Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation Immediately After Spinal Cord Injury

NCT07887373 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 27-500-066-70-06
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Cord Injury Cervical; Spinal Cord Injuries (SCI); Spinal Cord Injury (SCI), Initial Encounter

Keywords

spinal cord injury; blood pressure; autonomic function; spinal cord stimulation

Outcome Measures

Primary Outcomes (2)

• Change in MAP from baseline

  Periprocedural

• Time required to achieve peak MAP response

  Periprocedural

Secondary Outcomes (4)

• Change in heart rate per minute

  Periprocedural

• Duration of MAP elevation

  Periprocedural

• Stimulation tolerability (measured via NRS/VRS)

  Periprocedural

• Device related adverse events

  Periprocedural

Study Arms (1)

Spinal Cord Stimulation

EXPERIMENTAL

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

Interventions

Spinal Cord Stimulation DEVICE

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.

Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to undergo tSCS testing without interruption of clinically indicated treatment
• age ≥18 years
• confirmed acute traumatic SCI
• ICU admission
• ongoing arterial blood pressure monitoring
• and treating physician approval for participation

You may not qualify if:

• hemodynamic instability requiring active vasopressor escalation
• unstable cardiac arrhythmia, implanted electrical devices such as pacemakers or defibrillators
• open wounds or skin breakdown at electrode sites
• pregnancy
• inability to safely position stimulation electrodes
• or any condition judged by the treating team to make participation unsafe

Sponsors & Collaborators

• Markey Olson: lead
• Cervical Spine Research Society: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Markey Olson, PhD

CONTACT

602-406-5944; neuromodulationresearch@commonspirit.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Manager

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share