Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06918119
Status
Recruiting
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Conditions

  • Myelomeningocele
  • Spina Bifida

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous stimulation — DEVICE
    DS8R (Digitimer LLC) for transcutaneous neurostimulation.

Study Details

A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.

Key Dates

Start date
Aug 7, 2025
Status verified
Oct 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Functional motor training with transcutaneous spinal cord stimulation
    Transcutaneous spinal cord stimulation will be delivered to the skin over the lower thoracic and lumbar spine region using adhesive electrodes for ages 5-11 for one multi-hour visit. The effects of stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
  • Experimental: Extended functional motor training with transcutaneous spinal cord stimulation
    An extended functional training arm for a subset of 10 subjects, ages 12-18, in which they will receive up to twelve multi-hour sessions of a therapeutic neuromuscular strengthening intervention within a 6 week period.

Primary Outcome Measure

Manual muscle testing (MMT) [ Time Frame: 1 to 12 visits (up to 6 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Kristin D Zhao, Ph.D
[email protected]
507-284-8942

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Mayo Clinic in Rochester· Rochester, MN

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