Consorcio Hospital General Universitario de Valencia
Valencia, 46015, Spain
NCT Number: NCT07046247
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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Notify Me18 year and older
All sexes
Observational
Valencia, 46015, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Microvascular decompression for trigeminal neuralgia comparing two different forms to apply the Teflon implant
Time frame: 5 years
The Modified Rankin Scale (mRS) will be used to evaluate neurological disability, ranging from 0 (no symptoms) to 6 (death)
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)
University of Valencia
Other
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
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