Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT07206797

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

Led by North Carolina State University · Updated on 2025-10-14

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

N

North Carolina State University

Lead Sponsor

U

University of North Carolina, Chapel Hill

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 transcutaneous spinal cord stimulation
Not Eligible

You will not qualify if you...

  • Active infection
  • History of cancer
  • Broken skin, sores, or areas of acute eczema near electrode sites
  • Metal implants such as staples or pins near electrode sites
  • Any neurological disorders
  • Difficulty walking or orthopedic conditions that impede normal walking
  • Absent sensation in lower extremities or trunk
  • Allergies to adhesive skin tapes or ultrasound gels
  • Heart conditions
  • Implanted electronic devices such as pacemaker
  • Current pregnancy
  • No physiological response to functional electrical stimulation or transcutaneous spinal cord stimulation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Engineering Building III

Raleigh, North Carolina, United States, 27695

Actively Recruiting

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Research Team

N

Nitin Sharma, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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