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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05163899

Collaborator

(none)

Enrollment

Location

Arms

35.4

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tethered Cord Tethered Cord Syndrome Occult Spina Bifida Spina Bifida Occulta	Procedure: Release of filum terminale	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

For a surgical vs non-surgical trial, the investigator can not be masked thus only the evaluators will be unaware of the arm.

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 19, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surgery Filum release	Procedure: Release of filum terminale Surgery will be offered to section the filum terminale Other Names: Laminectomy for tethered cord release
No Intervention: Observation Medical Management only

Arm

Intervention/Treatment

Active Comparator: Surgery

Filum release

Procedure: Release of filum terminale

Surgery will be offered to section the filum terminale

Other Names:

Laminectomy for tethered cord release

No Intervention: Observation

Medical Management only

Outcome Measures

Primary Outcome Measures

Change in symptoms related to tethered cord, as measured by the OCCULT Scale [Baseline, 1 year]
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.

Secondary Outcome Measures

Change in urologic incontinence score [Baseline, 1 year]
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.
Change in fecal incontinence score [Baseline, 1 year]
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.
Number of patients who cross over [1 year]
Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery [1 year]
For patients who presented with urological symptoms
Number of intra-operative findings that are discordant with MRI interpretations [Intraoperative]
To examine whether there is a limitation in MRI in identifying pathology that is identified at the time of surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.