Recruiting

Surgical Sectioning

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05163899

Conditions

Tethered Cord

Tethered Cord Syndrome

Occult Spina Bifida

Spina Bifida Occulta

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Interventions

Release of filum terminale

Study Details

Brief 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.

Conditions

Tethered Cord

Tethered Cord Syndrome

Occult Spina Bifida

Spina Bifida Occulta

Study ID

NCT05163899

Start date

May 19, 2022

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Surgery

Filum release

no intervention: Observation

Medical Management only

Interventions

Release of filum terminale

Surgery will be offered to section the filum terminale

Primary outcome measure

  • Change in symptoms related to tethered cord, as measured by the OCCULT Scale [ Time Frame: Baseline, 1 year ]

Central Contacts and Locations

Central contacts

Cynthia Nguyen

(212) 746-1788cyn4002@med.cornell.edu

Jeffrey Greenfield, MD, PhD

(212) 746-2363jpgreenf@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Jeffrey Greenfield, MD, PhD

212-746-2363jpgreenf@med.cornell.edu

Cynthia Nguyen, MsCR

212-746-1788cyn4002@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • tethered cord
  • occult
  • filum terminale
  • tight filum

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-05-14.