Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous stimulation.
- Who it may be relevant to
- Registry conditions: Myelomeningocele, Spina Bifida. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida
Overview
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.
Interventions
- Device Transcutaneous stimulation
DS8R (Digitimer LLC) for transcutaneous neurostimulation.
Primary outcome measures
- Manual muscle testing (MMT) [Time frame: 1 to 12 visits (up to 6 weeks)]
- Spasticity (1) [Time frame: 1 to 12 visits (up to 6 weeks)]
- Spasticity (2) [Time frame: 1 to 12 visits (up to 6 weeks)]
- Gait [Time frame: 1 to 12 visits (up to 6 weeks)]
- Coordination [Time frame: 1 to 12 visits (up to 6 weeks)]
Secondary outcome measures (1)
- Electromyography (EMG) [Time frame: 1 to 12 visits (up to 6 weeks)]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06918119 · 24-006063