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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes before and 30 minutes after intervention; 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes before and 30 minutes after intervention; 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
F-wave response persistence
Motor evoked potentials amplitude and latency
Reaction time to startle response
Secondary outcome measures
Change in movement smoothness
Changes in time to completion from baseline
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
1,936 Previous Clinical Trials
2,299,570 Total Patients Enrolled
Ismael Seanez, PhDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 16 and 65 years old and do not have any major health issues.I am 16-65 with a spinal injury at C4-T9, can follow commands, and have trouble moving my legs.I struggle to move my legs on my own during daily activities.My spinal cord injury is between my neck and mid-back and is not complete.You have a spinal cord injury.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Non-invasive spinal cord stimulation
- Group 2: Experimental: Activity-based training
- Group 3: Experimental: Activity-based training wtih non-invasive spinal cord stimulation
- Group 4: Experimental: Non-invasive spinal cord stimulation and strength training
- Group 5: Experimental: Non-invasive spinal cord stimulation and precision training
- Group 6: Experimental: Long-term activity-based training with non-invasive spinal cord stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What demographic is best suited to participate in this experiment?
"This trial is attempting to recruit 120 persons, aged 16 to 65 and with prior spinal cord injuries. In order for individuals to be eligible, they must additionally meet the following demands: Healthy Volunteers, Age between 16 and 65 years old, Free of major pathology in any organ system."
Answered by AI
What is the scope of participation for this clinical research?
"Affirmative, the information hosted on clinicaltrials.gov validates that this clinical trial is presently enrolling. The study commenced registration processes on November 1st 2022 and was recently updated on the 22nd of that same month. A total of 120 patients must be admitted at one location for it to commence its trials."
Answered by AI
Is participation in this study restricted to individuals of a certain age bracket?
"This clinical trial seeks to enroll those between the ages of 16 and 65. However, it is worth noting that there are 37 trials exclusively for participants below 18 years of age, as well as 306 other studies dedicated to patients above 65."
Answered by AI
Is this investigation enrolling new participants at present?
"Affirmative. Clinicaltrials.gov demonstrates that the trial, which was initially published on November 1st 2022 is still actively seeking participants. The study plans to recruit 120 patients from a single centre."
Answered by AI
Who else is applying?
What site did they apply to?
Washington University
What portion of applicants met pre-screening criteria?
Met criteria
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