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NCT Number: NCT07217314

Testing Non-Invasive Spinal Stimulation Devices

The purpose of this study is to compare updated spinal stimulation devices with the spinal stimulation device that is currently used. Spinal stimulation is often used in studies aimed at assisting individuals with a spinal cord injury. These devices were updated to improve upon limitations in the currently used device. The devices will be compared in a group of people without spinal cord injury or other nervous system conditions.

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Key information

Conditions

Healthy Participants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location status: Recruiting

Location contact

Gail F Forrest, PhD

PRINCIPAL_INVESTIGATOR

Research Manager

CONTACT

[email protected]

9733243557

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Stimulation

Device

Participants will lay on their back and have small electrodes placed on the center of their backs and several leg muscles. The back electrodes, connected to a battery-operated unit, will send an electrical current to the spine. The leg electrodes will record muscle activity. This will take approximately 4 hours to complete on each day. The 4 hours includes set-up/placement of the electrodes for each device, 4 trials of stimulation for each device with breaks, and removal of electrodes after testing on each device.

Primary outcomes

  1. Leg EMG activity during spinal stimulation

    Time frame: up to 6 weeks

    Participants will have electrodes connected to the STEPPS stimulator, placed over spinal site locations (T10/11 & T11/12). These electrodes will send an electrical current to their spine while laying on their back. Additional electrodes will be placed over right leg muscles to measure leg EMG muscle activation during the spinal stimulation. The same procedures will be used for the ARC-ex stimulator.

    Four trials of each stimulation device with EMG recording will be given over the course of 4 hours each visit for 3 visits.

    Mean/standard deviation curves and correlation coefficients for right leg muscle activation will be calculated to compare curves for NRT (pre-existing data) and each stimulator.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Manager

CONTACT

[email protected]

9733243557

Sponsors and collaborators

Lead sponsor

Gail Forrest

Other

Registry information

Official study title

Multi-Channel Spinal Transcutaneous Electrical Pulsed Stimulation System: STEPSS

Acronym: STEPSS/ARC-ex

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 15, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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