Clinical trial NCT06808035: Understanding Perinatal Spinal Cord Injury
Official title: Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Perinatal Spinal Cord Injury
Keywords: Spinal Cord Injury
Activity-Based Recovery Training
Perinatal-Onset
Transcutaneous Spinal Cord Stimulation
Whole-Systems
Pediatric Spinal Cord Injury
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: University of Leeds
name: Kentucky Spinal Cord and Head Injury Research Trust
First posted: 2025-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Participant Specific Outcome Measures
timeFrame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
Secondary outcomes:
measure: Supine Functional Neurophysiological Assessment (FNPA)
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Acoustic Startle Response (ASR)
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Somatosensory Evoked Potentials (SSEP)
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Stand/Step Functional Neurophysiological Assessment (FNPA)
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Upper Extremity Motor Control Assessment
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Trunk Motor Control Assessment
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Segmental Assessment of Trunk Control
timeFrame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
measure: Pediatric Neuromuscular Recovery Scale (NRS)
timeFrame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
measure: Spasticity of upper extremity and lower extremity
timeFrame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
measure: Respiratory Motor Control Assessment (RMCA)
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Bowel Questionnaire
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Overground Walking Assessment of Gait
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Bladder Questionnaire
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: At study enrollment and following 40 sessions (approximately 2 months)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References: