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Coordinated Reset spinal cord stimulation for Neuropathic Pain
Study Summary
This trial is designed to study whether a new spinal cord stimulation paradigm, called Coordinate Reset (CR) Stimulation, can provide better pain relief with reduced energy requirements when compared to conventional stimulation. This study will also look at whether there are changes in brain function associated with effective CR stimulation.
- Neuropathic Pain
- Back Surgery Syndrome
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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Who is running the clinical trial?
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- You have severe pain with a score of 6 or more on a scale used to measure pain levels. You have tried conventional SCS (a type of electrical stimulation therapy) and it has reduced your pain by at least 50%.You have long-term nerve pain in your legs but not in your back, and you are currently receiving or considering spinal cord stimulation treatment.You have a history of seizures that occur without any specific cause or trigger, and happen repeatedly.You are currently taking medication to prevent blood clots.You currently abuse drugs or alcohol according to the person in charge of the study.You have severe mental health issues, including depression that is not related to the study.
- Group 1: Coordinated Reset- Spinal Cord 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
How many individuals have registered to participate in the research?
"Correct. According to clinicaltrials.gov, this medical study is currently accepting new participants; the trial was first posted on July 12th 2021 and its details were most recently updated on July 25th 2022. The research requires 10 volunteers from a single site."
Are individuals below the age of 25 permitted to partake in this experiment?
"According to the stipulated criteria, this trial is accepting participants between 22 and 70 years of age."
Are there still opportunities for individuals to become part of this research endeavor?
"Affirmative. According to the data available on clinicaltrials.gov, this medical experiment is still accepting participants since its original posting date of July 12th 2021 and subsequent update on July 25th 2022. 10 volunteers are required from one location for enrollment in the trial."
Could I potentially be a candidate for this medical examination?
"This clinical trial seeks 10 individuals between the ages of 22 and 70 who are currently suffering from failed back surgery syndrome. Furthermore, they must be able to fluently communicate in English, have chronic neuropathic lower extremity pain but no back pain, have had conventional spinal cord stimulation (SCS) for at least 3 months before beginning the study, demonstrate pronounced pain with a VAS score of 6 or higher that responds well to SCS treatment indicated by a 50% reduction on their VAS scale."
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