tSCS in Children With Spina Bifida

NCT07615686 | Recruiting FDA Device

• 1 other identifier: STUDY25100066
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spina Bifida; Myelomeningocele

Keywords

spina bifida; myelomeningocele

Outcome Measures

Primary Outcomes (5)

• Muscle Strength

  change in isometric torque of quadriceps during knee extension

  4-6 weeks

• Gait Kinematics

  Change in joint angles in tSCS vs no stim conditions

  4-6 weeks

• Bladder capacity

  Change in cystometric bladder capacity with tSCS vs no stim conditions

  4-6 weeks

• Gait Kinetics

  Changes in ground reaction forces with and without stimulation

  4-6 weeks

• Bladder Pressure

  Change in voiding pressure with tSCS vs no stim conditions

  4-6 weeks

Study Arms (1)

Transcutaneous SCS

EXPERIMENTAL

All participants will be receiving transcutaneous spinal cord stimulation

Device: Transcutaneous stimulator

Interventions

Transcutaneous stimulator DEVICE

an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)

Transcutaneous SCS

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bailey Petersen: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bailey Petersen, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Bader, MS

CONTACT

412-648-4196; syb17@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): March 10, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the end of the trial upon publication of the first manuscript.
• Access Criteria: Data must be directly requested to the PI and will be shared upon completion of necessary data sharing agreement to protect confidential patient information.

Locations

US (1)