Recruiting

Electrical Stimulation

Sponsor:

UCLA

Code:

NCT07090473

Conditions

Acute Spinal Cord Injury (SCI)

Acute Spinal Cord Injury of Traumatic Origin (tSCI)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

transcutaneous spinal cord stimulation

sham transcutaneous spinal cord stimulation

Study Details

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)

Study ID

NCT07090473

Start date

Apr 10, 2026

Status verified date

Jun, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active tSCS

active treatment

sham comparator: sham tSCS

sham treatment

Interventions

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.

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.

Primary outcome measure

  • Incidence of adverse events [ Time Frame: From enrollment to the end of treatment at 7 days post injury ]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores [ Time Frame: From enrollment to the end of study at 6 months follow up ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

628-206- 3859tracksci@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Clinical Research Coordinator

628-206-3859tracksci@ucsf.edu

Principal Investigator:

Rajiv Saigal, MD, PhD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-04.