Transcutaneous Spinal Cord Stimulation in Healthy Adults

Not Applicable

Not yet recruiting

• Conditions: Healthy Adults

• Registration Number: NCT06116838
• Lead Sponsor: Shirley Ryan AbilityLab

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).

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Start: 2025-10
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Continuous stimulation tolerance	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)
Resting motor threshold	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.

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States