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

Tethered Cord Syndrome Clinical Trial

— OCCULT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163899
• Other study ID #: 20-06022262
• Status: Recruiting
• Phase: Phase 2
• Start date: May 19, 2022
• Est. completion date: May 2025

Study information

• Verified date: July 2023
• Source: Weill Medical College of Cornell University
• Contact: Macie Tendrich, RN
• Phone: (212) 746-2363
• Email: mat9275[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism
• Syndrome
• Tethered Cord
• Tethered Cord Syndrome

Intervention

Procedure:
• Release of filum terminale
Surgery will be offered to section the filum terminale

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Michael MM, Garton ALA, Kuzan-Fischer CM, Uribe-Cardenas R, Greenfield JP. A critical analysis of surgery for occult tethered cord syndrome. Childs Nerv Syst. 2021 Oct;37(10):3003-3011. doi: 10.1007/s00381-021-05287-5. Epub 2021 Jul 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptoms related to tethered cord, as measured by the OCCULT Scale	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.	Baseline, 1 year
Secondary	Change in urologic incontinence score	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.	Baseline, 1 year
Secondary	Change in fecal incontinence score	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.	Baseline, 1 year
Secondary	Number of patients who cross over		1 year
Secondary	Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery	For patients who presented with urological symptoms	1 year
Secondary	Number of intra-operative findings that are discordant with MRI interpretations	To examine whether there is a limitation in MRI in identifying pathology that is identified at the time of surgery	Intraoperative