MyelomeningoceleNCT06918119
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
A study testing Transcutaneous stimulation in people with Myelomeningocele and Spina Bifida, run by Mayo Clinic at 1 site in United States.
Trial summary
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Myelomeningocele, Spina Bifida
- What is being tested?
- Transcutaneous stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Kristin D Zhao, Ph.D, 507-284-8942, Zhao.Kristin@mayo.edu
About this study
Official title: Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida
A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
Read the 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.
- Conditions
- Myelomeningocele, Spina Bifida
- Being tested
- Transcutaneous stimulation
- Medical subject headings
- Meningomyelocele, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous stimulationDevice
DS8R (Digitimer LLC) for transcutaneous neurostimulation.
| Study group | Role | What they receive |
|---|---|---|
| Functional motor training with transcutaneous spinal cord stimulation | Experimental | Transcutaneous spinal cord stimulation will be delivered to the skin over the lower thoracic and lumbar spine region using adhesive electrodes for ages 5-11 for one multi-hour visit. The effects of stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures. Receives: Device: Transcutaneous stimulation |
| Extended functional motor training with transcutaneous spinal cord stimulation | Experimental | An extended functional training arm for a subset of 10 subjects, ages 12-18, in which they will receive up to twelve multi-hour sessions of a therapeutic neuromuscular strengthening intervention within a 6 week period. Receives: Device: Transcutaneous stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 to 12 visits (up to 6 weeks)
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.
Measured: 1 to 12 visits (up to 6 weeks)
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.
Measured: 1 to 12 visits (up to 6 weeks)
Gait
Gait speed will be quantified in m/sec utilizing a motion capture system, with faster gait speed indicating less impairment.
Measured: 1 to 12 visits (up to 6 weeks)
Coordination
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.
Measured: 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.
Measured: 1 to 12 visits (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start7 Aug 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomeningoceleStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Zhao, PhD, Mayo Clinic
- Investigators
- Kristin Zhao, Ph.D., Principal investigator, Mayo ClinicJoline Brandenburg, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918119
- Sponsor's protocol ID
- 24-006063
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida
- ClinicalTrials.gov ID
- NCT06918119
- Acronym / sponsor ID
- 24-006063
- Conditions
- Myelomeningocele, Spina Bifida
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional motor training with transcutaneous spinal cord stimulation | Experimental | Device: Transcutaneous stimulationTranscutaneous spinal cord stimulation will be delivered to the skin over the lower thoracic and lumbar spine region using adhesive electrodes for ages 5-11 for one multi-hour visit. The effects of stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures. |
| Extended functional motor training with transcutaneous spinal cord stimulation | Experimental | Device: Transcutaneous stimulationAn extended functional training arm for a subset of 10 subjects, ages 12-18, in which they will receive up to twelve multi-hour sessions of a therapeutic neuromuscular strengthening intervention within a 6 week period. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous stimulationDS8R (Digitimer LLC) for transcutaneous neurostimulation. | Device | Extended functional motor training with transcutaneous spinal cord stimulation, Functional motor training with transcutaneous spinal cord stimulation |
Primary outcome
Manual muscle testing (MMT)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Coordination
Time frame: 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.
1 secondary outcome
Electromyography (EMG)
Time frame: 1 to 12 visits (up to 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Zhao, Ph.D. principal investigator
Mayo Clinic
Joline Brandenburg, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous stimulation in people with Myelomeningocele and Spina Bifida, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candee Mills (507-255-7253, Mills.Candee@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual muscle testing (MMT) (time frame: 1 to 12 visits (up to 6 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.