Transcutaneous Electrical Stimulation for Spinal Cord Injury

(STEP-RAISE Trial)

Overseen By Xuan Duong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnancy, Obesity, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of using electrical stimulation on the skin to help people regain movement after a spinal cord injury (SCI). Participants will receive either active or sham (placebo) electrical stimulation starting three days after their injury to assess improvements in movement ability. The trial seeks patients who have recently experienced a spinal cord injury affecting their neck or upper back and were admitted to the hospital within 12 hours of the injury.

As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance recovery options for spinal cord injuries.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcutaneous electrical stimulation is safe for spinal cord injury patients?

Research has shown that transcutaneous electrical spinal cord stimulation (tSCS) is generally safe for people with spinal cord injuries. One study found that using tSCS alongside rehabilitation activities has a good safety record and does not cause major side effects, particularly concerning heart and blood pressure. Another study confirmed that tSCS is safe for use both in clinics and at home, and it can help improve strength in people with long-term spinal cord injuries.

These findings suggest that tSCS is well-tolerated and does not lead to serious side effects. The electrical stimulation, applied to the skin and carefully monitored, ensures safety during treatment. While individual experiences may differ, current evidence supports the safe use of this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for spinal cord injury, which often involve medication and physical therapy, transcutaneous electrical stimulation (tSCS) offers a non-invasive approach by delivering electrical currents through the skin to stimulate nerve activity below the injury site. Researchers are excited about tSCS because it has the potential to enhance motor function and sensory recovery without the need for surgery or pharmaceuticals. This technique is particularly promising as it may offer quicker improvements in mobility and independence for patients with spinal cord injuries.

What evidence suggests that transcutaneous electrical stimulation is effective for spinal cord injury?

Research has shown that transcutaneous electrical stimulation (tSCS) may aid recovery from spinal cord injuries. In this trial, participants will receive either active tSCS or a sham treatment. Studies have found that tSCS can enhance balance, stability, and lower body movement, even in long-term cases. Patients who received tSCS alongside other treatments experienced better recovery after many sessions. Some benefits also included reduced pain following spinal cord injuries. Overall, early evidence suggests that tSCS might improve movement and recovery for those with spinal cord injuries. ^{5 6 7 8 9}

Who Is on the Research Team?

Anastasia V Keller, PhD

Principal Investigator

University of California, San Francisco

Rajiv Saigal, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with recent spinal cord injuries. It's testing if starting electrical stimulation through the skin 3 days after injury is safe and helps in movement recovery. Participants will be in hospital/ICU, undergo tests, and receive either real or sham stimulation.

Inclusion Criteria

1. Written informed consent is obtained.

1. Acute SCI presenting to the hospital within 12 hours of injury

2. Traumatic non-penetrating SCI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 days

Phase 1 Treatment

Participants undergo several tests before and after a single 60-minute electrical stimulation treatment. Assessments include movement ability, blood and CSF draws, and spinal cord function using electrical stimulation.

7 days

Daily assessments during hospital stay

Phase 2 Treatment

Comparison of active electrical stimulation to sham stimulation over 5 consecutive days. Daily assessments of movement ability, blood and CSF draws, and spinal cord function.

5 days

Daily assessments during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neurological function and biomarker analysis.

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Stimulation

Trial Overview The study examines transcutaneous spinal cord stimulation versus a sham (fake) treatment to see if it can safely improve patients' ability to move post-injury. The intervention starts 3 days after injury and includes daily sessions over five days with monitoring.

How Is the Trial Designed?

Group I: active_tSCS Experimental Treatment 1 Intervention

active treatment

Group II: sham_tSCS Placebo Group 1 Intervention

sham treatment

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Effectiveness of Transcutaneous Spinal Cord Stimulation for ... This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, or other ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

3. nature.com nature.com/articles/s41393-022-00776-z

Efficacy of transcutaneous electrical nerve stimulation in ... Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury.

4. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... Enhanced trunk control and stability (9), improved lower extremity (LE) function, locomotor output, and standing (6, 8, 13) as well as reduced ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07090473

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ... Transcutaneous spinal cord stimulation has shown great promise in chronic spinal cord injury rehabilitation medicine through maximizing residual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9396932/

Transcutaneous Electrical Spinal Cord Stimulation to ... Objective: To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN240014.pdf

Transcutaneous electrical spine stimulator to improve skeletal ... The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic ...

9. neurology.org neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Clinic and home-based ARCEX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.