Testing a Non-Invasive Spinal Stimulation Device

NCT07217314 | Recruiting

• 1 other identifier: R-1283-24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare an updated spinal stimulation device 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. This device was updated to improve upon limitations in the currently used device.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Leg EMG activity during STEPPS spinal stimulations

  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. Four trials of stimulation with EMG recording will be given over the course of 2 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 STEPSS stimulators.

  up to 6 weeks

Study Arms (1)

Healthy Participants

EXPERIMENTAL

Device: Spinal Stimulation

Interventions

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 2 hours to complete on each day. The 2 hours includes set-up/placement of the electrodes, 4 trials of stimulation with breaks, and removal of electrodes after testing.

Healthy Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Proficient in English
• Available for the testing session
• Able to give informed consent
• Able to tolerate spinal stimulation

You may not qualify if:

• 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

Sponsors & Collaborators

• Gail Forrest: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Interventions

Spinal Cord Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Research Manager

CONTACT

9733243557; LMartinez@KesslerFoundation.Org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Tim and Caroline Reynolds Center for Spinal Stimulation

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 15, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 15, 2025

Record last verified: 2025-08

Locations

US (1)