Healthy ParticipantsSTEPSS/ARC-exNCT07217314
Testing Non-Invasive Spinal Stimulation Devices
A study testing Spinal Stimulation in people with Healthy Participants, run by Gail Forrest at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Spinal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Proficient in English
- Available for the testing session
- Able to give informed consent
- Able to tolerate spinal stimulation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Research Manager, 9733243557, LMartinez@KesslerFoundation.Org
Gail F Forrest, PhD
About this study
Official title: Multi-Channel Spinal Transcutaneous Electrical Pulsed Stimulation System: STEPSS
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.
- Conditions
- Healthy Participants
- Being tested
- Spinal Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | Not described Receives: Device: Spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg EMG activity during spinal stimulation
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.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start29 May 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gail Forrest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gail Forrest, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217314
- Sponsor's protocol ID
- R-1283-24
- Acronym
- STEPSS/ARC-ex
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Channel Spinal Transcutaneous Electrical Pulsed Stimulation System: STEPSS
- ClinicalTrials.gov ID
- NCT07217314
- Acronym / sponsor ID
- STEPSS/ARC-ex / R-1283-24
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Gail ForrestUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Device: Spinal Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Proficient in English
- Available for the testing session
- Able to give informed consent
- Able to tolerate spinal stimulation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal StimulationParticipants 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. | Device | Healthy Participants |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Stimulation in people with Healthy Participants, run by Gail Forrest at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Manager (9733243557, LMartinez@KesslerFoundation.Org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg EMG activity during spinal stimulation (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.