Comparing an updated non-invasive spinal stimulation device with the current device
Multi-Channel Spinal Transcutaneous Electrical Pulsed Stimulation System: STEPSS
NA · Kessler Foundation · NCT07217314
This study will test an updated non-invasive spinal stimulation device against the currently used device in healthy adults to see if the new device is better tolerated and overcomes limitations of the older model.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kessler Foundation (other) |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT07217314 on ClinicalTrials.gov |
What this trial studies
Researchers will apply non-invasive spinal stimulation to healthy adult volunteers using both the updated device and the currently used device to compare performance and tolerability. Participants who meet screening criteria will attend a testing session where device settings, participant comfort, and any immediate physiological responses will be recorded. The protocol focuses on safety, participant experience, and technical performance rather than therapeutic effect. Data will inform whether the updated device addresses specific limitations of the existing device and is suitable for future use in spinal cord injury research.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who are English proficient, can give informed consent, are available for the testing session, and have no neurological, uncontrolled cardiovascular/pulmonary, skin, or medication-related issues that would interfere with spinal stimulation.
Not a fit: People with past or present nervous system injury or disease, untreated autonomic instability, heart or lung disease, pregnancy, skin conditions affecting stimulation, interfering medications, or ongoing drug abuse are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, the updated device could offer improved comfort, safety, and technical performance for future spinal stimulation use in research and therapy.
How similar studies have performed: Non-invasive spinal stimulation approaches have shown promise in research settings for spinal cord injury, but device upgrades are typically incremental and this specific updated device has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age * Proficient in English * Available for the testing session * Able to give informed consent * Able to tolerate spinal stimulation Exclusion Criteria: * Pregnant (female only). * Untreated severe and persistent problems regulating blood pressure, heart rate, or other automatic functions. * Any past or present injury or disease to the nervous system * Heart or lung disease that may interfere with stimulation * A skin condition in any area that may affect the ability to receive stimulation * Taking any medication that may affect the ability to receive spinal stimulation * Ongoing drug abuse
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (RECRUITING)
Study contacts
- Study coordinator: Research Manager
- Email: LMartinez@KesslerFoundation.Org
- Phone: 9733243557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Participants