Non-invasive spinal stimulation to improve arm function in children with spinal cord injuries
Transcutaneous Spinal Stimulation Promoting Recovery of Hand and Arm Function After Pediatric-onset Spinal Cord Injury
This study is testing a new way to use spinal stimulation to help children with spinal cord injuries improve their arm and hand movements so they can do everyday activities more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT04032990 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the safety, comfort, and practicality of transcutaneous spinal stimulation (TcStim) in children with cervical spinal cord injuries. The therapy is designed to stimulate the spinal cord to activate arm and hand muscles, enabling children to practice essential movements like grasping and reaching. By combining TcStim with task-specific training, the study seeks to enhance upper limb function and improve the quality of life for affected children. The long-term goal is to provide effective therapies that allow children to engage in daily activities and play more independently.
Who should consider this trial
Good fit: Ideal candidates are children with chronic cervical spinal cord injuries who have moderate to severe upper extremity deficits.
Not a fit: Patients with congenital spinal cord injuries or those who are totally dependent on a ventilator may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance the ability of children with spinal cord injuries to use their arms and hands for everyday tasks.
How similar studies have performed: Previous studies have shown promising results with transcutaneous spinal stimulation in adults and children with other conditions, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * history of chronic, acquired SCI, (\>1 year since injury); * SCI involves cervical and/or high thoracic (T1) levels * moderate to severe upper extremity deficit as assessed by the Pediatric Neuromuscular Recovery Upper Extremity Scale (scores less than 4A out of a 12 point range from 1A-4C on upper extremity tasks, e.g. including inability to fully reach overhead, grasp, or pinch without compensation) * discharged from in-patient rehabilitation Exclusion Criteria: * botox use within past 3 months; * current baclofen use * unhealed upper extremity fracture * any other medical complication limiting participation in the assessments and/or activity- based upper extremity training; * congenital SCI * total ventilator dependence
Where this trial is running
Louisville, Kentucky
- Department of Neurosurgery — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Andrea L Behrman, PT, PhD — University of Louisville
- Study coordinator: Lisa Clayton, B.S.
- Email: Lisa.Clayton@louisville.edu
- Phone: 502-333-8152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.