Myelomeningocele, Spina Bifida
Conditions
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.
Interventions
DS8R (Digitimer LLC) for transcutaneous neurostimulation.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coordination | 1 to 12 visits (up to 6 weeks) | Coordination will be reported with the Selective Control Assessment of the Lower Extremity (SCALE) total limb score for both right and left leg. Total score for each limb is 10, with a higher score indicating coordination closer to optimal. |
| Manual muscle testing (MMT) | 1 to 12 visits (up to 6 weeks) | 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. |
| Spasticity (1) | 1 to 12 visits (up to 6 weeks) | Change in measurement of leg muscle tone utilizing the Modified Ashworth Scale (MAS). A physical therapist will use a 5-point scale to assess resistance of major muscles during passive range of motion, with a lower score for a muscle indicating less tone. MAS for 4 muscle groups in each leg will be reported. |
| Spasticity (2) | 1 to 12 visits (up to 6 weeks) | Change in measurements of leg muscle tone utilizing Wartenberg's pendulum test, with the first swing angle (FSA) degrees as the primary outcome. Fewer degrees on swing angle indicating greater spasticity. |
| Gait | 1 to 12 visits (up to 6 weeks) | Gait speed will be quantified in m/sec utilizing a motion capture system, with faster gait speed indicating less impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electromyography (EMG) | 1 to 12 visits (up to 6 weeks) | TS-evoked motor potential (MEP) amplitude, in millivolts, will be reported for major lower limbs muscles. An increase in MEP amplitude is indicative of greater muscle activation, closer to optimal function. |
Countries
United States
Contacts
Primary ContactJulie Block
Outcome results
None listed