Perinatal Spinal Cord InjuryNCT06808035
Understanding Perinatal Spinal Cord Injury
A study testing Activity-Based Recovery Training and Transcutaneous Spinal Cord Stimulation in people with Perinatal Spinal Cord Injury, run by University of Louisville at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Perinatal Spinal Cord Injury
- What is being tested?
- Activity-Based Recovery Training and Transcutaneous Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Lisa R. Clayton, CCRP, 502-569-7996, kidskickparalysis@louisville.edu
Andrea L. Behrman, PhD, PT
About this study
Official title: Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions
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.
Read the 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.
- Conditions
- Perinatal Spinal Cord Injury
- Being tested
- Activity-Based Recovery Training, Transcutaneous Spinal Cord Stimulation
- Keywords
- Spinal Cord Injury, Activity-Based Recovery Training, Perinatal-Onset, Transcutaneous Spinal Cord Stimulation, Whole-Systems, Pediatric Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity-Based Recovery TrainingOther
Also called Activity-Based Training, Activity-Based Locomotor Training, Activity-Based Upper Extremity Training, ABRT
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
Also called scTS, TcStim
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Activity-Based Recovery Training; Device: Transcutaneous Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
Secondary outcomes (14)
Supine Functional Neurophysiological Assessment (FNPA)
- 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
Measured: 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.
Measured: At study enrollment and following 40 sessions (approximately 2 months)
Somatosensory Evoked Potentials (SSEP)
- Presence of response in the brain from stimulation of tibial and median nerves in the periphery, below and above the spinal cord lesion.
- If response is present, latency of responses (mseconds) from initiation of stimulation and across the lesion.
Measured: At study enrollment and following 40 sessions (approximately 2 months)
Stand/Step Functional Neurophysiological Assessment (FNPA)
Test completed in children who are non-ambulatory.
- 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At study enrollment and following 40 sessions (approximately 2 months)
Overground Walking Assessment of Gait
- Observational Gait Scale (OGS) Tool - score out of 22
- Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) Category Scores
Measured: 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.
Measured: 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.
Measured: At study enrollment and following 40 sessions (approximately 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start9 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, University of Leeds, Kentucky Spinal Cord and Head Injury Research Board
- Responsible party
- Principal investigator, Andrea L. Behrman, PhD, PT, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808035
- Sponsor's protocol ID
- 23.0722
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD of demographics and primary and secondary outcomes measures will be shared via Open Data Commons for Spinal Cord Injury.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions
- ClinicalTrials.gov ID
- NCT06808035
- Acronym / sponsor ID
- 23.0722
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Vanderbilt University, University of Leeds, Kentucky Spinal Cord and Head Injury Research Board
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Perinatal SCI | Experimental | Other: Activity-Based Recovery Training, Device: Transcutaneous Spinal Cord StimulationParticipants 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity-Based Recovery TrainingAlso: Activity-Based Training, Activity-Based Locomotor Training, Activity-Based Upper Extremity Training, ABRTABRT 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. | Other | Cervical Perinatal SCI |
| Transcutaneous Spinal Cord StimulationAlso: scTS, TcStimTranscutaneous 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. | Device | Cervical Perinatal SCI |
Primary outcome
Participant Specific Outcome Measures
Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
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.
14 secondary outcomes
Supine Functional Neurophysiological Assessment (FNPA)
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Acoustic Startle Response (ASR)
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Somatosensory Evoked Potentials (SSEP)
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Stand/Step Functional Neurophysiological Assessment (FNPA)
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Upper Extremity Motor Control Assessment
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Trunk Motor Control Assessment
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Segmental Assessment of Trunk Control
Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
Pediatric Neuromuscular Recovery Scale (NRS)
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
Time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)
Respiratory Motor Control Assessment (RMCA)
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Bowel Questionnaire
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Overground Walking Assessment of Gait
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Bladder Questionnaire
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Gross Motor Function Measure-88 (GMFM-88)
Time frame: At study enrollment and following 40 sessions (approximately 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD of demographics and primary and secondary outcomes measures will be shared via Open Data Commons for Spinal Cord Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity-Based Recovery Training and Transcutaneous Spinal Cord Stimulation in people with Perinatal Spinal Cord Injury, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa R. Clayton, CCRP (502-569-7996, kidskickparalysis@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Specific Outcome Measures (time frame: At study enrollment, following 20 sessions (approximately 1 month), and following 40 sessions (approximately 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.