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NCT Number: NCT05163899

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

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.

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Key information

Conditions

Tethered Cord Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects Occult Spina Bifida Spina Bifida Occulta Spinal Cord Diseases Spinal Cord Injuries Spinal Dysraphism Tethered Cord Syndrome Trauma, Nervous System Wounds and Injuries

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Release of filum terminale

Procedure

Surgery will be offered to section the filum terminale

Other names: Laminectomy for tethered cord release

Primary outcomes

  1. Change in symptoms related to tethered cord, as measured by the OCCULT Scale

    Time frame: Baseline, 1 year

    Combination of neurologic, urologic, orthopedic, and cutaneous assessments. The OCCULT Scale is from 0-100, with 0 being none of the listed signs/symptoms present and 100 being all listed signs/symptoms present with maximum severity.

Secondary outcomes

  1. Change in urologic incontinence score

    Time frame: Baseline, 1 year

    Score is measured by the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form. The minimum score is 0 and the maximum score is 21. The higher the score, the more severe the urinary incontinence symptoms and/or effect of symptoms on quality of life.

  2. Change in fecal incontinence score

    Time frame: Baseline, 1 year

    Score is measured by the Rapid Assessment Faecal Incontinence Score. The minimum score is 0 and the maximum score is 20. The higher the score, the more severe the fecal incontinence symptoms and/or effect of symptoms on quality of life.

  3. Number of patients who cross over

    Time frame: 1 year

  4. Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery

    Time frame: 1 year

    For patients who presented with urological symptoms

  5. Number of intra-operative findings that are discordant with MRI interpretations

    Time frame: Intraoperative

    To examine whether there is a limitation in MRI in identifying pathology that is identified at the time of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Nguyen

CONTACT

[email protected]

(212) 746-1788

Jeffrey Greenfield, MD, PhD

CONTACT

[email protected]

(212) 746-2363

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Acronym: OCCULT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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