Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

Mayo Clinic30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Myelomeningocele Spina Bifida

Interventions

Transcutaneous stimulationDEVICE

DS8R (Digitimer LLC) for transcutaneous neurostimulation.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Manual muscle testing (MMT)

Measuring muscle strength and function using the Daniels and Worthingham's Muscle Grading Scale. A physical therapist will use a 5-point scale to manually test the 5 lower extremity muscles on each side, with 0 being no visible or palpable contraction, up to 5 being full range of motion against gravity with maximal resistance. The maximum total score would be 50.