🔎 Trials Near Me

Home › Spinal Cord Injuries › NCT05163899

Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients

Recruiting

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

Sponsor: Weill Medical College of Cornell University · Participants: 20 · Started: May 19, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05163899

Locations in the U.S.

New YorkWeill 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.