Healthy AdultsNCT06116838
Transcutaneous Spinal Cord Stimulation in Healthy Adults
A study testing Spinal motor evoked responses (sMERs) and Continuous stimulation tolerance in people with Healthy Adults, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The goal of this study is to understand how transcutaneous spinal cord stimulation (tSCS) waveform, modulation frequency, and stimulation location impact lower extremity muscle activation and participant comfort in adults without neurologic conditions. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Spinal motor evoked responses (sMERs) and Continuous stimulation tolerance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 31 Dec 2028
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years old
- Able and willing to give written consent and comply with study procedures
Who cannot join
- History of stroke or neurologic pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- Pregnant or nursing
- Skin allergies or irritation; open wounds
- Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
- History of seizures or epilepsy
- Active cancer or cancer in remission less than 5 years
Show all 9Show fewer
- Metal implants in the back or spine
- Painful musculoskeletal dysfunction due to injury or infection
- Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Varying Transcutaneous Spinal Cord Stimulation Parameters and Location on Lower Extremity Motor Responses and Comfort
The goal of this study is to understand how transcutaneous spinal cord stimulation (tSCS) waveform, modulation frequency, and stimulation location impact lower extremity muscle activation and participant comfort in adults without neurologic conditions.
Read the detailed description
Investigators will use a test-retest design comparing neurophysiologic measures while receiving various combinations of stimulation waveforms, modulation frequencies, and stimulation locations to determine the settings which lead to the highest participant tolerance with the lowest lower extremity resting motor thresholds (RMTs).
- Conditions
- Healthy Adults
- Being tested
- Spinal motor evoked responses (sMERs), Continuous stimulation tolerance
- Keywords
- Transcutaneous spinal cord stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal motor evoked responses (sMERs)Device
Spinally Evoked Motor Responses (sMERs) will be obtained while stimulating with single pulses using various stimulation parameters. sMERs are the electromyograph (EMG) responses of the peripheral muscles to electrical stimulation of the spinal cord. sEMP will be used to test the integrity of the motor pathways of the spinal cord. This will be measuring by assessing the EMG responses in the lower limb muscles.
Continuous stimulation toleranceDevice
Participants may receive up to 45 min of locomotion training (treadmill or overground training) with transcutaneous spinal cord stimulation. The goal will be for the investigators to determine what amount of intensity at each stimulation site the individual finds to be comfortable enough that they would be able to receive without pain or discomfort
| Study group | Role | What they receive |
|---|---|---|
| Carrier frequency + Waveform | Experimental | Spinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at a single site with single pulses. sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. We will test various waveform combinations of biphasic and monophasic waveforms with modulation frequencies of 0-10 kHz. Participants will also ambulate while receiving continuous stimulation of the various waveform combinations to determine what stimulation intensity is comfortable for each combination. The order we complete this testing will be randomized. All participants will perform testing in a different order. Receives: Device: Spinal motor evoked responses (sMERs); Device: Continuous stimulation tolerance |
| Stimulation Location | Experimental | Spinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at various stimulation locations with single pulses. sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. Participants will also ambulate while receiving continuous stimulation to various stimulation locations to determine what stimulation intensity is comfortable for each location. The order we complete this testing will be randomized. All participants will perform testing in a different order. Receives: Device: Spinal motor evoked responses (sMERs); Device: Continuous stimulation tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting motor threshold
The RMT is the minimum intensity of stimulation required to evoke a motor response in the lower-limb muscles while the subject is at rest.
Measured: All study visits (1-10), over the course of up to 5 weeks
Continuous stimulation tolerance
Participants may receive up to 45 min of locomotion training (treadmill or overground training) with transcutaneous spinal cord stimulation. Participants will report what level of stimulation intensity they consider comfortable or tolerable (rating of less than 8 out of 10 on the Rating of Perceived Discomfort scale)
Measured: All study visits (1-10), over the course of up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start20 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- The purpose of these visits is to determine the optimal waveform and stimulation location. In order to make this determination, we will first determine what stimulation waveform allows us to reach Resting Motor Threshold (RMT) with the lowest intensity but it is the most comfortable when walking at higher intensities. We will use a test-retest design comparing neurophysiologic measures while participants receive various combinations of stimulation waveforms, modulation frequencies, and stimulation locations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayarman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116838
- Sponsor's protocol ID
- STU00219704
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varying Transcutaneous Spinal Cord Stimulation Parameters and Location on Lower Extremity Motor Responses and Comfort
- ClinicalTrials.gov ID
- NCT06116838
- Acronym / sponsor ID
- STU00219704
- Conditions
- Healthy Adults
- Keywords
- Transcutaneous spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Nov 2023 (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 goal of this study is to understand how transcutaneous spinal cord stimulation (tSCS) waveform, modulation frequency, and stimulation location impact lower extremity muscle activation and participant comfort in adults without neurologic conditions.
Detailed description
Investigators will use a test-retest design comparing neurophysiologic measures while receiving various combinations of stimulation waveforms, modulation frequencies, and stimulation locations to determine the settings which lead to the highest participant tolerance with the lowest lower extremity resting motor thresholds (RMTs).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The purpose of these visits is to determine the optimal waveform and stimulation location. In order to make this determination, we will first determine what stimulation waveform allows us to reach Resting Motor Threshold (RMT) with the lowest intensity but it is the most comfortable when walking at higher intensities. We will use a test-retest design comparing neurophysiologic measures while participants receive various combinations of stimulation waveforms, modulation frequencies, and stimulation locations.
| Arm | Type | Receives |
|---|---|---|
| Carrier frequency + Waveform | Experimental | Device: Spinal motor evoked responses (sMERs), Device: Continuous stimulation toleranceSpinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at a single site with single pulses. sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. We will test various waveform combinations of biphasic and monophasic waveforms with modulation frequencies of 0-10 kHz. Participants will also ambulate while receiving continuous stimulation of the various waveform combinations to determine what stimulation intensity is comfortable for each combination. The order we complete this testing will be randomized. All participants will perform testing in a different order. |
| Stimulation Location | Experimental | Device: Spinal motor evoked responses (sMERs), Device: Continuous stimulation toleranceSpinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at various stimulation locations with single pulses. sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. Participants will also ambulate while receiving continuous stimulation to various stimulation locations to determine what stimulation intensity is comfortable for each location. The order we complete this testing will be randomized. All participants will perform testing in a different order. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75 years old
- Able and willing to give written consent and comply with study procedures
Key exclusion criteria (9 listed)
- History of stroke or neurologic pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
- Pregnant or nursing
- Skin allergies or irritation; open wounds
- Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
- History of seizures or epilepsy
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 motor evoked responses (sMERs)Spinally Evoked Motor Responses (sMERs) will be obtained while stimulating with single pulses using various stimulation parameters. sMERs are the electromyograph (EMG) responses of the peripheral muscles to electrical stimulation of the spinal cord. sEMP will be used to test the integrity of the motor pathways of the spinal cord. This will be measuring by assessing the EMG responses in the lower limb muscles. | Device | Carrier frequency + Waveform, Stimulation Location |
| Continuous stimulation toleranceParticipants may receive up to 45 min of locomotion training (treadmill or overground training) with transcutaneous spinal cord stimulation. The goal will be for the investigators to determine what amount of intensity at each stimulation site the individual finds to be comfortable enough that they would be able to receive without pain or discomfort | Device | Carrier frequency + Waveform, Stimulation Location |
Primary outcome
Resting motor threshold
Time frame: All study visits (1-10), over the course of up to 5 weeks
The RMT is the minimum intensity of stimulation required to evoke a motor response in the lower-limb muscles while the subject is at rest.
Continuous stimulation tolerance
Time frame: All study visits (1-10), over the course of up to 5 weeks
Participants may receive up to 45 min of locomotion training (treadmill or overground training) with transcutaneous spinal cord stimulation. Participants will report what level of stimulation intensity they consider comfortable or tolerable (rating of less than 8 out of 10 on the Rating of Perceived Discomfort scale)
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 27 Apr 2026.
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
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. This study is not recruiting at the moment.
Arun Jayarman, PT, PhD principal investigator
Shirley Ryan AbilityLab
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 motor evoked responses (sMERs) and Continuous stimulation tolerance in people with Healthy Adults, run by Shirley Ryan AbilityLab 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 2 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting motor threshold (time frame: All study visits (1-10), over the course of up to 5 weeks). The study lists 2 primary outcomes in all. 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 27 Apr 2026.