Spinal Cord Injury CervicalStim for MAPNCT07887373
Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation Immediately After Spinal Cord Injury
A study testing Spinal Cord Stimulation in people with Spinal Cord Injury Cervical and Spinal Cord Injuries (SCI), run by Markey Olson.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury Cervical, Spinal Cord Injuries (SCI), Spinal Cord Injury (SCI), Initial Encounter
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Dec 2027
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation in the Hyperacute Setting of Spinal Cord Injury, a Feasibility Trial
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
- Being tested
- Spinal Cord Stimulation
- Keywords
- spinal cord injury, blood pressure, autonomic function, spinal cord stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MAP from baseline
Measured: Periprocedural
Time required to achieve peak MAP response
Measured: Periprocedural
Secondary outcomes (4)
Change in heart rate per minute
Measured: Periprocedural
Duration of MAP elevation
Measured: Periprocedural
Stimulation tolerability (measured via NRS/VRS)
Patients will relate tolerability via NRS scale 0-10 and via verbal description
Measured: Periprocedural
Device related adverse events
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Markey Olson
- Sponsor type
- University, hospital or other
- Collaborators
- Cervical Spine Research Society
- Responsible party
- Sponsor-investigator, Markey Olson, St. Joseph's Hospital and Medical Center, Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887373
- Sponsor's protocol ID
- 27-500-066-70-06
- Acronym
- Stim for MAP
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation in the Hyperacute Setting of Spinal Cord Injury, a Feasibility Trial
- ClinicalTrials.gov ID
- NCT07887373
- Acronym / sponsor ID
- Stim for MAP / 27-500-066-70-06
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Markey OlsonUniversity, hospital or other
- Collaborators
- Cervical Spine Research Society
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Device: Spinal Cord StimulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Spinal Cord StimulationParticipants 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 |
Primary outcome
Change in MAP from baseline
Time frame: Periprocedural
Time required to achieve peak MAP response
Time frame: Periprocedural
4 secondary outcomes
Change in heart rate per minute
Time frame: Periprocedural
Duration of MAP elevation
Time frame: Periprocedural
Stimulation tolerability (measured via NRS/VRS)
Time frame: Periprocedural
Device related adverse events
Time frame: Periprocedural
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 21 Oct 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation in people with Spinal Cord Injury Cervical and Spinal Cord Injuries (SCI), run by Markey Olson.
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 6 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Markey Olson, PhD (602-406-5944, neuromodulationresearch@commonspirit.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MAP from baseline (time frame: Periprocedural). The study lists 2 primary outcomes in all. 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 21 Oct 2026.