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Spinal Cord Stimulation for Spinal Muscular Atrophy (SCSinSMA Trial)
SCSinSMA Trial Summary
This trial will test if a pain treatment can also improve motor function in people with spinal muscular atrophy.
SCSinSMA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSCSinSMA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SCSinSMA Trial Design
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Who is running the clinical trial?
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- You have a condition in your spine that makes it impossible to implant the lead, as decided by the study neurosurgeon.I am currently pregnant or breastfeeding.You have a specific kind of spinal muscular atrophy (SMA) that started after you were 18 months old or after you learned to walk. You are between 16 and 65 years old, can stand independently for at least 3 seconds, have a certain score on a test, and are willing to attend study visits and follow study instructions.I have been diagnosed with 5q-SMA based on a genetic test.Your spinal canal is not big enough for the study neurosurgeon to put in the lead.You have a serious fear of being in small, enclosed spaces.I am taking or need medication for blood clots, muscle spasms, or seizures during the study.I have severe joint stiffness that limits my movement.You have a medical implant that prevents you from having a magnetic resonance imaging (MRI) scan.
- Group 1: 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
Does this experiment extend to elderly individuals aged 85 or above?
"The age requirement for this clinical trial is between 16 to 64. Seperately, 47 trials are available for minors and 151 studies exist that target adults aged 65 or older."
Am I eligible to enroll in this medical experiment?
"To be eligible for this study, individuals must have visual atrophy and be between 16 to 64 years of age. The trial has a maximum capacity of 10 participants."
Are there any openings available for participants in this trial?
"Affirmative. According to details posted on clinicaltrials.gov, the current recruitment drive for this trial began back in April 5th 2022 and was most recently edited on July 11th 2022. 10 volunteers are sought from 1 medical facility."
How many individuals have been included in the clinical trial thus far?
"Affirmative. Clinicaltrials.gov verifies that this medical experiment was posted on April 5th, 2022 and is actively searching for participants. The study desires 10 patients from 1 centre to partake in the trail."
What are the aims of this research endeavor?
"During the course of this 29 day clinical trial, researchers will measure Muscle Weakness as their primary outcome. Secondary outcomes include Motor Function RHS (Revised Hammersmith Functional Scale), Sensorimotor Network Function (measured through brain/spinal cord functional Magnetic Resonance Imaging [fMRI]), and Cortico-spinal Tract Integrity (assessed via Transcranial magnetic stimulation evoked potentials). Meaningful Change is defined as a ≥2 point improvement when comparing SCS-on and SCS-off results."
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