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 — 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.
  • 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.
  • Ultrasound — DEVICE
    Ultrasound 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 Disability
    Up 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

Locations (1)

FacilityCityStateZIPSite coordinators
Engineering Building IIIRaleighNorth Carolina27695
Nitin Sharma, Ph.D.
919-513-0787

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