Myelomeningocele, Spina Bifida
Conditions
Keywords
spina bifida, myelomeningocele
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.
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.
Interventions
DEVICETranscutaneous stimulator
an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)
Sponsors
Bailey Petersen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | 4-6 weeks | change in isometric torque of quadriceps during knee extension |
| Gait Kinematics | 4-6 weeks | Change in joint angles in tSCS vs no stim conditions |
| Bladder capacity | 4-6 weeks | Change in cystometric bladder capacity with tSCS vs no stim conditions |
| Gait Kinetics | 4-6 weeks | Changes in ground reaction forces with and without stimulation |
| Bladder Pressure | 4-6 weeks | Change in voiding pressure with tSCS vs no stim conditions |
Countries
United States
Contacts
CONTACTSydney Bader, MS
PRINCIPAL_INVESTIGATORBailey Petersen, PhD
University of Pittsburgh
Outcome results
None listed