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Procedure

Surgical Sectioning for Tethered Cord Syndrome (OCCULT Trial)

Phase 2
Recruiting
Led By Jeffrey Greenfield, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ≥ 2 and < 80 years of age
Refractory to medical management of symptoms for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

OCCULT Trial Summary

This trial is testing whether cutting a strand of tissue at the end of the spinal cord is a more effective treatment forsymptoms than current medical management, and whether the risks are outweighed by the potential benefits.

Who is the study for?
This trial is for people aged 2 to 79 with Occult Tethered Cord Syndrome (OTCS) who haven't improved after at least a year of medical treatment. They must score at least 30 on the OCCULT Grading Scale. It's not for those with visible signs of spinal issues, previous lumbar spine or spinal dysraphism surgeries, or a history of central nervous system infections or autoimmune diseases.Check my eligibility
What is being tested?
The study tests if cutting the filum terminale—a fibrous tissue at the end of the spinal cord—is better than standard medical care in relieving symptoms of OTCS. The hypothesis suggests surgery could be more effective and that benefits may outweigh risks.See study design
What are the potential side effects?
Potential side effects are not detailed here but generally can include pain, infection risk from surgery, possible neurological changes due to manipulation near the spinal cord, and complications related to anesthesia.

OCCULT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 79 years old.
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My symptoms have not improved with treatment for over a year.
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You have a total score of at least 30 on the OCCULT Grading Scale, which measures a type of skin condition.

OCCULT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in symptoms related to tethered cord, as measured by the OCCULT Scale
Secondary outcome measures
Change in fecal incontinence score
Change in urologic incontinence score
Number of intra-operative findings that are discordant with MRI interpretations
+2 more

OCCULT Trial Design

2Treatment groups
Active Control
Group I: SurgeryActive Control1 Intervention
Filum release
Group II: ObservationActive Control1 Intervention
Medical Management only

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,852 Total Patients Enrolled
Jeffrey Greenfield, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Release of filum terminale (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05163899 — Phase 2
Tethered Cord Syndrome Research Study Groups: Surgery, Observation
Tethered Cord Syndrome Clinical Trial 2023: Release of filum terminale Highlights & Side Effects. Trial Name: NCT05163899 — Phase 2
Release of filum terminale (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163899 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study seeking volunteers who are aged 60 and above?

"Patients aged 2 to 80 are eligible for recruitment into this trial, in accordance with the stated criteria."

Answered by AI

How many participants are involved in this clinical experiment?

"Affirmative, according to clinicaltrials.gov this study is actively searching for volunteers enrolled in it. The trial was initially posted on May 19th 2022 and the latest update took place July 15th of the same year. 1 site will be recruiting a total of 20 individuals into the experiment."

Answered by AI

What potential hazards should patients be aware of before undergoing a surgical procedure?

"There is limited evidence on the safety of surgery, so it got a score of 2."

Answered by AI

Who is eligible to join this medical research?

"Those hoping to take part in this clinical trial should have tethered cord syndrome and be within the ages of 2 and 80. A total of 20 participants are required for this study."

Answered by AI

Are there any vacancies for volunteers in this research endeavor?

"Correct. According to clinicaltrials.gov, this trial is currently recruiting participants, which began on the 19th of May 2022 and was last edited 15 July 2022. This study seeks 20 patients from a single site location."

Answered by AI

Who else is applying?

What site did they apply to?
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby May 2024