NCT07090473 · University of California, San Francisco
Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes
(STEP-RAISE)
What this study is about
The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement.
View original scientific description
The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement. The main questions it aims to answer are: * is starting electrical stimulation 3 days post SCI safe? * can starting electrical stimulation 3 days post SCI help patients recover movement? This study will be done in two phases. Both phases will be done during the patient's stay in the hospital/intensive care unit (ICU). In the first phase, participants' will undergo several tests before and after a single treatment. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs and feel touch or pin prick * blood and cerebral spinal fluid draws * assessment of their spinal cord function using electrical stimulation * receive a single 60-minute continuous electrical stimulation treatment * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings. In the second phase, researchers will compare active electrical stimulation to sham stimulation to see if active stimulation safely leads to improvement in person's movement ability. In this second phase, participants' will undergo tests before and after electrical stimulation treatment which will be delivered 5 days in the row. Assessments will be repeated before the patient will go home at around 7 days post injury. * assessment of the ability to move arms/legs (every day) and feel touch or pin prick (before and after 5 days of treatment) * blood and cerebral spinal fluid draws (before the first treatment session and before going home) * assessment of their spinal cord function using electrical stimulation (before the first treatment session and before going home) * receive daily 60-minute continuous electrical stimulation treatment for 5 days while in ICU * patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.
Interventions
DEVICE
transcutaneous spinal cord stimulation
Transcutaneous spinal stimulation will be delivered using the experimental ARC-EX device (ONWARD Medical), via skin surface electrodes placed over the spine (stimulating electrodes) and bilaterally on the iliac crests (reference electrodes) during the intervention.
DEVICE
sham transcutaneous spinal cord stimulation
For sham transcutaneous spinal stimulation electrodes will be placed on the skin surface over the spine and bilaterally on the iliac crests and will be attached to the experimental ARCEX device (ONWARD Medical), however no electrical current will be delivered.
Primary outcome measures
Incidence of adverse events
Time frame: From enrollment to the end of treatment at 7 days post injury
Number of observed events over the transcutaneous spinal cord stimulation (tSCS) sessions. Examples of adverse events (AE) that will be carefully monitored * Hemodynamic instability * Skin irritation * Patient condition deterioration * Unanticipated AE
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores
Time frame: From enrollment to the end of study at 6 months follow up
International Standards for Neurological Classification of SCI (ISNCSCI) motor scores; Standardized manual muscle testing is used to assess the strength of each key muscle, typically on a 6-point scale (0-5, 0 - total paralysis to 5 - normal strength with full ROM against gravity and maximal resistance); The motor score is derived by summing the individual muscle grades, with a maximum score of 50 for each upper and lower extremity, and a total maximum score of 100 for both limbs. Immediate change in scores with acute tSCS and change in scores from baseline to post treatment and at 6-month follow up will be assessed in the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A subject will be eligible for enrollment in the study of the following criteria apply:
- Written informed consent is obtained.
- Acute traumatic cervicothoracic SCI that meets all of the following criteria:
- Acute SCI presenting to the hospital within 12 hours of injury
- Traumatic non-penetrating SCI
- American Impairment Scale (AIS) Grade A, B, or C
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10
- Aged \>/=18 years
- 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:
- Subjects classified as AIS D or E
- Penetrating SCIs or complete transection of the spinal cord
- Incarceration or police custody
- Class 2 or Class 3 obesity
- 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:
- multiple spinal cord lesions
- fractures requiring lower extremity casts or splints
- skin breakdown or burns over the lumbar spine
- profound hemodynamic instability
- traumatic brain injury (defined by Glasgow Coma Scale (GCS) \<14 at enrollment or inability to participate in exam)
Where
- San Francisco, California
Collaborators
Congressionally Directed Medical Research Programs
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations