Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
NCT ID: NCT07206797
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-06-01
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Subjects without Disability
Up to 30 participants with no disabilities will be recruited.
Functional Electrical Stimulation
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
Non-invasive spinal cord stimulation will be applied. The resulting torque data will be collected, and ultrasound data will be obtained during stimulation.
Ultrasound
Ultrasound data will be collected from the shin muscles during FES and tSCS.
Interventions
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Functional Electrical Stimulation
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
Non-invasive spinal cord stimulation will be applied. The resulting torque data will be collected, and ultrasound data will be obtained during stimulation.
Ultrasound
Ultrasound data will be collected from the shin muscles during FES and tSCS.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
North Carolina State University
OTHER
Responsible Party
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Nitin Sharma
Principal Investigator
Locations
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Engineering Building III
Raleigh, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24815
Identifier Type: -
Identifier Source: org_study_id
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