RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2022-05-19
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05163899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥ 2 and \< 80 years of age.
  2. * Refractory to medical management of symptoms for at least 1 year.
  3. * Documentation of OTCS, as defined by a total score of at least 30 on the following scale:
  1. * Subjects \< 2 or \> 80 years of age.
  2. * Radiographically identified tethered cord, as defined by any of the following:
  3. * A low-lying conus (at or below the L2-3 disc space)
  4. * A thickened filum (\>2 mm)
  5. * Fat in the filum or lipoma
  6. * Distinct adhesion or tethering.
  7. * A history of Meningocele manqué or Myelomeningocele.
  8. * Cutaneous markings of dermal sinus tract.
  9. * History of prior surgery on the lumbar spine.
  10. * History of prior surgery for spinal dysraphism.
  11. * History of prior infection or autoimmune condition of the central nervous system.

Contacts and Locations

Study Contact

Macie Tendrich, RN
CONTACT
(212) 746-2363
mat9275@med.cornell.edu
Jeffrey Greenfield, MD, PhD
CONTACT
(212) 746-2363
jpgreenf@med.cornell.edu

Principal Investigator

Jeffrey Greenfield, MD, PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Jeffrey Greenfield, MD, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-19
Study Completion Date2026-05

Study Record Updates

Study Start Date2022-05-19
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • tethered cord
  • occult
  • filum terminale
  • tight filum

Additional Relevant MeSH Terms

  • Tethered Cord
  • Tethered Cord Syndrome
  • Occult Spina Bifida
  • Spina Bifida Occulta