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Spinal Cord Stimulation for Spinal Cord Injury

N/A
Recruiting
Led By Ismael Seanez, PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes before and 30 minutes after intervention; 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers learn more about how electrical stimulation of the spinal cord can improve movement for people with spinal cord injuries.

Who is the study for?
This trial is for individuals aged 16-65 with a traumatic spinal cord injury between C4-T9 levels, classified as ASIA C or D. They should have difficulty moving their legs independently and be at least one year post-injury. Healthy volunteers in the same age range without major health issues can also participate. Exclusions include severe comorbidities, implanted devices like pacemakers, drug use affecting the study, pregnancy, uncontrolled infections or illnesses that could interfere with exercises.
What is being tested?
The study examines how spinal cord stimulation (SCS) affects motor function recovery in people with spinal injuries by assessing changes in neural circuits' excitability and plasticity. It involves electrophysiology assessments of different neural tracts and activity-based training combined with transcutaneous SCS.
What are the potential side effects?
While specific side effects are not listed for this type of intervention, potential risks may include discomfort at the stimulation site, skin irritation from electrodes used during electrophysiology assessments, muscle fatigue due to training activities, and possible exacerbation of existing pain conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes before and 30 minutes after intervention; 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes before and 30 minutes after intervention; 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
F-wave response persistence
Motor evoked potentials amplitude and latency
Reaction time to startle response
Secondary study objectives
Change in movement smoothness
Changes in time to completion from baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Experimental: Non-invasive spinal cord stimulation and strength trainingExperimental Treatment5 Interventions
This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Group II: Experimental: Non-invasive spinal cord stimulation and precision trainingExperimental Treatment5 Interventions
This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Group III: Experimental: Non-invasive spinal cord stimulationExperimental Treatment4 Interventions
This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Group IV: Experimental: Long-term activity-based training with non-invasive spinal cord stimulationExperimental Treatment5 Interventions
This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Group V: Experimental: Activity-based training wtih non-invasive spinal cord stimulationExperimental Treatment5 Interventions
This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Group VI: Experimental: Activity-based trainingExperimental Treatment4 Interventions
This arm will perform 30 minutes of activity-based training using leg movements.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,740 Total Patients Enrolled
Ismael Seanez, PhDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Activity-based training Clinical Trial Eligibility Overview. Trial Name: NCT05472584 — N/A
Spinal Cord Injury Research Study Groups: Experimental: Non-invasive spinal cord stimulation, Experimental: Activity-based training, Experimental: Activity-based training wtih non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation and strength training, Experimental: Non-invasive spinal cord stimulation and precision training, Experimental: Long-term activity-based training with non-invasive spinal cord stimulation
Spinal Cord Injury Clinical Trial 2023: Activity-based training Highlights & Side Effects. Trial Name: NCT05472584 — N/A
Activity-based training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05472584 — N/A
~80 spots leftby Aug 2027
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