tSCS in Children 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 stimulator.
- Who it may be relevant to
- Registry conditions: Spina Bifida, Myelomeningocele. Basic parameters: 4 years — 17 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 →
Unsure about the terms? Read our patient guide →
Official title
Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida
Overview
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.
Interventions
- Device Transcutaneous stimulator
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
Primary outcome measures
- Muscle Strength [Time frame: 4-6 weeks]
- Gait Kinematics [Time frame: 4-6 weeks]
- Bladder capacity [Time frame: 4-6 weeks]
- Gait Kinetics [Time frame: 4-6 weeks]
- Bladder Pressure [Time frame: 4-6 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
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. PMID 34615867
- Amirova 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. PMID 40723009
- Neighbors 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. PMID 39334648
- Hastings 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. PMID 36198701
- Danielsson 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. PMID 19308602
- McCoy 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. PMID 40581437
Identifiers
NCT: NCT07615686 · STUDY25100066