ComatoseGCS02NCT06681779
A Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale
A study testing Transcutaneous electrical stimulation in people with Comatose, run by Markey Olson at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comatose
- What is being tested?
- Transcutaneous electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: 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).
Read the 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
- Being tested
- Transcutaneous electrical stimulation, Standard of Care (SOC)
- Keywords
- Glasgow Coma Scale, Coma, Transcutaneous stimulation
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| E2 | Experimental | Patients with a stable GCS subscore of E2, eyes opening to pain Receives: Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC) |
| E1 | Experimental | Patients with a stable GCS subscore of E2, eyes non-responsive to pain Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: Transcutaneous electrical stimulation; Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Less than 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start31 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComatoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Markey Olson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Markey Olson, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Brandon M Fox, MD, PhD, Study director, Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681779
- Sponsor's protocol ID
- 24-500-265-30-06
- Acronym
- GCS02
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Two-phase, Dose-response and Efficacy Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale
- ClinicalTrials.gov ID
- NCT06681779
- Acronym / sponsor ID
- GCS02 / 24-500-265-30-06
- Conditions
- Comatose
- Keywords
- Glasgow Coma Scale, Coma, Transcutaneous stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Markey OlsonUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| E2 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of E2, eyes opening to pain |
| E1 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of E2, eyes non-responsive to pain |
| Upper Extremity M5 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M5, localizing, in at least one upper limb |
| Upper Extremity M4 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M4, withdrawing, in at least one upper limb |
| Upper Extremity M3 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M3, flexing, in at least one upper limb |
| Upper Extremity M2 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M2, extending, in at least one upper limb |
| Upper Extremity M1 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M1, no response to stimuli, in at least one upper limb |
| Lower Extremity M4 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M4, withdrawing, in at least one lower limb |
| Lower Extremity M3 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M3, flexing, in at least one lower limb |
| Lower Extremity M1 | Experimental | Device: Transcutaneous electrical stimulation, Other: Standard of Care (SOC)Patients with a stable GCS subscore of M1, no response, in at least one lower limb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical stimulationTranscutaneous electrical stimulation will be used to create noxious stimuli for the GCS exam | Device | 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)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. | Other | 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 |
Primary outcome
Comparison of Transcutaneous Stimulation Glascow Coma Scale (Exams) score with traditional SOC
Time frame: Less than 24 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon M Fox, MD, PhD study director
Barrow Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical stimulation in people with Comatose, run by Markey Olson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Transcutaneous Stimulation Glascow Coma Scale (Exams) score with traditional SOC (time frame: Less than 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.