Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
Part of paid clinical trials in Raleigh, North Carolina.
- Sponsor
- North Carolina State University
- Study ID
- NCT07206797
- Status
- Recruiting
Conditions
- Neuromodulatory Effects of TSCS and FES in Lower Limbs
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- Jun 1, 2025
- Status verified
- Oct 2025
- Primary completion
- Jun 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Subjects without DisabilityUp to 30 participants with no disabilities will be recruited.
Primary Outcome Measure
Ankle Joint Torque [ Time Frame: Through study completion, estimated 12 months ]
Central Contacts
- Nitin Sharma, Ph.D.919-513-0787
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Engineering Building III | Raleigh | North Carolina | 27695 |