Study 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.
- Tethered Cord Syndrome
- Spina Bifida Occulta
- Occult Spina Bifida
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 1 year
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Surgery
1 of 2
Observation
1 of 2
Active Control
20 Total Participants · 2 Treatment Groups
Primary Treatment: Surgery · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 2 - 80 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Michael, Marissa M., Andrew L. A. Garton, Claudia M. Kuzan-Fischer, Rafael Uribe-Cardenas, and Jeffrey P. Greenfield. 2021. “A Critical Analysis of Surgery for Occult Tethered Cord Syndrome”. Child's Nervous System. Springer Science and Business Media LLC. doi:10.1007/s00381-021-05287-5.
- Michael MM, Garton ALA, Kuzan-Fischer CM, Uribe-Cardenas R, Greenfield JP. A critical analysis of surgery for occult tethered cord syndrome. Childs Nerv Syst. 2021 Oct;37(10):3003-3011. doi: 10.1007/s00381-021-05287-5. Epub 2021 Jul 15.
- 2022. "Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05163899.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor