Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional Electrical Stimulation, Transcutaneous (Non-Invasive) Spinal Cord Stimulation, Ultrasound.
- Who it may be relevant to
- Registry conditions: Neuromodulatory Effects of TSCS and FES in Lower Limbs. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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. - Device 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. - Device Ultrasound
Ultrasound data will be collected from the shin muscles during FES and tSCS.
Primary outcome measures
- Ankle Joint Torque [Time frame: Through study completion, estimated 12 months]
- Ultrasound-Derived Muscle Activation [Time frame: Through study completion, estimated 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Engineering Building III — Raleigh
Identifiers
NCT: NCT07206797 · 24815