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

Weill Cornell Medicine (WCM)

Status and phase

Enrolling

Phase 2

Conditions

Occult Spina Bifida

Tethered Cord

Tethered Cord Syndrome

Spina Bifida Occulta

Treatments

Procedure: Release of filum terminale

Study type

Interventional

Funder types

Other

Identifiers

NCT05163899

20-06022262

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

2 to 80 years old

Volunteers

No Healthy Volunteers

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.