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NCT Number: NCT07615686

tSCS 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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Sydney Bader, MS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous stimulator

Device

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

Primary outcomes

  1. Muscle Strength

    Time frame: 4-6 weeks

    change in isometric torque of quadriceps during knee extension

  2. Gait Kinematics

    Time frame: 4-6 weeks

    Change in joint angles in tSCS vs no stim conditions

  3. Bladder capacity

    Time frame: 4-6 weeks

    Change in cystometric bladder capacity with tSCS vs no stim conditions

  4. Gait Kinetics

    Time frame: 4-6 weeks

    Changes in ground reaction forces with and without stimulation

  5. Bladder Pressure

    Time frame: 4-6 weeks

    Change in voiding pressure with tSCS vs no stim conditions

Study contacts

Contact information is provided by the study sponsor or research team.

Sydney Bader, MS

CONTACT

[email protected]

412-648-4196

Sponsors and collaborators

Lead sponsor

Bailey Petersen

Other

Registry information

Official study title

Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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