Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation

NCT07206797 — Not applicable, Recruiting, 30 participants, North Carolina State University

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Registry	NCT07206797
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	30 (Estimated)
Sponsor	North Carolina State University (Other); collaborators: University of North Carolina, Chapel Hill
Conditions	Neuromodulatory Effects of TSCS and FES in Lower Limbs
Interventions	Functional Electrical Stimulation, Transcutaneous (Non-Invasive) Spinal Cord Stimulation, Ultrasound (Device)
Dates	start 2025-06-01, primary completion 2026-06-01 (estimated), completion 2026-06-01 (estimated), first posted 2025-10-03, last updated 2025-10-14
Locations	1 site in United States

-Summary

Transcutaneous (non-invasive) spinal cord stimulation (tSCS) has been shown to facilitate volitional motor activity in patients with spinal cord injury. tSCS is known to activate the same neural structures as invasive SCS, meaning it may have the potential for functional restoration without an expensive surgical implant. Functional electrical stimulation (FES) is also used in therapy for patients with spinal cord injury to locally activate paralyzed or weakened muscles. There is evidence that combining FES and tSCS may elicit greater muscle activation than either modality alone.

The objective of this study is to quantify the torque at the ankle joint generated by tSCS, by FES, and by tSCS + FES. Additionally, ultrasound images will be collected during stimulation to provide a metric of muscle activity. The correlation between ultrasound and torque will be assessed to determine if ultrasound is a useful modality for quantifying tSCS-elicited muscle activity.

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+Arms and interventions

Arm	Type	Interventions	Description
Subjects without Disability	Experimental	Device: Functional Electrical Stimulation; Device: Transcutaneous (Non-Invasive) Spinal Cord Stimulation; Device: Ultrasound	Up to 30 participants with no disabilities will be recruited.

Functional Electrical Stimulation (Device): Functional electrical stimulation will be applied to the ankle muscles. The resulting torque will be collected, and ultrasound data will be obtained during stimulation.
Transcutaneous (Non-Invasive) Spinal Cord Stimulation (Device): Non-invasive spinal cord stimulation will be applied. The resulting torque data will be collected, and ultrasound data will be obtained during stimulation.
Ultrasound (Device): Ultrasound data will be collected from the shin muscles during FES and tSCS.

+Outcome measures

Primary outcomes

Ankle Joint Torque [Through study completion, estimated 12 months]: Ankle joint torque will be collected during stimulation with FES, with tSCS, and with FES + tSCS. We will compare the torque elicited by each simulation case.
Ultrasound-Derived Muscle Activation [Through study completion, estimated 12 months]: Ultrasound data will be collected from the shin muscles during FES, tSCS, and FES + tSCS. Muscle activation will be extracted from this data, and activation levels will be compared across stimulation cases.

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

* Between 18 and 60 years of age
* Weight less than 220 lb
* Healthy and able to walk at preferred speed without an assistive device
* Able to tolerate functional electrical stimulation and tSCS.

Exclusion Criteria:

* Active infection
* history of cancer,
* broken skin, sores, or areas of acute eczema near the electrode sites
* metal implants, such as staples or pins, near the electrode sites
* any neurological disorders
* difficulty walking or an orthopedic condition that would impede walking normally without assistance
* absent sensation in the lower extremities or trunk (torso),
* allergies to adhesive skin tapes and/or ultrasound gels,
* heart conditions
* an implanted electronic device such as a pacemaker
* current pregnancy
* having no physiological response to FES and/or tSCS.

+Locations (1)

Facility	City	Country	Status
Engineering Building III	Raleigh, North Carolina	United States	Recruiting