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OpenTrials
Completed

NCT Number: NCT07046247

Impact of Teflon Technique on Recurrence After Microvascular Decompression for Trigeminal Neuralgia

The study aims to see if shredded Teflon placed away from the trigeminal nerve is equally effective in pain control in Trigeminal Neuralgia while minimizing the risks of pain recurrence due to granuloma formation when this material is placed immediately close to the nerve in a pledget form.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Consorcio Hospital General Universitario de Valencia

Valencia, 46015, Spain

About this study

Complications associated with Teflon implants in the treatment of Trigeminal Neuralgia have been reported, including granuloma formation and persistent neuroinflammation, which can mimic tumor recurrence or lead to renewed symptoms. These concerns underscore the importance of precise implant positioning and accurate volume control. At the reporting institution, the investigators have consistently used a technique involving minimal amounts of shredded Teflon placed around the offending vessel, positioned at a distance from the trigeminal nerve itself. The goal of this technique is to elicit localized arachnoiditis to stabilize the artery and prevent re-compression. To date, no published studies have directly correlated the amount and form of Teflon used with subsequent inflammation and recurrence, particularly with imaging-based validation. The present study seeks to address this gap by retrospectively analyzing the outcomes of microvascular decompression procedures performed using this specific Teflon application method, correlating clinical outcomes with MRI findings to assess the degree of inflammatory response and the likelihood of symptom recurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Trigeminal Neuralgia refractory to medical therapy and treated via microvascular decompression

Exclusion criteria

  • Other craniofacial neuralgias, atypical facial pain, trigeminal neuralgia (TN) due to non-vascular causes (e.g., multiple sclerosis), and those with posterior fossa pathology, such as tumors, infarctions, hematomas, infections, or inflammatory lesions
  • Patients treated by alternative methods, including percutaneous radiofrequency thermocoagulation, glycerol injection, balloon compression, or radiosurgery

Treatment and study plan

Microvascular decompression for trigeminal neuralgia

Procedure

Microvascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant

Primary outcomes

  1. Modified Ranking scale

    Time frame: 5 years

    The Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)

  2. Barrow Neurological Institute Pain Intensity Scale

    Time frame: 5 years

    The Barrow Neurological Institute (BNI) Pain Intensity Scale will be used to assess pain control, ranging from 1 (no pain, no medication) to 5 (severe pain without relief)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Effect of Teflon Implant on Nerve Tissue and Its Relationship With Recurrences in the Treatment of Trigeminal Neuralgia by Microvascular Decompression, With Special Attention to the Method of Application: A Retrospective Clinical Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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