Spina BifidaNCT07615686
tSCS in Children With Spina Bifida
A study testing Transcutaneous stimulator in people with Spina Bifida and Myelomeningocele, run by Bailey Petersen at 1 site in United States.
Trial summary
A single-center, open-label, investigational pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Spina Bifida, Myelomeningocele
- What is being tested?
- Transcutaneous stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 10 Mar 2029
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed myelomeningocele confirmed by a neurosurgeon or neurologist
- Some difficulty ambulating, but able to ambulate at least a short distance (10 meters) with devices and/or assistance.
- Between the ages of 4 and 17 years of age.
- Documented neurogenic bladder dysfunction
- On a stable bladder management regimen at least 4-6 weeks prior to the enrollment in the trial
Who cannot join
- Severe behavioral or cognitive impairments that preclude participation in the study, in the opinion of the investigator.
- Has an active surgery planned for impairments from spina bifida (e.g. tethered cord syndrome surgery or orthopedic surgery) or has had surgery in the last 6 months.
- Is pregnant. Pregnancy will be assessed via verbal report.
- Open wounds at the thoracic or lumbar spine that precludes transcutaneous stimulation.
- Implanted or attached electronic device in any location of the body (e.g. pacemakers, baclofen pumps, or implanted insulin pumps)
- Symptomatic urinary tract infection, urinary tract infection for which they are currently receiving treatment, scheduled urological surgery, or inability to perform or receive catheterization.
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
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Sydney Bader, MS, syb17@pitt.edu
About this study
Official title: Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
A single-center, open-label, investigational pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele.
Read the detailed description
Transcutaneous, or non-invasive, spinal cord stimulation (tSCS) has been effective at improving motor control, especially walking, in adults with a variety of neuromuscular disorders and in children with spinal cord injury. Children with spina bifida often have similar difficulties with walking, muscle strength and bladder control throughout their lives, with few effective therapies to reliably improve walking. In this pilot, the investigators will test if tSCS can improve motor deficits and bladder control in children with spina bifida. The investigators are enrolling up to 20 subjects with myelomeningocele, ages 4-17 years old, that have some difficulty walking but can walk for even short distances with assistance, and that have bladder dysfunction with a stable bladder regimen. Over 4-6 weeks, children will have stimulation using non-invasive tSCS electrodes placed on their low back. Similar protocols have been used for tSCS in children with spinal cord injury and children with cerebral palsy. All previous tSCS studies have shown that this is a safe technology for use with pediatric populations. This pilot study will be used to refine the design of future randomized controlled trials to test tSCS over standard physical therapy care.
- Conditions
- Spina Bifida, Myelomeningocele
- Being tested
- Transcutaneous stimulator
- Keywords
- spina bifida, myelomeningocele
- Medical subject headings
- Spinal Dysraphism, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous stimulatorDevice
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous SCS | Experimental | All participants will be receiving transcutaneous spinal cord stimulation Receives: Device: Transcutaneous stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
change in isometric torque of quadriceps during knee extension
Measured: 4-6 weeks
Gait Kinematics
Change in joint angles in tSCS vs no stim conditions
Measured: 4-6 weeks
Bladder capacity
Change in cystometric bladder capacity with tSCS vs no stim conditions
Measured: 4-6 weeks
Gait Kinetics
Changes in ground reaction forces with and without stimulation
Measured: 4-6 weeks
Bladder Pressure
Change in voiding pressure with tSCS vs no stim conditions
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start30 Sep 2026 (estimated)
- Primary completion10 Mar 2028 (estimated)
- Study completion10 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bailey Petersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bailey Petersen, University of Pittsburgh
- Investigators
- Bailey Petersen, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615686
- Sponsor's protocol ID
- STUDY25100066
- Status last verified
- Sep 2026
- First submitted
- 22 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial may be shared with other researchers for the purpose of data analysis and collaboration.
Publications
Keller A, Singh G, Sommerfeld JH, King M, Parikh P, Ugiliweneza B, D'Amico J, Gerasimenko Y, Behrman AL. Noninvasive spinal stimulation safely enables upright posture in children with spinal cord injury. Nat Commun. 2021 Oct 6;12(1):5850. doi: 10.1038/s41467-021-26026-z.
PubMed 34615867Amirova L, Keller A, Singh G, King M, Parikh P, Stepp N, Ugiliweneza B, Gerasimenko Y, Behrman AL. Cumulative Transcutaneous Spinal Stimulation with Locomotor Training Safely Improves Trunk Control in Children with Spinal Cord Injury: Pilot Study. Children (Basel). 2025 Jun 21;12(7):817. doi: 10.3390/children12070817.
PubMed 40723009Neighbors E, Brunn L, Casamento-Moran A, Martin R. Transcutaneous Spinal Cord Stimulation Enables Recovery of Walking in Children with Acute Flaccid Myelitis. Children (Basel). 2024 Sep 12;11(9):1116. doi: 10.3390/children11091116.
PubMed 39334648Hastings S, Zhong H, Feinstein R, Zelczer G, Mitrovich C, Gad P, Edgerton VR. A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy. Nat Commun. 2022 Oct 5;13(1):5660. doi: 10.1038/s41467-022-33208-w.
PubMed 36198701Danielsson AJ, Bartonek A, Levey E, McHale K, Sponseller P, Saraste H. Associations between orthopaedic findings, ambulation and health-related quality of life in children with myelomeningocele. J Child Orthop. 2008 Feb;2(1):45-54. doi: 10.1007/s11832-007-0069-6. Epub 2007 Dec 15.
PubMed 19308602McCoy AR, Singerman L, Anand N, Kanallakan A. Spina Bifida. Phys Med Rehabil Clin N Am. 2025 Aug;36(3):513-530. doi: 10.1016/j.pmr.2025.03.003. Epub 2025 May 29.
