Recruiting

FES & tSCS

Sponsor:

North Carolina State University

Code:

NCT07206797

Conditions

Neuromodulatory Effects of TSCS and FES in Lower Limbs

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Functional Electrical Stimulation

Transcutaneous (Non-Invasive) Spinal Cord Stimulation

Ultrasound

Study Details

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.

Conditions

Neuromodulatory Effects of TSCS and FES in Lower Limbs

Study ID

NCT07206797

Start date

Jun 1, 2025

Status verified date

Oct, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Subjects without Disability

Up to 30 participants with no disabilities will be recruited.

Interventions

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.

Primary outcome measure

  • Ankle Joint Torque [ Time Frame: Through study completion, estimated 12 months ]
  • Ultrasound-Derived Muscle Activation [ Time Frame: Through study completion, estimated 12 months ]

Central Contacts and Locations

Central contacts

Nitin Sharma, Ph.D.

919-513-0787nsharm23@ncsu.edu

Locations

Engineering Building III

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

Nitin Sharma, Ph.D.

919-513-0787nsharm23@ncsu.edu

More Information

Sponsor

North Carolina State University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Ultrasound
  • Spinal Stimulation
  • Functional Electrical Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2025-10-14.