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OpenTrials
Active, Not Recruiting

NCT Number: NCT06116838

Transcutaneous Spinal Cord Stimulation in Healthy Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Adults

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 tolerance

Device

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

Primary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 3, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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