Neuromodulatory Effects of TSCS and FES in Lower Limbs
Conditions
Keywords
Ultrasound, Spinal Stimulation, Functional Electrical Stimulation
Brief summary
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
DEVICEFunctional 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.
DEVICETranscutaneous (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.
DEVICEUltrasound
Ultrasound data will be collected from the shin muscles during FES and tSCS.
Sponsors
University of North Carolina, Chapel Hill
North Carolina State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Joint Torque | Through study completion, estimated 12 months | 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. |
| Ultrasound-Derived Muscle Activation | Through study completion, estimated 12 months | 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. |
Countries
United States
Contacts
Primary ContactNitin Sharma, Ph.D.
Outcome results
None listed