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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05163899
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Release of filum terminale — PROCEDURE
    Surgery will be offered to section the filum terminale

Study Details

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.

Key Dates

Start date
May 19, 2022
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgery
    Filum release
  • No Intervention: Observation
    Medical Management only

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Jeffrey Greenfield, MD, PhD
[email protected]
212-746-2363
Cynthia Nguyen, MsCR
[email protected]
212-746-1788
Marissa Michael, MD (SUB_INVESTIGATOR)

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Weill Cornell Medicine· New York, NY