental | Patients with a stable GCS subscore of M1, no response to stimuli, in at least one upper limb |
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| Lower Extremity M4 | Experimental | Patients with a stable GCS subscore of M4, withdrawing, in at least one lower limb |
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| Lower Extremity M3 | Experimental | Patients with a stable GCS subscore of M3, flexing, in at least one lower limb |
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| Lower Extremity M1 | Experimental | Patients with a stable GCS subscore of M1, no response, in at least one lower limb |
|
| 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. |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |