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

NCT07206797 | Recruiting

• 1 other identifier: 24815
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromodulatory Effects of TSCS and FES in Lower Limbs

Keywords

Ultrasound; Spinal Stimulation; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• Ankle Joint Torque

  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.

  Through study completion, estimated 12 months

• Ultrasound-Derived Muscle Activation

  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.

  Through study completion, estimated 12 months

Study Arms (1)

Subjects without Disability

EXPERIMENTAL

Up to 30 participants with no disabilities will be recruited.

Device: Functional Electrical Stimulation; Device: Transcutaneous (Non-Invasive) Spinal Cord Stimulation; Device: Ultrasound

Interventions

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.

Subjects without Disability

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.

Subjects without Disability

Ultrasound DEVICE

Ultrasound data will be collected from the shin muscles during FES and tSCS.

Subjects without Disability

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Carolina State University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Engineering Building III

Raleigh, North Carolina, 27695, United States

RECRUITING

MeSH Terms

Interventions

Spinal Cord Stimulation; Ultrasonography

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Nitin Sharma, Ph.D.

CONTACT

919-513-0787; nsharm23@ncsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)