Transcutaneous Spinal Cord Stimulation in Healthy Adults

Shirley Ryan AbilityLab

Status: Not yet enrolling

Conditions: Healthy Adults

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06116838

STU00219704

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Carrier frequency + Waveform

Experimental group

Description:

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.

Treatment:

Device: Spinal motor evoked responses (sMERs)

Device: Continuous stimulation tolerance

Stimulation Location

Experimental group

Description:

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.

Treatment:

Device: Spinal motor evoked responses (sMERs)

Device: Continuous stimulation tolerance