Tethered CordOCCULTNCT05163899
Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
A study testing Release of filum terminale in people with Tethered Cord and Tethered Cord Syndrome, run by Weill Medical College of Cornell University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Tethered Cord, Tethered Cord Syndrome, Occult Spina Bifida
- What is being tested?
- Release of filum terminale
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Jeffrey Greenfield, MD, PhD, 212-746-2363, jpgreenf@med.cornell.edu
Cynthia Nguyen, MsCR, 212-746-1788, cyn4002@med.cornell.edu
About this study
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
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.
Read the 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.
- Being tested
- Release of filum terminale
- Keywords
- tethered cord, occult, filum terminale, tight filum
- Medical subject headings
- Spinal Cord Injuries, Neural Tube Defects, Spina Bifida Occulta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Release of filum terminaleProcedure or surgery
Also called Laminectomy for tethered cord release
Surgery will be offered to section the filum terminale
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | Filum release Receives: Procedure: Release of filum terminale |
| Observation | No intervention | Medical Management only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 year
Secondary outcomes (5)
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.
Measured: Baseline, 1 year
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.
Measured: Baseline, 1 year
Number of patients who cross over
Measured: 1 year
Percent of patients with a decrease in anticholinergic medications at 1 year post-surgery
For patients who presented with urological symptoms
Measured: 1 year
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
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start19 May 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tethered CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Greenfield, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163899
- Sponsor's protocol ID
- 20-06022262
- Acronym
- OCCULT
- Status last verified
- May 2026
- First submitted
- 8 Nov 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34268593