Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT07090473

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

Led by University of California, San Francisco · Updated on 2026-04-13

15

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

C

Congressionally Directed Medical Research Programs

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent is obtained
  • Acute traumatic cervicothoracic spinal cord injury presenting within 12 hours of injury
  • Traumatic non-penetrating spinal cord injury
  • American Impairment Scale (AIS) Grade A, B, or C
  • Neurological level of injury between C4 and T10 according to ISNCSCI
  • Age 18 years or older
  • Admission to Intensive Care Unit with lumbar drain in place per standard of care
Not Eligible

You will not qualify if you...

  • AIS Grade D or E
  • Penetrating spinal cord injuries or complete spinal cord transection
  • Pregnancy
  • Incarceration or police custody
  • Class 2 or Class 3 obesity
  • Any injury or condition that interferes with study procedures including:
    • 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 with Glasgow Coma Scale less than 14 at enrollment or inability to participate in exam

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Trial Site Locations

Total: 1 location

1

Zuckerberg San Francisco General Hospital

San Francisco, California, United States, 94110

Actively Recruiting

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Research Team

C

Clinical Research Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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