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RecruitingPhase 2NCT05163899

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

Sponsor

Weill Medical College of Cornell University

Enrollment

20 participants

Start Date

May 19, 2022

Study Type

INTERVENTIONAL

Conditions

Tethered CordTethered Cord SyndromeOccult Spina BifidaSpina Bifida Occulta

Summary

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.

Eligibility

Min Age: 2 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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.

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Interventions

PROCEDURERelease of filum terminale

Surgery will be offered to section the filum terminale

Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT05163899