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

Last updated: May 21, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

2

Condition

Holoprosencephaly

Treatment

Release of filum terminale

Clinical Study ID

NCT05163899
20-06022262
  • Ages 2-80
  • All Genders

Study 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 Criteria

Inclusion

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 followingscale:

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

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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Release of filum terminale
Phase: 2
Study Start date:
May 19, 2022
Estimated Completion Date:
May 31, 2028

Study Description

This is a phase II pilot randomized-controlled, single-site trial to determine if surgical untethering of the filum terminale is more effective, preliminarily, than medical management as a treatment option for OTCS. Subjects will be randomized to one of two arms: surgical untethering or medical management only. Symptom improvement and adverse events will be assessed and recorded for 1 year from initiation of treatment. After a minimum of 1 year, subjects who were randomized to the medical management arm may cross over to the surgical arm if the PI deems it is in the subject's best interest to do so. The exploratory hypothesis is that surgery for OTCS is both safe and more effective than medical management at relieving the symptoms of OTCS.

Connect with a study center

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

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