Ultrasound for Quantifying Muscle Activation Elicited by Spinal Cord Stimulation and Functional Electrical Stimulation

NCT ID: NCT07206797

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuromodulatory Effects of TSCS and FES in Lower Limbs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects without Disability

Up to 30 participants with no disabilities will be recruited.

Group Type EXPERIMENTAL

Functional Electrical Stimulation

Intervention Type DEVICE

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

Intervention Type DEVICE

Non-invasive spinal cord stimulation will be applied. The resulting torque data will be collected, and ultrasound data will be obtained during stimulation.

Ultrasound

Intervention Type DEVICE

Ultrasound data will be collected from the shin muscles during FES and tSCS.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Ultrasound

Ultrasound data will be collected from the shin muscles during FES and tSCS.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

North Carolina State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nitin Sharma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Engineering Building III

Raleigh, North Carolina, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nitin Sharma, Ph.D.

Role: CONTACT

919-513-0787

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nitin Sharma, Ph.D.

Role: primary

919-513-0787

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24815

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tACS for Neuropathic Pain Management After SCI
NCT06029075 NOT_YET_RECRUITING NA