An interventional study of Activity-Based Recovery Training and Transcutaneous Spinal Cord Stimulation in Perinatal Spinal Cord Injury, sponsored by University of Louisville. Recruiting at 1 site in United States. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Louisville · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 6 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
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Exclusion Criteria:
Participants with high cervical and low cervical SCI will perform tailored ABRT+scTS. Pre, interim, and post assessments of neurophysiological, sensorimotor, and autonomic function will be compared within-subjects and between high and low cervical SCI groups. Participants will come for daily activity-based recovery training (ABRT) + transcutaneous spinal stimulation (scTS). ABRT+scTS will take place 5 days per week for approximately 2.5 hours each (1.5 hours of lower extremity training and 1 hour of upper extremity training) for a total of 40 sessions consisting of facilitated sitting, standing, stepping, and UE motor tasks such as grasping, reaching, and hand manipulations.
Other: Activity-Based Recovery Training · Device: Transcutaneous Spinal Cord Stimulation
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.
Also known as: Activity-Based Training, Activity-Based Locomotor Training, Activity-Based Upper Extremity Training, ABRT, ABT, AB-LT, AB-UET
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.
Also known as: scTS, TcStim
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)
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.
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Upper Extremity Motor Control Assessment
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) scores, Box and Block Test (BBT( number of blocks), transer BBT time (tBBT), hand grip force, pinch force
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Trunk Motor Control Assessment
Averaged electromyography RMS values of the trunk muscles, trunk posture (angles)
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Segmental Assessment of Trunk Control
Score between 1-20 indicating the level of appropriate static, active, and reactive control of the trunk and level of support described.
Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
Pediatric Neuromuscular Recovery Scale (NRS)
Overall and individual task NRS scores. Units of 1A-4C
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
Number of cycles elicited in response to the pendulum drop-test
Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
Respiratory Motor Control Assessment (RMCA)
Lung volume, maximum inspiratory pressure, maximum expiratory pressure, and peak cough flow will be reported.
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Bowel Questionnaire
Total Neurogenic Bowel Dysfunction (NBD) score and interpretation of impairment: 0-6 Very Minor, 7-9 Minor, 10-13 Moderate, 14+ Severe neurogenic bowel dysfunction.
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Overground Walking Assessment of Gait
1. Observational Gait Scale (OGS) Tool - score out of 22 2. Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) Category Scores
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Bladder Questionnaire
A change in lower urinary tract function within the study timeframe per variable from an impaired state to recovery will be reported, specifically: Awareness of need to empty the bladder, bladder emptying methods, average number of voluntary bladder emptying, involuntary urine leakage, a change in medication, surgical procedures.
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Gross Motor Function Measure-88 (GMFM-88)
88 tasks across 5 dimensions: 1. lying/rolling, 2) sitting, 3) crawling/kneeling, 4) standing, 5) walking/running/jumping. Individual item scores (0-3, not tested (NT), dimension percentage, and overall percentage will be reported.
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Plan to share: Yes — IPD of demographics and primary and secondary outcomes measures will be shared via Open Data Commons for Spinal Cord Injury.
Time frame: IPD will be made available beginning 1 year after publication with no end date.
Access criteria: Authorized users who have acquired an OCD account will have access to IPD.
Data sharing details ↗ · odc-sci.org
Started Jan 2024 (actual). Primary completion is estimated for Jan 2027, 36 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 36 months is close to that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
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