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

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)

Interventions

DEVICE

transcutaneous spinal cord stimulation

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.

DEVICE

sham transcutaneous spinal cord stimulation

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.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs

  collaborator FED

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Rajiv Saigal, MD, PhD · University of California, San Francisco

• Anastasia V Keller, PhD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Device

Yes

Countries

• United States

Study Locations