Non-invasive Spinal Stimulation for Spinal Cord Injury
Trial Summary
What is the purpose of this trial?
This trial tests a combination of exercises and electrical stimulation to improve sitting and trunk control in children with severe spinal injuries. It targets children aged 3-12 who cannot walk due to their injuries. The treatment aims to strengthen muscles and activate nerves to improve posture and control.
Will I have to stop taking my current medications?
If you are currently using oral baclofen, you will need to stop taking it and wean off under medical guidance to participate in the trial.
What data supports the effectiveness of the treatment Biostim-5/Neostim transcutaneous spinal stimulator for spinal cord injury?
Is non-invasive spinal stimulation generally safe for humans?
Research on spinal cord stimulation, including cervical spinal cord stimulation (cSCS), shows it is generally safe with low rates of complications. For example, a study found a 0.5% rate of spinal cord injury and no deaths among 2053 cases. Another study on cSCS for aneurysmal subarachnoid hemorrhage patients reported no complications or long-term side effects during a one-year follow-up.678910
How does non-invasive spinal stimulation differ from other treatments for spinal cord injury?
Non-invasive spinal stimulation is unique because it uses surface electrodes to stimulate the spinal cord without surgery, targeting both ventral and dorsal nerve roots to activate spared neural circuits. This approach is different from traditional methods like epidural stimulation, which requires surgical implantation, and it offers a safer, more accessible option for patients.25111213
Research Team
Andrea L Behrman, PT, PhD
Principal Investigator
University of Louisville
Eligibility Criteria
This trial is for children aged 3-12 with chronic spinal cord injuries at T10 or above, who are not able to walk and have moderate to severe trunk control issues. They should be new to both activity-based locomotor training and transcutaneous spinal stimulation, and must have been out of in-patient rehab for over a year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments for clinical and biomechanical outcomes
Treatment
Participants receive 60 sessions of activity-based locomotor training combined with transcutaneous spinal stimulation
Post-Treatment Assessment
Participants are assessed for changes in trunk control and posture after completing the treatment sessions
Follow-up
Participants are monitored for the durability of training effects and responsiveness of clinical outcome measures
Treatment Details
Interventions
- Biostim-5/Neostim transcutaneous spinal stimulator
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
The Craig H. Neilsen Foundation
Collaborator