Spinal Stimulation for Healthy Subjects
(STEPSS Trial)
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.12345Why 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.26789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gail Forrest
Lead Sponsor
Citations
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) ...
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, ...
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 ...
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/s12984-025-01557-4Non-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 ...
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 ...
Spinal Cord Stimulation - Indications, Safety, and Warnings
Indications, safety, and warnings for Medtronic spinal cord stimulation products.
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 ...
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.
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