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Surgical Sectioning for Tethered Cord Syndrome (OCCULT Trial)
OCCULT Trial Summary
This trial is testing whether cutting a strand of tissue at the end of the spinal cord is a more effective treatment forsymptoms than current medical management, and whether the risks are outweighed by the potential benefits.
OCCULT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOCCULT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OCCULT Trial Design
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Who is running the clinical trial?
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- You have a total score of at least 30 on the OCCULT Grading Scale, which measures a type of skin condition.I am between 2 and 79 years old.I have a history of spinal cord issues related to Meningocele or Myelomeningocele.I have had surgery on my lower back before.I have visible skin markings indicating a dermal sinus tract.I am between 2 and 80 years old.My symptoms have not improved with treatment for over a year.I have had surgery for spinal dysraphism.You have a condition called tethered cord that can be seen on a special type of picture.I have had an infection or autoimmune disease affecting my brain or spinal cord.
- Group 1: Surgery
- Group 2: Observation
- 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 the study seeking volunteers who are aged 60 and above?
"Patients aged 2 to 80 are eligible for recruitment into this trial, in accordance with the stated criteria."
How many participants are involved in this clinical experiment?
"Affirmative, according to clinicaltrials.gov this study is actively searching for volunteers enrolled in it. The trial was initially posted on May 19th 2022 and the latest update took place July 15th of the same year. 1 site will be recruiting a total of 20 individuals into the experiment."
What potential hazards should patients be aware of before undergoing a surgical procedure?
"There is limited evidence on the safety of surgery, so it got a score of 2."
Who is eligible to join this medical research?
"Those hoping to take part in this clinical trial should have tethered cord syndrome and be within the ages of 2 and 80. A total of 20 participants are required for this study."
Are there any vacancies for volunteers in this research endeavor?
"Correct. According to clinicaltrials.gov, this trial is currently recruiting participants, which began on the 19th of May 2022 and was last edited 15 July 2022. This study seeks 20 patients from a single site location."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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