Transcutaneous Spinal Cord Stimulation in Healthy Adults
NCT ID: NCT06116838
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
SINGLE
Study Groups
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Carrier frequency + Waveform
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.
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.
Continuous 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
Stimulation Location
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.
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.
Continuous 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
Interventions
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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.
Continuous 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
Eligibility Criteria
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Inclusion Criteria
* Able and willing to give written consent and comply with study procedures
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
Yes
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Executive Director, Technology & Innovation Hub (tiHUB); Director, Max Näder Center for Rehabilitation Technologies & Outcomes Research
Principal Investigators
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Arun Jayarman, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00219704
Identifier Type: -
Identifier Source: org_study_id
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