30 Participants Needed

Spinal Cord + Electrical Stimulation for Muscle Activity

NS
Overseen ByNitin Sharma, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: North Carolina State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different types of electrical stimulation can activate muscles in people without disabilities. Researchers are testing two methods: a non-invasive technique called transcutaneous spinal cord stimulation (tSCS) and another called functional electrical stimulation (FES), to assess their effects on muscle activity at the ankle. They will also test the combination of both methods to determine if it leads to better results. Healthy individuals who can walk unaided and are comfortable with the stimulation methods may be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to innovative research in muscle activation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for muscle activity in spinal cord injury patients?

Research has shown that Functional Electrical Stimulation (FES) is safe for individuals with spinal cord injuries. Studies have found that FES can safely activate muscles, even for those with walking difficulties. People with multiple sclerosis have also used FES safely to exercise their muscles.

For Transcutaneous Spinal Cord Stimulation (tSCS), several studies suggest it is a safe, non-invasive method to assist with muscle activity. Safety checks during these studies revealed no major problems, and participants generally tolerated the treatment well. This method has been explored as a safe option for aiding recovery from spinal cord injuries.

Both treatments have been tested in various settings and found to be safe. Participants in these studies did not report any serious side effects, making these promising options for those considering joining a trial.12345

Why are researchers excited about this trial?

Researchers are excited about Functional Electrical Stimulation (FES) and Transcutaneous Spinal Cord Stimulation because these techniques offer a non-invasive way to activate muscle activity. Unlike current treatments that may rely on invasive surgical procedures or medications that can have significant side effects, these methods use electrical currents applied externally to stimulate the spinal cord and muscles. This new approach could potentially enhance muscle function without the risks associated with surgery or pharmaceuticals, offering a safer and possibly more effective option for improving muscle activity.

What evidence suggests that combining tSCS and FES could be effective for muscle activation in spinal cord injury?

Research has shown that Functional Electrical Stimulation (FES), a treatment in this trial, can strengthen muscles weakened by spinal cord injuries. Studies indicate that FES can increase muscle size and strength, especially in muscles used for walking. This suggests that FES might help people regain some muscle control and movement.

Transcutaneous Spinal Cord Stimulation (tSCS), another treatment option in this trial, also shows promise. Research has found that it can improve movement in the arms and legs, aiding those with spinal cord injuries. When combined with activity-based training, tSCS has enhanced muscle strength and walking ability.

Evidence suggests that using FES and tSCS together, as explored in this trial, might activate muscles more effectively than using either one alone. This combination could significantly improve movement and muscle function for individuals with spinal cord injuries.678910

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injury who may have weakened or paralyzed muscles. It's designed to test if non-invasive treatments can help activate these muscles. Participants should be able to undergo ultrasound and electrical stimulation safely.

Inclusion Criteria

Able to tolerate functional electrical stimulation and tSCS.
I can walk on my own without needing help.
I am between 18 and 60 years old.
See 1 more

Exclusion Criteria

An implanted electronic device such as a pacemaker
Current pregnancy
Having no physiological response to FES and/or tSCS.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transcutaneous spinal cord stimulation (tSCS) and functional electrical stimulation (FES) to quantify ankle joint torque and muscle activation

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Functional Electrical Stimulation
  • Transcutaneous (Non-Invasive) Spinal Cord Stimulation
  • Ultrasound
Trial Overview The study is testing how well transcutaneous spinal cord stimulation (tSCS) and functional electrical stimulation (FES), both separately and combined, can activate muscles as measured by the movement they produce at the ankle joint. Ultrasound imaging will also be used to assess muscle activity.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Subjects without DisabilityExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials
38
Recruited
50,000+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

Citations

Therapeutic Effects of Functional Electrical Stimulation on ...We found that FES restored weakened dorsiflexor and hip abductor strength during the swing and stance phases of gait, respectively, to help ...
A systematic review on functional electrical stimulation ...The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb ...
Effect of Functional Electrical Stimulation on Muscle Mass ...All variables showed statistically significant improvement immediately and 1 month after the intervention in the real FES group (P < .05). However, the tibialis ...
Effectiveness of Multichannel Functional Electrical ...The purpose of this pilot study is to determine whether two weeks of multi-channel FES along with task-specific training will improve UE function.
Functional Electrical Stimulation in Muscle RehabilitationA rehabilitation technique that uses electrical impulses to evoke muscle contractions, aiding in the recovery or maintenance of muscle function.
Safety and Feasibility of Various Functional Electrical ...People with multiple sclerosis who are nonambulatory can safely perform functional electrical stimulation (FES) cycling using parameters requiring more effort.
Feasibility and safety of automated multi-channel FES ...Our results show that automated multi-channel FES-assisted gait training is both feasible and safe for individuals with iSCI.
Upper Extremity Muscle Recovery Profiles With Functional ...For example, a recent safety and efficacy trial on noninvasive spinal cord neuromodulation indicated improvements in arm and hand function in ...
Functional Electrical Stimulation (FES) Driven Stepping in ...The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that ...
Neuromuscular Electrical Stimulation (NMES) for Spinal ...These devices use electrical impulses to activate paralyzed or weak muscles in precise sequence and have been utilized to provide SCI patients with the ability ...
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