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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
Summary
This trial is testing whether a surgery to cut a small piece of tissue at the end of the spinal cord is better than standard medical treatments for patients with Occult Tethered Cord Syndrome (OTCS). These patients often do not find relief from typical treatments. The surgery aims to relieve pressure and tension in the spinal cord, which may help improve their symptoms. This surgical method is currently the most widely accepted treatment for OTCS.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 79 years old.
Select...
My symptoms have not improved with treatment for over a year.
Select...
You have a total score of at least 30 on the OCCULT Grading Scale, which measures a type of skin condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in symptoms related to tethered cord, as measured by the OCCULT Scale
Secondary study objectives
Change in fecal incontinence score
Change in urologic incontinence score
Number of intra-operative findings that are discordant with MRI interpretations
+2 moreTrial Design
2Treatment groups
Active Control
Group I: SurgeryActive Control1 Intervention
Filum release
Group II: ObservationActive Control1 Intervention
Medical Management only
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The surgical release of the filum terminale, a common treatment for Tethered Cord Syndrome (TCS), involves cutting the fibrous tissue at the end of the spinal cord to alleviate tension. This is important for TCS patients because the tension can cause significant neurological symptoms, including pain, weakness, and bladder dysfunction.
By releasing this tension, the surgery aims to relieve these symptoms and prevent further neurological deterioration, offering symptomatic relief and long-term stabilization.
Tethered cord syndrome in adults.
Tethered cord syndrome in adults.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,078 Previous Clinical Trials
1,137,790 Total Patients Enrolled
Jeffrey Greenfield, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a total score of at least 30 on the OCCULT Grading Scale, which measures a type of skin condition.I am between 2 and 79 years old.I have a history of spinal cord issues related to Meningocele or Myelomeningocele.I have had surgery on my lower back before.I have visible skin markings indicating a dermal sinus tract.I am between 2 and 80 years old.My symptoms have not improved with treatment for over a year.I have had surgery for spinal dysraphism.You have a condition called tethered cord that can be seen on a special type of picture.I have had an infection or autoimmune disease affecting my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery
- Group 2: Observation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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