Health TrialsbyHealthPanel

tSCS in Children With Spina Bifida

ConditionsSpina BifidaMyelomeningocele
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorBailey Petersen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcutaneous stimulator

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Transcutaneous SCSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Muscle Strength

change in isometric torque of quadriceps during knee extension

Time frame
4-6 weeks
2

Gait Kinematics

Change in joint angles in tSCS vs no stim conditions

Time frame
4-6 weeks
3

Bladder capacity

Change in cystometric bladder capacity with tSCS vs no stim conditions

Time frame
4-6 weeks
4

Gait Kinetics

Changes in ground reaction forces with and without stimulation

Time frame
4-6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bailey Petersen

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov
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