Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

Mayo Clinic

Status: Enrolling

Conditions: Spina Bifida; Myelomeningocele

Treatments: Device: Transcutaneous stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06918119

24-006063

Details and patient eligibility

About

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

Full description

The study's goals involve understanding how transcutaneous stimulation affects motor deficits across three dimensions; weakness, coordination, and spasticity. This will be investigated by an electrophysiological characterization lower-extremity deficits, using TS to interrogate neuromotor topography and connectivity of the spinal cord to specific muscles. These evaluations will enable a unique patient-specific understanding of the electrophysiological mechanisms underlying motor deficits. Furthermore, these evaluations will assess the therapeutic potential of a novel closed-loop TS plasticity induction protocol to strengthen weakened muscles in a pediatric SB population.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Congenital diagnosis of myelomeningocele (MMC)
• Able to follow verbal commands or instructions.
• If female and able to become pregnant, must be willing to use medically-acceptable method of contraception during study participation.

Exclusion Criteria

• Severe cognitive deficits demonstrating inability to communicate needs
• Gaping, weeping, or unhealed open wounds at the site of electrode placement
• Unhealed fractures on load bearing bones
• History of osteoporosis
• History of implanted electronic devices at the stimulation location(e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, baclofen pumps, insulin pumps, etc.)
• Pregnancy
• Epilepsy
• History of seizure
• Ongoing infections (currently being treated or are symptomatic)
• Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Functional motor training with transcutaneous spinal cord stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous stimulation

Extended functional motor training with transcutaneous spinal cord stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous stimulation