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Spinal stimulation 3 days after injury: safe or not?

NCT ID NCT07090473

Symptom relief Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether applying mild electrical stimulation to the skin over the spine, starting just 3 days after a traumatic spinal cord injury, is safe and might help patients recover movement. Fifteen adults with acute spinal cord injury will receive either real or sham stimulation while in the ICU. Researchers will monitor side effects and measure changes in muscle strength and sensation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous spinal cord stimulation (ARC-EX device)
What this could lead to
If safe and effective, this could point toward a non-invasive way to help people regain movement after spinal cord injury.
What could go wrong
This is a very small, early safety study with only 15 participants. It is not designed to prove the treatment works, and results may not apply to all spinal cord injuries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A subject will be eligible for enrollment in the study of the following criteria apply: 1. Written informed consent is obtained. 2. Acute traumatic cervicothoracic SCI that meets all of the following criteria: 1. Acute SCI presenting to the hospital within 12 hours of injury 2. Traumatic non-penetrating SCI 3. American Impairment Scale (AIS) Grade A, B, or C 4. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10 3. Aged \>/=18 years 4. Admission to Intensive Care Unite (ICU) with lumbar drain in place per standard of care Exclusion Criteria: A subject will not be eligible for this study if ANY of the following criteria apply: 1. Subjects classified as AIS D or E 2. Penetrating SCIs or complete transection of the spinal cord 3. Pregnancy 4. Incarceration or police custody 5. Class 2 or Class 3 obesity 6. Any concomitant injury that, in the judgment of the Investigator, interferes with the procedures and examinations required by the study protocol, including but not limited to: 1. multiple spinal cord lesions 2. fractures requiring lower extremity casts or splints 3. skin breakdown or burns over the lumbar spine 4. profound hemodynamic instability 5. traumatic brain injury (defined by Glasgow Coma Scale (GCS) \<14 at enrollment or inability to participate in exam)

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute spinal cord injury (SCI) Acute spinal cord injury of traumatic origin (TSCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zuckerberg San Francisco General Hospital

    RECRUITING

    San Francisco, California, 94110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.