Transcutaneous Spinal Cord Stimulation in Healthy Adults

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116838
• Other study ID #: STU00219704
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Shirley Ryan AbilityLab
• Contact: Kelly McKenzie, PT, DPT
• Phone: 2175210169
• Email: kmckenzie[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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