Understanding Perinatal Spinal Cord Injury

NCT06808035 | Enrolling By Invitation FDA Device

• 1 other identifier: 23.0722
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (14)

• Supine Functional Neurophysiological Assessment (FNPA)

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

• Acoustic Startle Response (ASR)

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

• Somatosensory Evoked Potentials (SSEP)

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

• Stand/Step Functional Neurophysiological Assessment (FNPA)

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

• Upper Extremity Motor Control Assessment

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

Study Arms (1)

Cervical Perinatal SCI

EXPERIMENTAL

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

Interventions

Activity-Based Recovery Training OTHER

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

Cervical Perinatal SCI

Transcutaneous Spinal Cord Stimulation DEVICE

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

Cervical Perinatal SCI

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Vanderbilt University: collaborator
• University of Leeds: collaborator
• Kentucky Spinal Cord and Head Injury Research Trust: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: February 5, 2025
• Study Start: January 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)