tSCS in Children With Spina Bifida

Официальное название

Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcutaneous stimulator
  an off the shelf TENS unit or Digitimer DS8R (using same parameters as TENS unit)

Первичные конечные точки

• Muscle Strength [Срок оценки: 4-6 weeks]
• Gait Kinematics [Срок оценки: 4-6 weeks]
• Bladder capacity [Срок оценки: 4-6 weeks]
• Gait Kinetics [Срок оценки: 4-6 weeks]
• Bladder Pressure [Срок оценки: 4-6 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Публикации

• Keller A, Singh G, Sommerfeld JH, King M, Parikh P, Ugiliweneza B, D'Amico J, Gerasimenko Y, Behrman AL. Noninvasive spinal stimulation safely enables upright posture in children with spinal cord injury. Nat Commun. 2021 Oct 6;12(1):5850. doi: 10.1038/s41467-021-26026-z. PMID 34615867
• Amirova L, Keller A, Singh G, King M, Parikh P, Stepp N, Ugiliweneza B, Gerasimenko Y, Behrman AL. Cumulative Transcutaneous Spinal Stimulation with Locomotor Training Safely Improves Trunk Control in Children with Spinal Cord Injury: Pilot Study. Children (Basel). 2025 Jun 21;12(7):817. doi: 10.3390/children12070817. PMID 40723009
• Neighbors E, Brunn L, Casamento-Moran A, Martin R. Transcutaneous Spinal Cord Stimulation Enables Recovery of Walking in Children with Acute Flaccid Myelitis. Children (Basel). 2024 Sep 12;11(9):1116. doi: 10.3390/children11091116. PMID 39334648
• Hastings S, Zhong H, Feinstein R, Zelczer G, Mitrovich C, Gad P, Edgerton VR. A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy. Nat Commun. 2022 Oct 5;13(1):5660. doi: 10.1038/s41467-022-33208-w. PMID 36198701
• Danielsson AJ, Bartonek A, Levey E, McHale K, Sponseller P, Saraste H. Associations between orthopaedic findings, ambulation and health-related quality of life in children with myelomeningocele. J Child Orthop. 2008 Feb;2(1):45-54. doi: 10.1007/s11832-007-0069-6. Epub 2007 Dec 15. PMID 19308602
• McCoy AR, Singerman L, Anand N, Kanallakan A. Spina Bifida. Phys Med Rehabil Clin N Am. 2025 Aug;36(3):513-530. doi: 10.1016/j.pmr.2025.03.003. Epub 2025 May 29. PMID 40581437

Идентификаторы

NCT: NCT07615686 · STUDY25100066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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