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

NCT07090473 | Recruiting FDA Device

• 3 other identifiers: 23-40183CDMRP-SC240091CDMRP-SC240091P1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Spinal Cord Injury (SCI); Acute Spinal Cord Injury of Traumatic Origin (tSCI)

Keywords

acute spinal cord injury; transcutaneous spinal cord stimulation; acute rehabilitation; acute traumatic spinal cord injury

Outcome Measures

Primary Outcomes (2)

• 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

  From enrollment to the end of treatment at 7 days post injury

• 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.

  From enrollment to the end of study at 6 months follow up

Secondary Outcomes (9)

• Concentration of neuronal (UCH-L1) and glial cell (GFAP) injury markers in blood

  From enrollment to the end of treatment at 7 days post SCI

• Cerebrospinal fluid (CSF) proteomics

  From enrollment to the end of treatment at 7 days post SCI

• Incidence of neuropathic pain at 6-month follow-up

  From enrollment to study completion at 6-months follow up

• Electromyography (EMG)

  From enrollment to study completion at 6 months follow up

• Motor evoked potentials (MEPs)

  From enrollment to post treatment at 7 days post injury

Study Arms (2)

active_tSCS

EXPERIMENTAL

active treatment

Device: transcutaneous spinal cord stimulation

sham_tSCS

SHAM COMPARATOR

sham treatment

Device: sham transcutaneous spinal cord stimulation

Interventions

transcutaneous spinal cord stimulation DEVICE

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.

Also known as: non-invasive spinal cord stimulation

active_tSCS

sham transcutaneous spinal cord stimulation DEVICE

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.

sham_tSCS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy
• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Study Officials

• Rajiv Saigal, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Anastasia V Keller, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

628-206- 3859; tracksci@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 29, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)