NCT07090473 Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes
| NCT ID | NCT07090473 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Acute Spinal Cord Injury (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2026-04-10 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Rajiv Saigal, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07090473 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Acute Spinal Cord Injury (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07090473 currently recruiting?
Yes, NCT07090473 is actively recruiting participants. Contact the research team at tracksci@ucsf.edu for enrollment information.
Where is the NCT07090473 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07090473 clinical trial?
NCT07090473 is sponsored by University of California, San Francisco. The principal investigator is Rajiv Saigal, MD, PhD at University of California, San Francisco. The trial plans to enroll 15 participants.