Surgery for treating Occult Tethered Cord Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II pilot trial investigates whether surgical release of the filum terminale is more effective than medical management for patients with Occult Tethered Cord Syndrome (OTCS). Participants will be randomly assigned to either undergo surgery or receive medical management, with their symptoms and any adverse events monitored for one year. After this period, those in the medical management group may switch to the surgical group if deemed beneficial. The study aims to determine the safety and efficacy of surgical intervention in alleviating symptoms associated with OTCS.

Why it matters

Who can join: the full rules

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.

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jeffrey Greenfield, MD, PhD — Weill Medical College of Cornell University
• Study coordinator: Cynthia Nguyen
• Email: cyn4002@med.cornell.edu
• Phone: (212) 746-1788

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.