Understanding Perinatal Spinal Cord Injury

N/AEnrolling By InvitationNCT06808035

University of Louisville6 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Perinatal Spinal Cord Injury

Interventions

Activity-Based Recovery TrainingOTHER

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 alignment incorporating static, active, and dynamic tasks. Activities performed during overground are based on neuromuscular capacity and appropriate developmental and functional levels. Principles of ABRT will be shared with parents/caregivers to foster activity in the home and community. Activity-Based Upper Extremity Training uses task-specific training of the trunk and upper extremities administered in sitting or standing via manual facilitation or support in a stander for best posture.

Transcutaneous Spinal Cord StimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Participant Specific Outcome Measures

Participant specific outcomes measures will be identified at study initiation via parent interview. Parents will identify daily, functional tasks that the participant has difficulty or challenges performing at a practical, successful level. Functional tasks performed by the participant will be video recorded at study initiation, post-20 sessions, and post-40 intervention sessions. Metrics of task performance include success or failure of the task.

Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)

Secondary Outcomes

Supine Functional Neurophysiological Assessment (FNPA)

1\) Averaged electromyography (EMG) root mean square (RMS) values above and below the level of the lesion. 2) EMG isolated to limb performing the task and proximal stabilizers (yes, no). If no, identify location (limbs/trunk) of auxiliary EMG activity, 3) Timing of response

Time frame: At study enrollment and following 40 sessions (approximately 2 months)

Acoustic Startle Response (ASR)

Percent of responses above (blink) and below the level of the lesion.

Time frame: At study enrollment and following 40 sessions (approximately 2 months)

Somatosensory Evoked Potentials (SSEP)

1. Presence of response in the brain from stimulation of tibial and median nerves in the periphery, below and above the spinal cord lesion. 2. If response is present, latency of responses (mseconds) from initiation of stimulation and across the lesion.

Time frame: At study enrollment and following 40 sessions (approximately 2 months)

Stand/Step Functional Neurophysiological Assessment (FNPA)

Test completed in children who are non-ambulatory. 1\) Can child initiate a step in the treadmill environment with body weight support? From parallel stance: Yes or No. From stride stance: Yes or No. if yes, hip range of motion (degrees) during swing.

Data from ClinicalTrials.gov

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