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Transcutaneous Spinal Cord Stimulation in Healthy Adults

Effect of Varying Transcutaneous Spinal Cord Stimulation Parameters and Location on Lower Extremity Motor Responses and Comfort

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116838
Enrollment
50
Registered
2023-11-03
Start date
2025-10-20
Completion date
2028-12-31
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Keywords

Transcutaneous spinal cord stimulation

Brief 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.

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).

Interventions

DEVICESpinal 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.

DEVICEContinuous stimulation tolerance

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

Sponsors

Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-75 years old * Able and willing to give written consent and comply with study procedures

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Resting motor thresholdAll study visits (1-10), over the course of up to 5 weeksThe 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 toleranceAll study visits (1-10), over the course of up to 5 weeksParticipants 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)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORArun Jayarman, PT, PhD

Shirley Ryan AbilityLab

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026