Transcutaneous Spinal Stimulation for Spina Bifida

Overseen By Julie Block

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Epilepsy, Seizure, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help children with spina bifida improve movement. It uses transcutaneous spinal stimulation, which sends small electrical signals through the skin to the spine. The trial consists of two parts: one for younger children (ages 5-11) with a single session, and another for older children (ages 12-18) with multiple sessions over six weeks. Children with a congenital form of spina bifida called myelomeningocele, who can follow instructions, may be suitable for this study. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from an innovative treatment approach.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team to understand any specific requirements.

What prior data suggests that transcutaneous spinal stimulation is safe for children with spina bifida?

Studies have shown that transcutaneous spinal stimulation is generally safe and well-tolerated. For example, research with children aged 3 to 15 found that the treatment helped them sit upright without major problems. Another study found short-term use of this treatment in children with spinal cord injuries to be safe and practical, with no serious side effects reported.

Additionally, a review of studies on a similar treatment, transcutaneous electrical stimulation, has confirmed its safety for certain conditions after spinal cord injuries. Although the current study on spina bifida does not yet have specific safety data, these findings suggest that transcutaneous spinal stimulation is likely a safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Spinal Stimulation for spina bifida is unique because it offers a non-invasive approach to enhancing motor function by applying electrical stimulation through the skin over the spine. Unlike traditional options that might involve surgery or medication, this method directly targets the spinal cord to potentially improve nerve and muscle activity. Researchers are excited about this treatment because it could provide a safer, less invasive alternative with fewer side effects, especially for young patients, and might lead to quicker improvements in mobility and strength. Additionally, the extended training arm for older children and teens involves multiple sessions, which could amplify the benefits and offer insights into long-term improvements.

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

Research has shown that transcutaneous spinal stimulation may improve leg movements and posture in both children and adults. In this trial, participants will receive transcutaneous spinal stimulation as part of functional motor training. Studies have found this technique particularly effective for children with bladder issues and spina bifida, suggesting it could also aid movement and sensation. This non-invasive method does not require surgery. It uses electrical currents applied to the skin to stimulate the spinal cord, potentially enhancing muscle function and control. Early research indicates that this technique is safe and well-tolerated in children. Overall, these initial findings offer hope for improving movement and strength in people with spina bifida. ^{1 2 3 5 6}

Who Is on the Research Team?

Kristin Zhao, Ph.D.

Principal Investigator

Mayo Clinic

Joline Brandenburg, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for children and youth with a congenital condition called myelomeningocele, a form of spina bifida. Participants must be able to understand instructions and, if female with childbearing potential, agree to use contraception. Excluded are those with conditions affecting study compliance or data validity, unhealed fractures or wounds, infections, severe cognitive issues preventing communication of needs, pregnancy, history of implanted electronic devices at the stimulation site or seizures.

Inclusion Criteria

I was born with myelomeningocele.

I am willing to use birth control during the study.

I can understand and follow spoken instructions.

Exclusion Criteria

I don't have any health issues that would stop me from following the study rules.

I have fractures in my weight-supporting bones that haven't healed.

I do not have any current infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Functional Motor Training

Transcutaneous spinal cord stimulation delivered to the skin over the lower thoracic and lumbar spine region using adhesive electrodes for ages 5-11 for one multi-hour visit.

1 visit

1 visit (in-person)

Extended Functional Motor Training

Extended functional training for ages 12-18, receiving up to twelve multi-hour sessions of a therapeutic neuromuscular strengthening intervention.

6 weeks

Up to 12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Stimulation

Trial Overview The trial is testing transcutaneous spinal cord stimulation in pediatric patients with spina bifida to assess sensorimotor deficits. It aims to understand how this non-invasive treatment can influence motor functions and sensory processing in affected individuals.

How Is the Trial Designed?

Group I: Functional motor training with transcutaneous spinal cord stimulation Experimental Treatment 1 Intervention

Transcutaneous spinal cord stimulation will be delivered to the skin over the lower thoracic and lumbar spine region using adhesive electrodes for ages 5-11 for one multi-hour visit. The effects of stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

Group II: Extended functional motor training with transcutaneous spinal cord stimulation Experimental Treatment 1 Intervention

An extended functional training arm for a subset of 10 subjects, ages 12-18, in which they will receive up to twelve multi-hour sessions of a therapeutic neuromuscular strengthening intervention within a 6 week period.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

An infant with myelomeningocele showed unexpected improvements, including somatosensory responses and spontaneous movements in the trunk and lower extremities after 12 months of electrical stimulation treatment, which included functional and transcutaneous spinal cord stimulation.

Both electrical stimulation protocols were found to be safe and well tolerated, marking a novel approach in the management of children with spina bifida, as such treatments had not been previously documented in medical literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Electrical Stimulation Protocol in the Management of an Infant With Spina Bifida: A Case Report. Motavalli, G., McElroy, JJ., Alon, G.[2020]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

Transcutaneous electrical nerve stimulation (TENS) combined with anticholinergic drugs significantly improved symptoms of neurogenic bladder in patients with spina bifida, leading to a notable reduction in wet episodes per day and improved bladder function metrics.

In a study of 40 patients, those receiving TENS with anticholinergic medications (Group C) showed the greatest improvements in detrusor pressure, bladder compliance, and capacity compared to those receiving placebo treatments or TENS alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation in Management of Neurogenic bladder Secondary to Spina Bifida. Pattanshetti, S., Mahajan, JK., Saxena, S., et al.[2022]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

Sacral neuromodulation (SNM) was found to be effective in treating neurogenic bladder and bowel dysfunction in 33 patients with spina bifida, achieving a success rate of approximately 69.7% during a 14-28 day experiential treatment period without complications.

Patients experienced significant improvements in urinary symptoms, such as reduced urgency and leakage, as well as enhanced urodynamic parameters, indicating that SNM can help prevent upper urinary tract damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of sacral neuromodulation on neurogenic bladder and bowel dysfunction in patients with spina bifida]. Chen, G., Wang, Y., Ying, X., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9936896/

Transcutaneous Spinal Stimulation From Adults to Children Early studies of scTS at thoracolumbar, coccygeal, and cervical regions have demonstrated its effectiveness in producing voluntary leg movements, posture ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06918119

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.

3. journals.lww.com journals.lww.com/md-journal/fulltext/2018/10120/a_systematic_review_of_clinical_studies_on.78.aspx

A systematic review of clinical studies on electrical... Han et al reported that the use of intravesical electrical stimulation therapy was effective in children aged 3.9 to 13.2 years old with NBD and spina bifida.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203582/

A systematic review of clinical studies on electrical stimulation ... Han et al reported that the use of intravesical electrical stimulation therapy was effective in children aged 3.9 to 13.2 years old with NBD ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/2329048X19835656

An Exploratory Electrical Stimulation Protocol in the ... Both functional and spinal cord electrical stimulation protocols used with this infant proved safe and well tolerated.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1094715923006487

Safety and Feasibility of Cervical and Thoracic ... We indicated that short-term application of scTS via two cervical and one thoracic site is safe and feasible in children with SCI and resulted in immediate ...