Understanding perinatal spinal cord injury and how targeted therapy may help
Official title: Understanding Perinatal Spinal Cord Injury: Comprehensive Assessment and Personalized Neuromodulation for Improved Whole-Body Functions
Run by University of Louisville · NCT06808035 · Data updated 2026-11-12
This study tests whether tailored activity-based recovery training plus noninvasive spinal stimulation can improve function in children who had a spinal cord injury at birth or before birth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 8 Years |
| Sex | All |
| Enrollment | 6 (estimated) |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Status | Recruiting |
| Started | January 9, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT06808035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants or children with upper motor neuron cervical spinal cord injury that occurred in utero or at birth, who have been discharged from inpatient care and can participate in a structured rehab program.
✕Probably not a fit
Patients with non-cervical injuries, ongoing ventilator dependence, or medical conditions preventing participation in intensive therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot, within-subject study enrolls children with perinatal cervical spinal cord injuries to receive a sequence of activity-based recovery training combined with transcutaneous spinal cord stimulation. Participants are assessed before, during, and after 40 training sessions to track neurophysiological, sensorimotor, and autonomic changes. The goal is to understand how this combined approach could promote neuroplasticity and improve whole-body function and quality of life. It is conducted as a pre-post design across a small, developing pediatric population, with careful monitoring and safety measures. Lead institutions include the University of Louisville and collaborators from Vanderbilt, University of Leeds, and the Kentucky Spinal Cord and Head Injury Research Board.
Why it matters
Potential benefit: If successful, the approach could enhance motor function and daily living activities for children with perinatal cervical SCI.
How similar studies have gone: There have been only a few published case reports; this represents a novel, piloting approach in this specific population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Louisville
Louisville, Kentucky, United States Recruiting
Study contacts
- Study coordinator: Lisa R. Clayton, CCRP
- Email: kidskickparalysis@louisville.edu
- Phone: 502-569-7996
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Non-invasive spinal cord stimulation to improve blood pressure control after spinal cord injury
We will test whether non-invasive spinal cord stimulation can help adults with chronic spinal cord injuries at or above T1 who have troublesome low or unstable blood pressure.
-
Dome-only coiling for severe aneurysmal subarachnoid hemorrhage
This will test a minimally invasive dome-protection coiling procedure to prevent re-bleeding in adults who have had a severe aneurysmal subarachnoid hemorrhage.
-
Betadine versus sterile water for cleaning the urethra before straight catheter placement
This study will test whether cleaning the urethra with sterile water or Betadine changes urine bacteria and how much discomfort adults feel when they get an in‑office straight catheter.
-
No perioperative dexamethasone for brain metastasis surgery
This trial will try skipping perioperative dexamethasone in adults having surgery for newly diagnosed brain metastases to see if it is safe and reduces lymphopenia.
-
Reactions to Distress (RED) — Louisville, KY
This study tests whether a brief, culturally-informed mindfulness exercise can reduce threat-focused attention in Black adults who have experienced race-related stress and whether race-related stress increases attention to threat compared with non-race stress.
-
Saline versus balanced crystalloid fluids for moderate-to-severe traumatic brain injury
This will test whether giving saline or a balanced crystalloid fluid to people with moderate-to-severe traumatic brain injury leads to better recovery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.