Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorMayo Clinic
About this trial
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Transcutaneous stimulation
DeviceDS8R (Digitimer LLC) for transcutaneous neurostimulation.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Functional motor training with transcutaneous spinal cord stimulationExperimental treatment 1 intervention
Group B: Extended functional motor training with transcutaneous spinal cord stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 to 12 visits (up to 6 weeks)2
Spasticity (1)
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.
Time frame
1 to 12 visits (up to 6 weeks)3
Spasticity (2)
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.
Time frame
1 to 12 visits (up to 6 weeks)4
Gait
Gait speed will be quantified in m/sec utilizing a motion capture system, with faster gait speed indicating less impairment.
Time frame
1 to 12 visits (up to 6 weeks)Secondary outcomes
1
Electromyography (EMG)
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.
Time frame
1 to 12 visits (up to 6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov