What side effects are associated with this type of intervention?

The most common treatment for Tethered Cord Syndrome (TCS) is the surgical release of the filum terminale. Known side effects of this procedure include potential infection, cerebrospinal fluid leaks, and nerve damage, which can lead to weakness or sensory changes. Additionally, there may be risks of spinal instability and postoperative pain. While these side effects are generally rare, they are important considerations for patients and healthcare providers when deciding on the best treatment approach.

What prior FDA approvals exist?

The surgical release of the filum terminale is a treatment option for Tethered Cord Syndrome (TCS) that aims to alleviate tension on the spinal cord. This procedure is hypothesized to provide symptomatic relief for patients with Occult Tethered Cord Syndrome (OTCS). There is no specific mention of FDA-approved drugs or treatments for TCS in the provided context. The focus remains on the surgical intervention rather than pharmacologic treatments.

What other types of research exist?

Promising novel alternatives to surgical release of the filum terminale for Tethered Cord Syndrome patients include: 1) Minimally invasive spinal cord untethering techniques, which aim to reduce recovery time and complications associated with traditional surgery. 2) Advanced neurostimulation therapies, such as percutaneous electrical nerve stimulation, which may help alleviate symptoms by modulating nerve activity. 3) Investigational pharmacological agents targeting the underlying pathophysiology of TCS, potentially offering symptom relief without the need for invasive procedures. Patients should discuss these options with their healthcare provider to determine the best course of action based on their specific condition and overall health.

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Procedure

Surgical Sectioning for Tethered Cord Syndrome (OCCULT Trial)

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: SurgeryActive Control1 Intervention

Filum release

Group II: ObservationActive Control1 Intervention

Medical Management only

0 / 4Eligibility criteria met

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.