Ultrasound measurement of muscle activation from non-invasive spinal and muscle electrical stimulation
Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
We will test whether ultrasound can measure muscle activity and compare ankle torque produced by non-invasive spinal stimulation, electrical muscle stimulation, and both together in adults who can walk without assistance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | North Carolina State University Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT07206797 on ClinicalTrials.gov |
What this trial studies
This interventional protocol applies transcutaneous spinal cord stimulation (tSCS), functional electrical stimulation (FES), and the two combined while recording ultrasound images and measuring ankle joint torque. Healthy adults who are 18–60 years old, weigh less than 220 lb, and can walk unaided will undergo stimulation sessions with simultaneous ultrasound and torque measurements. The project quantifies torque produced by each stimulation condition and analyzes ultrasound-derived muscle motion as a metric of activation. Correlations between ultrasound signals and torque will determine whether ultrasound provides a reliable, noninvasive measure of stimulation-elicited muscle activity.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18–60 who weigh under 220 lb, can walk at their preferred speed without assistive devices, and can tolerate FES and tSCS.
Not a fit: People with neurological disorders, absent lower-extremity sensation, implanted electronic devices or metal near electrode sites, active infections, pregnancy, or no physiological response to FES/tSCS are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this work could provide a noninvasive way to measure and monitor muscle activation during spinal and muscle electrical stimulation, helping tailor therapies without implants.
How similar studies have performed: Prior work shows tSCS and FES can activate muscles and that combining them can increase activation, but using ultrasound as a quantitative measure of tSCS-elicited activity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Raleigh, North Carolina
- Engineering Building III — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Nitin Sharma, Ph.D.
- Email: nsharm23@ncsu.edu
- Phone: 919-513-0787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.