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Transcutaneous vs Epidural Spinal Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Rajiv Saigal, MD, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a spinal cord injury at least one-year duration
Are willing and able to have surgical implantation of the epidural stimulator for the treatment of pain according to the study timeline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-11 months
Awards & highlights
Study Summary
This trial will compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function in people with incomplete spinal cord injuries.
Who is the study for?
This trial is for adults aged 21-70 with a spinal cord injury of at least one year who experience chronic pain and have difficulty with leg functions. They must be able to attend regular therapy sessions, have social support, and agree to potential surgical implantation of an epidural stimulator. Exclusions include those with certain neuropathies, cardiovascular issues, implanted devices, substance abuse problems, severe osteoporosis or mental health conditions.Check my eligibility
What is being tested?
The study compares two types of electrical stimulation treatments for improving leg function in people with incomplete spinal cord injuries: transcutaneous (through the skin) and epidural (with surgically implanted electrodes). It aims to see which method better enables control over weak or paralyzed muscles.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, risk associated with surgical implantation for the epidural group such as infection or bleeding, possible muscle fatigue from increased use during therapy sessions, and skin irritation from surface electrodes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a spinal cord injury for at least one year.
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I agree to have a surgery to implant an epidural stimulator for pain treatment.
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I have trouble with walking and moving around in my daily activities.
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I am between 21 and 70 years old.
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My heart and lung health is stable, and I don't have frequent severe reactions that would stop me from doing leg exercises or tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8-11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-11 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neuromuscular Recovery Scale
Secondary outcome measures
Berg Balance Test
Electromyography recording of LE and trunk muscles
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Comparison of transcutaneous & epidural stimulationExperimental Treatment2 Interventions
Comparison of transcutaneous vs epidural electrical stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous spinal stimulation
2022
N/A
~40
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,932 Total Patients Enrolled
U.S. National Science FoundationFED
34 Previous Clinical Trials
8,868 Total Patients Enrolled
Rajiv Saigal, MD, PhDPrincipal Investigator - University of Washington
Harborview Medical Center, University of Washington Medical Center
Tufts University School Of Medicine (Medical School)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a spinal cord injury for at least one year.My doctor has approved me for walking training.I have nerve damage in my hands or feet.I might have trouble understanding or following the study's procedures.I have a rheumatic disease like rheumatoid arthritis or lupus.I agree to have a surgery to implant an epidural stimulator for pain treatment.I have trouble with walking and moving around in my daily activities.I do not have any unhealed injuries or infections that could affect my ability to participate in leg exercises or tests.I have had surgery on my legs that could affect study results.My cancer is currently active.I have a history of a neurological condition like stroke or MS.I have stiff joints in my legs that don't fully bend or straighten.I can perform simple tasks when asked.I experience chronic pain.I do not have uncontrolled high blood pressure or serious heart, lung, or blood clotting issues.I do not have heart or muscle conditions that stop me from doing physical therapy.I am between 21 and 70 years old.I can attend 3-5 physical therapy sessions weekly for three months.I have been diagnosed with depression or anxiety based on specific questionnaires.I have had fractures due to low-energy incidents before or after a spinal injury.I rely on a ventilator to breathe.You have a medical device implanted in your body that helps stimulate certain parts of your body (like the spine, nerves, heart, or hearing).I can safely participate in all study tests as determined by a doctor.My spinal cord injury is due to an autoimmune disease.My heart and lung health is stable, and I don't have frequent severe reactions that would stop me from doing leg exercises or tests.My bone density test shows a T score of -2.0 or lower in my spine or hip.You have a history of drinking too much alcohol or using drugs excessively.I am being treated for osteoporosis.You may need to have a device implanted in your body to help with stimulation.
Research Study Groups:
This trial has the following groups:- Group 1: Comparison of transcutaneous & epidural 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.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04043715 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this particular research endeavor actively enrolling participants?
"Aye, according to clinicaltrials.gov, this trial is still enrolling patients and has been since August 1st 2019. 6 individuals are required at a single location for the study's completion; lastly it was updated on October 5th 2020."
Answered by AI
For whom is this clinical trial designed to benefit?
"This research is seeking out 6 patients with a neurological affliction that abide by the following criteria: between 21 and 70 years of age, no cardiopulmonary issues or frequent autonomic dysreflexia which would impede participation in lower extremity rehabilitation/testing activities; willing to have an epidural stimulator surgically implanted according to study timeline; capable of performing simple motor tasks while having access to adequate social support to attend assessment sessions ranging from once per week up until 9 months; must possess chronic pain along with difficulty in mobility when it comes to everyday activities (i.e walking, transferring surface-to-surface); eligible for implanted"
Answered by AI
Is this medical study open to participants below the age of majority?
"To qualify for this study, participants must be between 21 and 70 years of age."
Answered by AI
What is the approximate number of participants in this research endeavor?
"Affirmative. Clinicaltrials.gov has information which implies that this clinical research is still searching for volunteers, with the study first posted on August 1st 2019 and most recently updated October 5th 2020. 6 participants are desired from a single medical facility."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
What questions have other patients asked about this trial?
Will this help me walk?
PatientReceived no prior treatments
Why did patients apply to this trial?
I tried different treatments and it didn’t work for me.
PatientReceived 2+ prior treatments
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