An interventional study of Spinal Cord Stimulation in Spinal Cord Injury Cervical, Spinal Cord Injuries (SCI) and Spinal Cord Injury (SCI), Initial Encounter, sponsored by Markey Olson. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Markey Olson · Not applicable, Interventional, and Supportive care
In the treatment of spinal cord injury (SCI) patients in the hyperacute setting, it is imperative to closely control mean arterial pressure (MAP) to ensure adequate spinal cord perfusion in the absence of properly functioning autonomic innervation. Standards of care in literature have historically been to maintain a mean arterial pressure of 85-90 mmHg for 5-7 days after injury. Currently in the ICU setting, this is typically performed using intravenous vasopressors like norepinephrine. Although effective, vasopressors carry risks including arrhythmias, peripheral ischemia, and prolonged ICU management.
Transcutaneous spinal cord stimulation (tSCS) has emerged as an alternative method for blood pressure augmentation in SCI patients, recently completing a clinical trial in chronic SCI patients with incredibly promising results. tSCS has yet to be trialed in the ICU setting, but it is expected that patient response should be similar to the chronic setting. This prospective feasibility study will evaluate whether tSCS can acutely increase MAP in adults with acute traumatic SCI admitted to the ICU. During a single study session, participants will receive transcutaneous stimulation while standard vasopressor therapy is maintained at a constant dose. A neurocritical care physician will be present throughout testing to ensure patient safety and standard clinical management.
The primary objective is to determine the feasibility and acute hemodynamic effects of tSCS in this population. Primary outcome measures include change in MAP from baseline and time to hemodynamic response following stimulation. Secondary outcomes include changes in heart rate, stimulation tolerability, adverse events, and participant-reported comfort and overall experience. Data collected from this feasibility study will be used to assess the safety and practicality of implementing tSCS in the hyperacute SCI setting and to inform the design of future clinical trials evaluating tSCS as an adjunct or alternative strategy for blood pressure augmentation in critically ill SCI patients.
1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's planned enrollment of 20 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries 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:
Participants will undergo a single transcutaneous spinal cord stimulation (tSCS) study session while remaining on standard ICU management. Adhesive stimulation electrodes will be positioned over the T9 vertebral level with anterior return electrodes placed according to previously published protocols for blood pressure augmentation using tSCS. Vasopressor dosing will remain constant throughout the stimulation protocol unless a change is clinically required by the treating neurocritical care physician. Continuous arterial blood pressure monitoring will be used for all hemodynamic measurements. Following a ten-minute baseline recording period, stimulation will be initiated and maintained for up to ten minutes. Continuous MAP and heart rate will be recorded before, during, and after stimulation.
Device: Spinal Cord Stimulation
Participants will undergo a single transcutaneous spinal cord stimulation (tSCS) study session while remaining on standard ICU management. Adhesive stimulation electrodes will be positioned over the T9 vertebral level with anterior return electrodes placed according to previously published protocols for blood pressure augmentation using tSCS. Vasopressor dosing will remain constant throughout the stimulation protocol unless a change is clinically required by the treating neurocritical care physician. Continuous arterial blood pressure monitoring will be used for all hemodynamic measurements. Following a ten-minute baseline recording period, stimulation will be initiated and maintained for up to ten minutes. Continuous MAP and heart rate will be recorded before, during, and after stimulation.
Change in MAP from baseline
Time frame: Periprocedural
Time required to achieve peak MAP response
Time frame: Periprocedural
Change in heart rate per minute
Time frame: Periprocedural
Duration of MAP elevation
Time frame: Periprocedural
Stimulation tolerability (measured via NRS/VRS)
Patients will relate tolerability via NRS scale 0-10 and via verbal description
Time frame: Periprocedural
Device related adverse events
Time frame: Periprocedural
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Markey Olson