NCT07206797 Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
| NCT ID | NCT07206797 |
| Status | Recruiting |
| Phase | — |
| Sponsor | North Carolina State University |
| Condition | Neuromodulatory Effects of TSCS and FES in Lower Limbs |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07206797 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Neuromodulatory Effects of TSCS and FES in Lower Limbs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07206797 currently recruiting?
Yes, NCT07206797 is actively recruiting participants. Contact the research team at nsharm23@ncsu.edu for enrollment information.
Where is the NCT07206797 trial being conducted?
This trial is being conducted at Raleigh, United States.
Who is sponsoring the NCT07206797 clinical trial?
NCT07206797 is sponsored by North Carolina State University. The trial plans to enroll 30 participants.