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

Primary Purpose

Tethered Cord, Tethered Cord Syndrome, Occult Spina Bifida

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Release of filum terminale
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tethered Cord focused on measuring tethered cord, occult, filum terminale, tight filum

Eligibility Criteria

2 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Surgery

Observation

Arm Description

Filum release

Medical Management only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of patients who cross over
Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery
For patients who presented with urological symptoms
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

Full Information

First Posted
November 8, 2021
Last Updated
July 27, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05163899
Brief Title
Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tethered Cord, Tethered Cord Syndrome, Occult Spina Bifida, Spina Bifida Occulta
Keywords
tethered cord, occult, filum terminale, tight filum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Filum release
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Medical Management only
Intervention Type
Procedure
Intervention Name(s)
Release of filum terminale
Other Intervention Name(s)
Laminectomy for tethered cord release
Intervention Description
Surgery will be offered to section the filum terminale
Primary Outcome Measure Information:
Title
Change in symptoms related to tethered cord, as measured by the OCCULT Scale
Description
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.
Time Frame
Baseline, 1 year
Secondary Outcome Measure Information:
Title
Change in urologic incontinence score
Description
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.
Time Frame
Baseline, 1 year
Title
Change in fecal incontinence score
Description
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.
Time Frame
Baseline, 1 year
Title
Number of patients who cross over
Time Frame
1 year
Title
Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery
Description
For patients who presented with urological symptoms
Time Frame
1 year
Title
Number of intra-operative findings that are discordant with MRI interpretations
Description
To examine whether there is a limitation in MRI in identifying pathology that is identified at the time of surgery
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Macie Tendrich, RN
Phone
(212) 746-2363
Email
mat9275@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Greenfield, MD, PhD
Phone
(212) 746-2363
Email
jpgreenf@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Greenfield, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Greenfield, MD, PhD
Phone
212-746-2363
Email
jpgreenf@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Amanda Cruz, PA
Phone
212-746-2363
Email
aac9031@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Marissa Michael, BS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34268593
Citation
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.
Results Reference
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Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients

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