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Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
Phase II Pilot Randomized-Controlled Trial for the Investigation of the Preliminary Efficacy of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
Who can join
Ages 2 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Male or female ≥ 2 and \< 80 years of age. * Refractory to medical management of symptoms for at least 1 year. * Documentation of OTCS, as defined by a total score of at least 30 on the following scale: OCCULT Grading Scale (Score 0-100) Orthopedic Abnormality: 0-15; Central Nervous System Dysfunction: 0-25; Cutaneous Stigmata: 0-10; Urological or Bowel Dysfunction: 0-25; Lumbosacral Anatomy: 0-15; Tissue Integrity Disorder: 0-10. Exclusion Criteria: * Subjects \< 2 or \> 80 years of age. * Radiographically identified tethered cord, as defined by any of the following: * A low-lying conus (at or below the L2-3 disc space) * A thickened filum (\>2 mm) * Fat in the filum or lipoma * Distinct adhesion or tethering. * A history of Meningocele manqué or Myelomeningocele. * Cutaneous markings of dermal sinus tract. * History of prior surgery on the lumbar spine. * History of prior surgery for spinal dysraphism. * History of prior infection or autoimmune condition of the central nervous system.
About the study
The investigators hypothesize that surgical release of the filum terminale (strand of fibrous tissue at the end of the spinal cord) is a more efficacious treatment option for symptomatic relief than medical management in subjects with Occult Tethered Cord Syndrome (OTCS) and that the risks do not outweigh the benefit profile.
What is being tested
- Release of filum terminale (procedure)
Sponsor: Weill Medical College of Cornell University · Participants: 20 · Started: May 19, 2022
Contact the study team
- Cynthia Nguyen · Phone: (212) 746-1788
- Jeffrey Greenfield, MD, PhD · Phone: (212) 746-2363
Official record on ClinicalTrials.gov — NCT05163899
Locations in the U.S.
| New York | Weill Cornell Medicine, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.