An interventional study of Transcutaneous electrical stimulation and Standard of Care (SOC) in Comatose, sponsored by Markey Olson. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Markey Olson · Not applicable, Interventional, and Diagnostic
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.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's planned enrollment of 90 is close to the median of 85 across 77 interventional studies indexed under Coma.
Browse Coma studies →Markey Olson is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a stable GCS subscore of E2, eyes opening to pain
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Patients with a stable GCS subscore of E2, eyes non-responsive to pain
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Patients with a stable GCS subscore of M5, localizing, in at least one upper limb
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Patients with a stable GCS subscore of M4, withdrawing, in at least one upper limb
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Patients with a stable GCS subscore of M3, flexing, in at least one upper limb
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Patients with a stable GCS subscore of M2, extending, in at least one upper limb
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
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Patients with a stable GCS subscore of M4, withdrawing, in at least one lower limb
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Patients with a stable GCS subscore of M3, flexing, in at least one lower limb
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
Device: Transcutaneous electrical stimulation · Other: Standard of Care (SOC)
Transcutaneous electrical stimulation will be used to create noxious stimuli for the GCS exam
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.
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.
Time frame: Less than 24 hours
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2025, 14 months after the start.
Of 39 non-industry interventional studies with no phase under Coma, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's planned 14 months is below that.
Counting every sponsor, half of 39 studies reached it within 39 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Markey Olson