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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Subjects classified as AIS D or E

Penetrating SCIs or complete transection of the spinal cord

Pregnancy

Incarceration or police custody

Trial design

Treatments tested in this trial

  • transcutaneous spinal cord stimulation
  • sham transcutaneous spinal cord stimulation

Treatment groups

15 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator