tSCS in Children With Spina Bifida
Purpose
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
Eligibility
- Eligible Ages
- Between 4 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Transcutaneous SCS |
All participants will be receiving transcutaneous spinal cord stimulation |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Bailey Petersen
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.