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.
Written informed consent is obtained.
Acute SCI presenting to the hospital within 12 hours of injury
Traumatic non-penetrating SCI
American Impairment Scale (AIS) Grade A, B, or C
Subjects classified as AIS D or E
Penetrating SCIs or complete transection of the spinal cord
Pregnancy
Incarceration or police custody
Parallel
transcutaneous spinal cord stimulation
DeviceTranscutaneous 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.
sham transcutaneous spinal cord stimulation
DeviceFor 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.
Incidence of adverse events
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
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.
Concentration of neuronal (UCH-L1) and glial cell (GFAP) injury markers in blood
Blood draw will be collected at baseline post treatment or prior to discharge. Changes in ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) levels from baseline to post treatment will be assayed on the Abbott Alinity I Immunoassay system. Additionally, plasma will be analyzed using commercially available high-throughput protein biomarker discovery platform based on Olink's Proximity Extension Assay (PEA), which reliably measures \>3,000 proteins using \<1mL of biofluid
Cerebrospinal fluid (CSF) proteomics
CSF will be collected from the lumbar drain tube that is typically placed for acute spinal cord injury management. Changes in protein levels in CSF from baseline to post treatment will be analyzed using commercially available high-throughput protein biomarker discovery platform based on Olink's Proximity Extension Assay (PEA), which reliably measures \>3,000 proteins using \<1mL of biofluid.
Incidence of neuropathic pain at 6-month follow-up
DN4 (Neuropathic Pain 4) questionnaire will be used to assess incidence of neuropathic pain at 6-months follow- up in tSCS vs. sham individuals. The DN4 is scored by assigning a value of 1 for each "yes" response and 0 for each "no" response to the 10 questions. A total score is then calculated by summing the scores for all 10 items. A score of 4 or more suggests the presence of neuropathic pain.
Electromyography (EMG)
Eight surface electromyography recording electrodes, placed bilaterally over the lower extremity muscles: Rectus Femoris (RF), Biceps Femoris (BF), Medial Gastrocnemius (MG) and Tibialis Anterior (TA) will be used to record motor output (EMG activity) during ISNCSCI assessment. Changes in EMG amplitude in the presence of tSCS vs no tSCS (within subject); changes in the number of muscles with EMG output in the presence of tSCS vs no tSCS (within subject) will be analyzed.
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University of California, San Francisco
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
