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

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous Spinal Stimulation for Spina Bifida?

A case report showed that an infant with spina bifida experienced unexpected improvements in sensation and movement after receiving transcutaneous spinal stimulation, suggesting potential benefits. Additionally, a study on transcutaneous electro-stimulation in children with spina bifida showed trends of improvement in bladder function, although not statistically significant. ^{1 2 3 4 5}

Is transcutaneous spinal stimulation safe for humans?

Transcutaneous spinal stimulation has been found to be generally safe and well-tolerated in both infants and children with spinal cord conditions, including spina bifida and spinal cord injury. In one study, it enabled upright posture in 7 out of 8 children, with only one participant experiencing pain and another having a temporary episode of autonomic dysreflexia (a sudden increase in blood pressure). ^{1 2 6 7 8}

How does transcutaneous spinal stimulation differ from other treatments for spina bifida?

Transcutaneous spinal stimulation is unique because it is a non-invasive treatment that uses electrical currents applied through the skin to stimulate the spinal cord, potentially improving sensory and motor functions. Unlike other treatments that may require surgery or medication, this method is applied externally and has shown promise in promoting spontaneous movements and sensory responses in children with spina bifida. ^{1 2 5 9 10}

What is the purpose of this trial?

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

Research Team

Kristin Zhao, Ph.D.

Principal Investigator

Mayo Clinic

Joline Brandenburg, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Exploratory Electrical Stimulation Protocol in the Management of an Infant With Spina Bifida: A Case Report. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Altered bladder and bowel function following cutaneous electrical field stimulation in children with spina bifida--interim results of a randomized double-blind placebo-controlled trial. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Infants with spina bifida: immediate responses to contextual and manual sensory augmentation during treadmill stepping. [2013]

4. India pubmed.ncbi.nlm.nih.gov

Malaysian children with spina bifida: relationship between functional outcome and level of lesion. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation in Management of Neurogenic bladder Secondary to Spina Bifida. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Noninvasive spinal stimulation safely enables upright posture in children with spinal cord injury. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of sacral neuromodulation on neurogenic bladder and bowel dysfunction in patients with spina bifida]. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Experiences and critical comments on the temporary intravesical electrostimulation of the neurogenic bladder in spina bifida children. [2018]