~1 spots leftby Jul 2025

Non-invasive Spinal Stimulation for Spinal Cord Injury

AL
Overseen byAndrea L Behrman, PT, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Louisville
No Placebo Group

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.

Research Team

AL

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

I have been discharged from in-patient rehab.
I struggle with sitting up straight or reaching without losing my balance.
I have had an upper body nerve injury for over a year.
See 1 more

Exclusion Criteria

I have a physical condition that limits my movement or an unhealed fracture.
My spinal cord injury is due to Spina Bifida.
I am currently taking oral baclofen and cannot or do not want to stop under a doctor's advice.
See 4 more

Treatment Details

Interventions

  • Biostim-5/Neostim transcutaneous spinal stimulator (Device)
Trial OverviewThe study tests if combining locomotor training with non-invasive spinal stimulation can help improve sitting posture and trunk control in kids with long-term spinal cord injuries. It will involve 12 participants who haven't tried this method before.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Transcutaneous spinal stimulationExperimental Treatment1 Intervention
Participants with chronic SCI will receive 60 sessions of activity based-locomotor training (AB-LT) combined with transcutaneous stimulation (scTS).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

The Craig H. Neilsen Foundation

Collaborator

Trials
62
Recruited
3,100+

Ray Neilsen

The Craig H. Neilsen Foundation

Chief Executive Officer since 2006

MBA and JD from the University of Utah

Dr. Steven Kirshblum

The Craig H. Neilsen Foundation

Chief Medical Officer since 2022

MD