Clinical trial NCT06918119: Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Official title: Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myelomeningocele
Spina Bifida
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility 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
* 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.

Primary outcomes:
measure: Manual muscle testing (MMT)
timeFrame: 1 to 12 visits (up to 6 weeks)
measure: Spasticity (1)
timeFrame: 1 to 12 visits (up to 6 weeks)
measure: Spasticity (2)
timeFrame: 1 to 12 visits (up to 6 weeks)
measure: Gait
timeFrame: 1 to 12 visits (up to 6 weeks)
measure: Coordination
timeFrame: 1 to 12 visits (up to 6 weeks)
Secondary outcomes:
measure: Electromyography (EMG)
timeFrame: 1 to 12 visits (up to 6 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kristin Zhao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Joline Brandenburg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: