20 Participants NeededMy employer runs this trial

Transcutaneous Stimulation for Spina Bifida

SB
Overseen BySydney Bader, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Bailey Petersen
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 explores whether transcutaneous spinal cord stimulation, which uses electrical currents applied through the skin to stimulate the spinal cord, can enhance leg muscle strength and walking ability in children with myelomeningocele, a type of spina bifida. The researchers aim to determine if this treatment can improve walking, even with assistance or devices. It suits children diagnosed with myelomeningocele who experience some difficulty walking and have a stable bladder management routine. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from an innovative treatment approach.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be on a stable bladder management regimen for at least 4-6 weeks before joining the trial.

What prior data suggests that transcutaneous spinal cord stimulation is safe for children with myelomeningocele?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is safe and well-tolerated in children with spina bifida. In earlier studies, children who received this treatment did not experience negative side effects. Some children even reported almost complete pain relief and improved movement abilities without issues. Other research supports the safety of this method, noting its successful use in adults with spinal cord injuries to enhance muscle strength and control, again without harmful side effects. Overall, the evidence suggests that tSCS is a promising and safe option for managing spina bifida symptoms in children.12345

Why are researchers excited about this trial?

Unlike the standard care options for spina bifida, such as surgery or physical therapy, Transcutaneous Spinal Cord Stimulation (tSCS) offers a non-invasive approach that stands out. This treatment works by delivering electrical currents through the skin to stimulate the spinal cord, potentially enhancing nerve function and mobility without the need for surgery. Researchers are excited about tSCS because it could offer a safer and more accessible alternative, with less recovery time and fewer risks, providing new hope for improved quality of life for those with spina bifida.

What evidence suggests that transcutaneous spinal cord stimulation is effective for spina bifida?

Studies have shown that transcutaneous spinal cord stimulation (tSCS), which sends electrical signals through the skin to the spinal cord, may improve leg muscle function and walking speed in people with spinal cord injuries. In children with spina bifida, tSCS has effectively improved movement, sensation, and bladder issues. Research in both adults and children suggests that this non-invasive method can enhance motor control, helping people move their muscles better. Although more research is needed specifically for spina bifida, these findings suggest that tSCS could improve mobility and strength in affected children. This trial will provide all participants with transcutaneous spinal cord stimulation to evaluate its effectiveness further.23467

Who Is on the Research Team?

BP

Bailey Petersen, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children diagnosed with spina bifida, specifically those with myelomeningocele. Participants should be able to safely undergo non-invasive electrical stimulation and follow study instructions.

Inclusion Criteria

I am between 4 and 17 years old.
I have been diagnosed with neurogenic bladder dysfunction.
I have been using the same bladder management routine for at least 4 weeks.
See 2 more

Exclusion Criteria

Implanted or attached electronic device in any location of the body (e.g. pacemakers, baclofen pumps, implanted insulin pumps)
Is pregnant, assessed via verbal report
I do not have a current urinary tract infection or issues with catheterization.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation to improve motor deficits and bladder control

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Spinal Cord Stimulation (tSCS)

Trial Overview

The study is testing a device called a transcutaneous stimulator, which delivers mild electrical currents through the skin to stimulate the spinal cord. The goal is to see if this can improve leg strength and walking in children with spina bifida.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Transcutaneous SCSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bailey Petersen

Lead Sponsor

Citations

Effectiveness of transcutaneous spinal cord stimulation for ...

Current evidence suggests tSCS may improve lower limb motor function and walking speed in SCI, with a favorable safety profile.

Transcutaneous Spinal Stimulation for Spina Bifida

Studies have found this technique particularly effective for children with bladder issues and spina bifida, suggesting it could also aid movement and sensation.

tSCS in Children With Spina Bifida - ClinicalTrials.Veeva

Transcutaneous, or non-invasive, spinal cord stimulation (tSCS) has been effective at improving motor control, especially walking, ...

Transcutaneous Spinal Stimulation for Children and Youth ...

A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.

Safety and Feasibility of Cervical and Thoracic ...

In adults with cervical spinal cord injury (SCI), transcutaneous spinal stimulation (scTS) has improved upper extremity strength and control.

An Exploratory Electrical Stimulation Protocol in the ... - PMC

Spinal cord electrical stimulation protocols were not previously described in the medical literature regarding the management of children with spina bifida.

Resources - Spinal Stimulation - Gerti Motavalli PT, MPT

Both children achieved near-complete pain relief and significant restoration of motor function, with no adverse events. The study demonstrates that carefully ...