Understanding Perinatal Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Activity-Based Recovery Training, Transcutaneous Spinal Cord Stimulation.
- Who it may be relevant to
- Registry conditions: Perinatal Spinal Cord Injury. Basic parameters: 3 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions
Overview
The purpose of this study is to deepen our understanding of children who have a cervical spinal cord injury obtained in utero or at birth and examine the effects of tailored activity-based recovery training (ABRT) in combination with transcutaneous spinal cord stimulation (scTS). This is a within subjects, pre-post design study. Neurophysiological, sensorimotor, and autonomic assessments will occur pre, interim, and post 40 sessions of ABRT in conjunction with scTs.
Detailed description
Infants who suffer perinatal spinal cord injuries (SCI) are injured during a critical period of neurological development. Confounded further by on-going development, they are particularly vulnerable to the consequences of SCI (e.g., paralysis and paresis, hypertonia, bladder/bowel dysfunction, respiratory compromise) on lifelong health, function, and quality of life. There are only 4 published case reports of the presentation and rehabilitation of perinatally injured children. Clinically, children with high cervical SCI compared to those with low level SCI exhibit slow and limited active upper and lower extremity (UE, LE) movements, high tone, and poor trunk control. Children with low cervical lesions have a more typical pattern of loss below the injury level. We intend to expand our understanding of the scope of perinatal SCI and its impact in order to address integrated, whole-body system rehabilitation.
The overall objective of this study is to deepen our understanding of pediatric perinatal cervical SCIs and then formulate tailored treatment strategies that encourage neuroplasticity, enhance functional capacity, and improve the overall quality of life of children. The results from this study will provide pilot data and evidence that we can comprehensively assess and develop a therapeutic roadmap to improve whole-body function in children with perinatal SCI.
This is a pilot, within subjects, repeated measures, pre-post design.
Aim 1: Investigate the impact of perinatal, cervical SCI comparing high (C2-3) and low (C4-6) injuries on a whole-body profile of health: neurophysiological, sensorimotor, autonomic.
Aim 2: In children with perinatal SCIs, investigate the effect of 40 sessions of tailored transcutaneous spinal stimulation (scTS) paired with activity-based restorative therapies (ABRTs) on neurophysiological profile (spinal pathway functional integrity) and sensorimotor function.
Aim 3: In children with chronic, cervical, perinatal SCIs, investigate the effect of 40 sessions of scTS paired with ABRT on autonomic functions, i.e., respiratory, blood pressure regulation, bladder/bowel.
Interventions
- Other Activity-Based Recovery Training
ABRT uses task-specific training to improve neuromuscular capacity. ABRT will be tailored to participant presentation. Activity-Based Locomotor Training consists of stepping, standing, and sitting activities on a body weight support (BWS) treadmill using a harness and while overground. Therapists and trainers provide hands-on assistance for safety and kinematics. BWS is varied during sessions with a goal of optimal kinematics at the lowest BWS. Activities performed standing will focus on alignme - Device Transcutaneous Spinal Cord Stimulation
Transcutaneous Spinal Cord Stimulation (scTs) is a non-invasive stimulation administered over the skin using a modulated biphasic or monophasic waveform at 15-90Hz and a carrier frequency of 5-10kHz. Bouts of scTs at the cervical, thoracic, lumbar, and/or coccygeal level will be administered midline or just lateral to the spinous processes during activity-based recovery training.
Primary outcome measures
- Participant Specific Outcome Measures [Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
Secondary outcome measures (12)
- Supine Functional Neurophysiological Assessment (FNPA) [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Acoustic Startle Response (ASR) [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Somatosensory Evoked Potentials (SSEP) [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Stand/Step Functional Neurophysiological Assessment (FNPA) [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Upper Extremity Motor Control Assessment [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Trunk Motor Control Assessment [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Segmental Assessment of Trunk Control [Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
- Pediatric Neuromuscular Recovery Scale (NRS) [Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
- Spasticity of upper extremity and lower extremity [Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)]
- Respiratory Motor Control Assessment (RMCA) [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Bowel Questionnaire [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
- Overground Walking Assessment of Gait [Time frame: At study enrollment and following 40 sessions (approximately 2 months)]
Eligibility criteria
Inclusion criteria
- diagnosed with a perinatal (injured in utero or at birth), upper motor neuron spinal cord injury involving cervical spinal levels
- discharged from inpatient hospitalization/inpatient rehabilitation
Exclusion criteria
- Botox use within the past 3 months
- Current oral baclofen or baclofen pump use
- Musculoskeletal impairment limiting range of motion (e.g. severe scoliosis), unhealed fracture, or other medical impairment limiting study participation
- History of allodynia (heightened skin sensitivity typically at the level of the lesion site)
- History of scoliosis surgery
- Ventilator-dependence
- Unwillingness to wean from daytime use of thoroco/lumbosacral orthosis and ankle/foot orthosis during the intervention period
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Louisville — Louisville
Identifiers
NCT: NCT06808035 · 23.0722