PubMed 40581437
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
- ClinicalTrials.gov ID
- NCT07615686
- Acronym / sponsor ID
- STUDY25100066
- Conditions
- Spina Bifida, Myelomeningocele
- Keywords
- spina bifida, myelomeningocele
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bailey PetersenUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 10 Mar 2028 (estimated)
- Study completion
- 10 Mar 2029 (estimated)
- First posted
- 29 May 2026 (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 single-center, open-label, investigational pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele.
Detailed description
Transcutaneous, or non-invasive, spinal cord stimulation (tSCS) has been effective at improving motor control, especially walking, in adults with a variety of neuromuscular disorders and in children with spinal cord injury. Children with spina bifida often have similar difficulties with walking, muscle strength and bladder control throughout their lives, with few effective therapies to reliably improve walking. In this pilot, the investigators will test if tSCS can improve motor deficits and bladder control in children with spina bifida. The investigators are enrolling up to 20 subjects with myelomeningocele, ages 4-17 years old, that have some difficulty walking but can walk for even short distances with assistance, and that have bladder dysfunction with a stable bladder regimen. Over 4-6 weeks, children will have stimulation using non-invasive tSCS electrodes placed on their low back. Similar protocols have been used for tSCS in children with spinal cord injury and children with cerebral palsy. All previous tSCS studies have shown that this is a safe technology for use with pediatric populations. This pilot study will be used to refine the design of future randomized controlled trials to test tSCS over standard physical therapy care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous SCS | Experimental | Device: Transcutaneous stimulatorAll participants will be receiving transcutaneous spinal cord stimulation |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed myelomeningocele confirmed by a neurosurgeon or neurologist
- Some difficulty ambulating, but able to ambulate at least a short distance (10 meters) with devices and/or assistance.
- Between the ages of 4 and 17 years of age.
- Documented neurogenic bladder dysfunction
- On a stable bladder management regimen at least 4-6 weeks prior to the enrollment in the trial
Key exclusion criteria (6 listed)
- Severe behavioral or cognitive impairments that preclude participation in the study, in the opinion of the investigator.
- Has an active surgery planned for impairments from spina bifida (e.g. tethered cord syndrome surgery or orthopedic surgery) or has had surgery in the last 6 months.
- Is pregnant. Pregnancy will be assessed via verbal report.
- Open wounds at the thoracic or lumbar spine that precludes transcutaneous stimulation.
- Implanted or attached electronic device in any location of the body (e.g. pacemakers, baclofen pumps, or implanted insulin pumps)
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 stimulatoran off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit) | Device | Transcutaneous SCS |
Primary outcome
Muscle Strength
Time frame: 4-6 weeks
change in isometric torque of quadriceps during knee extension
Gait Kinematics
Time frame: 4-6 weeks
Change in joint angles in tSCS vs no stim conditions
Bladder capacity
Time frame: 4-6 weeks
Change in cystometric bladder capacity with tSCS vs no stim conditions
Gait Kinetics
Time frame: 4-6 weeks
Changes in ground reaction forces with and without stimulation
Bladder Pressure
Time frame: 4-6 weeks
Change in voiding pressure with tSCS vs no stim conditions
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 15 Sep 2026.
- Background: PubMed 34615867Keller A, Singh G, Sommerfeld JH, King M, Parikh P, Ugiliweneza B, D'Amico J, Gerasimenko Y, Behrman AL. Noninvasive spinal stimulation safely enables upright posture in children with spinal cord injury. Nat Commun. 2021 Oct 6;12(1):5850. doi: 10.1038/s41467-021-26026-z.
- Background: PubMed 40723009Amirova L, Keller A, Singh G, King M, Parikh P, Stepp N, Ugiliweneza B, Gerasimenko Y, Behrman AL. Cumulative Transcutaneous Spinal Stimulation with Locomotor Training Safely Improves Trunk Control in Children with Spinal Cord Injury: Pilot Study. Children (Basel). 2025 Jun 21;12(7):817. doi: 10.3390/children12070817.
- Background: PubMed 39334648Neighbors E, Brunn L, Casamento-Moran A, Martin R. Transcutaneous Spinal Cord Stimulation Enables Recovery of Walking in Children with Acute Flaccid Myelitis. Children (Basel). 2024 Sep 12;11(9):1116. doi: 10.3390/children11091116.
- Background: PubMed 36198701Hastings S, Zhong H, Feinstein R, Zelczer G, Mitrovich C, Gad P, Edgerton VR. A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy. Nat Commun. 2022 Oct 5;13(1):5660. doi: 10.1038/s41467-022-33208-w.
- Background: PubMed 19308602Danielsson AJ, Bartonek A, Levey E, McHale K, Sponseller P, Saraste H. Associations between orthopaedic findings, ambulation and health-related quality of life in children with myelomeningocele. J Child Orthop. 2008 Feb;2(1):45-54. doi: 10.1007/s11832-007-0069-6. Epub 2007 Dec 15.
- Background: PubMed 40581437McCoy AR, Singerman L, Anand N, Kanallakan A. Spina Bifida. Phys Med Rehabil Clin N Am. 2025 Aug;36(3):513-530. doi: 10.1016/j.pmr.2025.03.003. Epub 2025 May 29.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial may be shared with other researchers for the purpose of data analysis and collaboration.
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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.
Bailey Petersen, PhD principal investigator
University of Pittsburgh
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 stimulator in people with Spina Bifida and Myelomeningocele, run by Bailey Petersen 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 5 inclusion and 6 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 15 Sep 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 Sydney Bader, MS (412-648-4196, syb17@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: 4-6 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?
On the ClinicalTrials.gov record for NCT07615686, which also lists 6 linked publications.
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 15 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.