Engineering Building III
Raleigh, North Carolina, 27695, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07206797
Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
functional electrical stimulation
DeviceFunctional 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
DeviceNon-invasive spinal cord stimulation will be applied. The resulting torque data will be collected, and ultrasound data will be obtained during stimulation.
Ultrasound
DeviceUltrasound data will be collected from the shin muscles during FES and tSCS.
Primary outcomes
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Ankle Joint Torque
Time frame: 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.
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Ultrasound-Derived Muscle Activation
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
North Carolina State University
Other
Collaborators
- University of North Carolina, Chapel Hill
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Oct 3, 2025
- Registry last updated
- Oct 14, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.