Transcutaneous Spinal Cord Stimulation in Healthy Adults

NCT06116838 | Active Not Recruiting FDA Device

• 1 other identifier: STU00219704
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Keywords

Transcutaneous spinal cord stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  All study visits (1-10), over the course of up to 5 weeks

Study Arms (2)

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.

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.

Device: Spinal motor evoked responses (sMERs); Device: Continuous stimulation tolerance

Interventions

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.

Carrier frequency + Waveform; Stimulation Location

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

Carrier frequency + Waveform; Stimulation Location

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Study Officials

• Arun Jayarman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Technology & Innovation Hub (tiHUB); Director, Max Näder Center for Rehabilitation Technologies & Outcomes Research

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 3, 2023
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)