Surgery for treating Occult Tethered Cord Syndrome
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
This study is testing if surgery to release a tight cord in the spine can help people with Occult Tethered Cord Syndrome feel better compared to just using medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 80 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05163899 on ClinicalTrials.gov |
What this trial studies
This phase II pilot trial investigates whether surgical release of the filum terminale is more effective than medical management for patients with Occult Tethered Cord Syndrome (OTCS). Participants will be randomly assigned to either undergo surgery or receive medical management, with their symptoms and any adverse events monitored for one year. After this period, those in the medical management group may switch to the surgical group if deemed beneficial. The study aims to determine the safety and efficacy of surgical intervention in alleviating symptoms associated with OTCS.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 2 to 80 who have not responded to medical management for at least one year and have documented OTCS.
Not a fit: Patients with radiographically identified tethered cord or those with a history of certain spinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant symptomatic relief for patients suffering from Occult Tethered Cord Syndrome.
How similar studies have performed: While the approach of surgical intervention for OTCS is being explored, similar studies have shown promising results in related conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Greenfield, MD, PhD — Weill Medical College of Cornell University
- Study coordinator: Macie Tendrich, RN
- Email: mat9275@med.cornell.edu
- Phone: (212) 746-2363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.