Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether gentle electrical stimulation applied through the skin, starting about three days after a sudden spinal cord injury, is safe and can help improve movement in patients. The study will take place while patients are still in the hospital, including the intensive care unit (ICU). It has two parts: first, participants will receive a single 60-minute session of electrical stimulation and have their movement, sensation, and spinal cord function tested before and after. In the second part, some participants will receive daily electrical stimulation for five days, while others will get a placebo treatment, to see if real stimulation helps improve movement more safely over time.

People who may join this study are adults (18 years or older) who have recently (within 12 hours) experienced a traumatic spinal cord injury in the neck or upper back area and are admitted to the ICU with specific medical requirements. Those with certain types of injuries, other serious health issues, or pregnancy would not be eligible. Participants can expect regular assessments of their ability to move and feel sensations, blood and spinal fluid tests, and close safety monitoring throughout their hospital stay. This study aims to find safer ways to support recovery after spinal cord injury and help doctors better understand how electrical stimulation might aid healing.

Gender

ALL

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)