Spinal Stimulation for Healthy Subjects

(STEPSS Trial)

Overseen By Research Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gail Forrest

Must not be taking: Spinal stimulants

Disqualifiers: Pregnancy, Heart disease, Drug abuse, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new version of a spinal stimulation device, comparing it to the current model. Spinal stimulation often aids individuals with spinal cord injuries. The updated device aims to address some limitations of the existing one. Healthy individuals who can tolerate spinal stimulation and have no history of nervous system issues or untreated heart or lung diseases may qualify for this study.

As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative spinal treatment technology.

Will I have to stop taking my current medications?

The trial excludes people taking medications that might affect spinal stimulation, so you may need to stop certain medications. It's best to discuss your specific medications with the trial team to see if they are allowed.

What prior data suggests that this spinal stimulation device is safe for healthy subjects?

Research has shown that spinal stimulation devices are generally safe for use. These devices have been studied for aiding those with spinal cord injuries and have a history of safety. For instance, the Eterna Spinal Cord Stimulation System has received approval in the U.S. for treating chronic pain, indicating its safety.

Studies on similar devices have found that most people do not experience serious side effects. The most common issues are minor, such as skin irritation at the device site. One study found that non-invasive spinal stimulation can safely and effectively improve hand and arm functions in people with spinal cord injuries.

Overall, while no treatment is completely without risk, spinal stimulation devices have demonstrated a strong safety record in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves medications or invasive procedures for spinal issues, the non-invasive spinal stimulation device offers a unique, pain-free alternative. This device is designed to stimulate the spine without surgery, making it a potentially safer and less daunting option for patients. Researchers are particularly excited about its ability to target spinal function directly, which could lead to improved mobility and quality of life without the risks associated with more invasive treatments.

What evidence suggests that this spinal stimulation device is effective for healthy subjects?

Research has shown that non-invasive spinal stimulation can be effective. In one study, 72% of participants experienced significant improvement with this treatment. This method uses electrical signals to enhance movement and strength, particularly for individuals with spinal cord injuries. The device operates without surgery, reducing risk. Overall, evidence suggests it could be a promising option for enhancing muscle control and recovery. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This clinical trial is open to healthy individuals. Specific eligibility criteria are not detailed, but typically participants should have no underlying health conditions that could interfere with the study.

Inclusion Criteria

Proficient in English

Available for the testing session

Able to give informed consent

Exclusion Criteria

Ongoing drug abuse

I am not pregnant.

I have heart or lung conditions that could affect medical treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will receive spinal stimulation using the STEPSS device, with electrodes placed over spinal site locations and right leg muscles to measure EMG activity.

6 weeks

3 visits (in-person), each lasting 2 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-Invasive Spinal Stimulation Device

Trial Overview The study is testing a new non-invasive spinal stimulation device and comparing it to an existing one. The goal is to see if the updated device offers improvements over the current model used in spinal cord injury research.

How Is the Trial Designed?

Group I: Healthy Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Gail Forrest

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11108781/

Non-invasive spinal cord electrical stimulation for arm and ... Of the 60 participants included in the primary effectiveness endpoint analysis, 43 (72%) met or exceeded the minimally important difference (MID) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023004704

Real World Characterization of Chronic Pain, Success ... We present real-world data from 7,000 patients who underwent SCSeval while utilizing a mobile digital health platform for education, feedback, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07217314

Testing a Non-Invasive Spinal Stimulation Device An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ... This systematic review and network meta-analysis evaluates the efficacy associated with conventional and novel spinal cord stimulation ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01557-4

Non-invasive cerebral and spinal cord stimulation for motor ... In this review we aim to compare the effect of non-invasive cerebral and spinal cord stimulation on gait recovery and motor strength of lower limbs in subjects ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032S191B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Eterna Spinal Cord Stimulation System for the treatment of chronic pain of trunk and limbs is currently approved for commercial distribution in USA. The ...

7. medtronic.com medtronic.com/en-us/l/isw/spinal-cord-stimulation-indications-safety-warnings.html

Spinal Cord Stimulation - Indications, Safety, and Warnings Indications, safety, and warnings for Medtronic spinal cord stimulation products.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329040/

Spinal Cord Stimulators: An Analysis of the Adverse Events ... Previous spinal cord stimulator safety data have relied on short-term clinical trials. Given that the devices are marketed as long-term solutions to intractable ...

9. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.