Noninvasive Spinal Stimulation for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve hand function in children with spinal cord injuries using a technique called transcutaneous spinal cord stimulation (scTS). Researchers are testing the optimal location and intensity for applying scTS, either on the neck or lower back, and evaluating whether combining it with activity-based upper extremity training is more effective than training alone. Children who have had a spinal cord injury for over six months and retain some finger movement might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their hand function through innovative techniques.
What prior data suggests that transcutaneous spinal cord stimulation is safe for children with spinal cord injuries?
Research has shown that transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy is generally safe for individuals with spinal cord injuries. Studies have found that most participants tolerate this combination well. In one study, 72% of participants experienced improvements in strength and hand function without major side effects. Another study confirmed that using tSCS with therapy is safe and practical for enhancing upper limb movement. These findings suggest that the treatment is also safe for children with spinal cord injuries, as it has been well-tolerated in similar groups.12345
Why are researchers excited about this trial?
Researchers are excited about noninvasive spinal stimulation for spinal cord injury because it offers a novel way to enhance recovery in affected individuals. Unlike traditional therapies that focus solely on physical rehabilitation, this approach combines activity-based upper extremity training with spinal cord transcutaneous stimulation (scTS), which may boost the nervous system's response to therapy. This method is unique because it intermittently applies electrical stimulation during training, potentially leading to improved motor function more effectively than physical therapy alone. While current treatments primarily involve physical therapy and surgery, the integration of scTS could represent a significant advancement in promoting neural recovery and functional improvements.
What evidence suggests that this trial's treatments could be effective for improving hand function in children with spinal cord injuries?
This trial will compare the effects of activity-based upper extremity training with and without transcutaneous spinal cord stimulation (scTS) for individuals with spinal cord injuries. Studies have shown that combining scTS with activity-based training can improve hand and arm function. In one study, 72% of participants experienced better hand function with this combination. Research suggests that attending more than 60 sessions of scTS along with activity-based therapy can lead to significant recovery. This combined approach appears effective because scTS may enhance nerve function, aiding movement recovery. Early findings indicate that using both methods together is more effective than activity training alone.56789
Who Is on the Research Team?
Goutam Singh, PhD
Principal Investigator
University of Louisville and Spalding University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Clinical and experimental assessments to categorize injury severity and assess hand function
Treatment
Activity-based upper extremity training with and without spinal cord stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Activity based upper extremity training
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Activity-based upper extremity training (AB-UET + scTS) will be administered 5d/week and 1 hour 30 minutes/session. UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of \~ 10 minute/bouts.
Activity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
The Craig H. Neilsen Foundation
Collaborator
Citations
Combining Spinal Cord Transcutaneous Stimulation with ...
This study offered the preliminary efficacy of combining scTS and ABT to facilitate UE function recovery following cervical SCI.
Upper Extremity Training for Chronic Cervical Spinal Cord ...
This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve ...
Enhancing upper limb recovery with a combined activity ...
Recent advances suggest that combining ABT with transcutaneous spinal cord stimulation (tSCS) may further enhance motor recovery in individuals with cervical ...
Combined Activity‐Based Therapy and Cervical Spinal ...
Combined activity-based therapy and cervical spinal cord stimulation for the restoration of upper limb function after cervical spinal cord ...
Activity-based recovery training with spinal cord epidural ...
Activity-based recovery training with spinal cord epidural stimulation improves standing performance in cervical spinal cord injury. Research ...
Safety and Effectiveness of Multisite Transcutaneous ...
Objective: Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based ...
Feasibility of combined activity-based therapy and ...
Preliminary results suggest that early intervention combining ABT and tSCS is feasible, well tolerated and safe for upper limb rehabilitation in subacute SCI ...
Activity-Based Therapy and Transcutaneous Spinal Cord ...
The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand ...
Systematic Review of Activity-Based Interventions to ...
This systematic review examined the literature to see if there is evidence to suggest that activity-based interventions can lead to neural recovery after SCI.
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