Understanding Perinatal Spinal Cord Injury
ConditionPerinatal Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorUniversity of Louisville
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Activity-Based Recovery Training
Other interventionABRT 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 Stimulation
DeviceTranscutaneous 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Cervical Perinatal SCIExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Louisville
Lead sponsor
Vanderbilt University
Collaborator
University of Leeds
Collaborator
Kentucky Spinal Cord and Head Injury Research Board
Collaborator
Source ClinicalTrials.gov