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

Not Applicable

Recruiting

• Conditions: Neuromodulatory Effects of TSCS and FES in Lower Limbs

• Registration Number: NCT07206797
• Lead Sponsor: North Carolina State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Status Verified: 2025-10
• Study First Posted: 2025-10-03
• Last Update Submitted: 2025-10-09
• Last Update Posted: 2025-10-14
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Engineering Building III; 🇺🇸 Raleigh, North Carolina, United States