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Transcutaneous vs Epidural Spinal Stimulation for Spinal Cord Injury
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Comparison of transcutaneous & epidural stimulation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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"
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."
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."
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