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

Who is this study for? Patients with Tethered Cord Syndrome, Occult Spina Bifida
What treatments are being studied? Release of Filum Terminale
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Macie Tendrich, RN
mat9275@med.cornell.edu
(212) 746-2363
Backup
Jeffrey Greenfield, MD, PhD
jpgreenf@med.cornell.edu
(212) 746-2363
Time Frame
Start Date: 2022-05-19
Estimated Completion Date: 2028-05
Participants
Target number of participants: 20
Treatments
Active_comparator: Surgery
Filum release
No_intervention: Observation
Medical Management only
Authors
Marissa Michael
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov

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