Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNorth Carolina State University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Subjects without DisabilityExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Ankle Joint Torque

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.

Time frame
Through study completion, estimated 12 months
2

Ultrasound-Derived Muscle Activation

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.

Time frame
Through study completion, estimated 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

North Carolina State University

Lead sponsor

University of North Carolina, Chapel Hill

Collaborator