Neuromodulatory Effects of TSCS and FES in Lower LimbsNCT07206797
Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
A study testing Functional Electrical Stimulation, Transcutaneous (Non-Invasive) Spinal Cord Stimulation and Ultrasound in people with Neuromodulatory Effects of TSCS and FES in Lower Limbs, run by North Carolina State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromodulatory Effects of TSCS and FES in Lower Limbs
- What is being tested?
- Functional Electrical Stimulation, Transcutaneous (Non-Invasive) Spinal Cord Stimulation and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Engineering Building III
Raleigh, North Carolina, 27695
Nitin Sharma, Ph.D., 919-513-0787, nsharm23@ncsu.edu
About this study
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.
- Being tested
- Functional Electrical Stimulation, Transcutaneous (Non-Invasive) Spinal Cord Stimulation, Ultrasound
- Keywords
- Ultrasound, Spinal Stimulation, Functional Electrical Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
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 StimulationDevice
Non-invasive spinal cord stimulation will be applied. The resulting torque data will be collected, and ultrasound data will be obtained during stimulation.
UltrasoundDevice
Ultrasound data will be collected from the shin muscles during FES and tSCS.
| Study group | Role | What they receive |
|---|---|---|
| Subjects without Disability | Experimental | Up to 30 participants with no disabilities will be recruited. Receives: Device: Functional Electrical Stimulation; Device: Transcutaneous (Non-Invasive) Spinal Cord Stimulation; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, estimated 12 months
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.
Measured: Through study completion, estimated 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromodulatory Effects of TSCS and FES in Lower LimbsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Nitin Sharma, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206797
- Sponsor's protocol ID
- 24815
- Status last verified
- Oct 2025
- First submitted
- 26 Sep 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside of this research group. However, selected data may be published in academic journals, conference papers, or other publications. This data will be de-identified, and will not include the full set of data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation
- ClinicalTrials.gov ID
- NCT07206797
- Acronym / sponsor ID
- 24815
- Keywords
- Ultrasound, Spinal Stimulation, Functional Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects without Disability | Experimental | Device: Functional Electrical Stimulation, Device: Transcutaneous (Non-Invasive) Spinal Cord Stimulation, Device: UltrasoundUp to 30 participants with no disabilities will be recruited. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical StimulationFunctional electrical stimulation will be applied to the ankle muscles. The resulting torque will be collected, and ultrasound data will be obtained during stimulation. | Device | Subjects without Disability |
| Transcutaneous (Non-Invasive) Spinal Cord StimulationNon-invasive spinal cord stimulation will be applied. The resulting torque data will be collected, and ultrasound data will be obtained during stimulation. | Device | Subjects without Disability |
| UltrasoundUltrasound data will be collected from the shin muscles during FES and tSCS. | Device | Subjects without Disability |
Primary outcome
Ankle Joint Torque
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No. IPD will not be shared outside of this research group. However, selected data may be published in academic journals, conference papers, or other publications. This data will be de-identified, and will not include the full set of data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation, Transcutaneous (Non-Invasive) Spinal Cord Stimulation and Ultrasound in people with Neuromodulatory Effects of TSCS and FES in Lower Limbs, run by North Carolina State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Sharma, Ph.D. (919-513-0787, nsharm23@ncsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Joint Torque (time frame: Through study completion, estimated 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.