Study Summary
Safety of Transcutaneous Electrical stimulation Potentiating Recovery in Acute spinal cord Injury SyndromEs (STEP-RAISE) is a combined Phase 1 and Phase 2 pilot clinical trial of non-invasive transcutaneous spinal cord stimulation (tSCS), aiming to track the course of neurophysiological recovery following acute spinal cord injury (SCI) with granular objective outcome measures to determine whether implementation of early tSCS below the level of lesion can safely augment the functional recovery.
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.
Study Site Locations
- University of California, San Francisco: Zuckerberg San Francisco General Hospital (San Francisco, California, United States of America)
What is involved?
- ​Access to the patient's hospitalization records for the SCI visit.
- Two blood draws of about 5 mL (1 tsp) each, at 3 and 7 days post-injury.
- Two cerebrospinal fluid draws of about 15 mL (3 tsp) each, at 3 and 7 days post-injury.
- Motor evoked potentials (MEP), a neurophysiological assessment which measures the response of muscles to spinal cord stimulation.
- Continuous transcutaneous spinal cord stimulation therapy (tSCS): stimulating electrodes are placed on the skin over the lower spine and two non-stimulating/reference electrodes are placed over each of the hip bones. Stimulation intensity is gradually increased/adjusted and is kept on for about 60 minutes.
- International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor and sensory assessments conducted at days 3-7, and 6 months post-injury.
- Questionnaires on health and well-being conducted on hospital admission and at 6 months post-injury.
- Pain assessment questionnaires (Neuropathic Pain Scale, NPS) conducted at 3 days, 7 days, and 6 months post-injury.
Who can participate?
Patients who meet the following inclusion criteria are eligible for admission into the study, providing they do not meet exclusion criteria.
- ZSFG hospital admission less than 12 hours from time of injury
- Age 18+
- Ability to give written informed consent
- Traumatic non-penetrating SCI
- ASIA Impairment Scale grade A, B, or C
- ISNCSCI neurological level of injury between C4 and T10
- Admission to ICU with lumbar drain in place per standard of care