NCT07217314 · Gail Forrest
Testing Non-Invasive Spinal Stimulation Devices
(STEPSS/ARC-ex)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Spinal Stimulation
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 outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- West Orange, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations