tSCS in Children With Spina Bifida

Bailey Petersen

Status

Enrolling

Conditions

Spina Bifida

Myelomeningocele

Treatments

Device: Transcutaneous stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT07615686

STUDY25100066

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

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.