Recruiting

Transcutaneous Spinal Cord Stimulation

Sponsor:

Bailey Petersen

Code:

NCT07615686

Conditions

Spina Bifida

Myelomeningocele

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Transcutaneous stimulator

Study Details

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

Study ID

NCT07615686

Start date

Aug 30, 2026

Status verified date

Jul, 2026

Completion date

Mar 10, 2029

Anticipated

Primary completion date

Mar 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Transcutaneous SCS

All participants will be receiving transcutaneous spinal cord stimulation

Interventions

Transcutaneous stimulator

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sydney Bader, MS

412-648-4196syb17@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sydney Bader, MS

syb17@pitt.edu

More Information

Sponsor

Bailey Petersen

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • spina bifida
  • myelomeningocele

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bailey Petersen on 2026-07-31.