Biomarker Study in Patients With Trigeminal Neuralgia

Study Overview
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Brief Summary
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Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with primary trigeminal neuralgia (TN).

Detailed Description
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Sudden and electrick shooting sensation of face is an important clinical feature of trigeminal neuralgia (TN). The severe and excruciating nature of pain intensity associated with TN can impair the physical and psychosocial well-being of the patient, however, pathophysiologic mechanism of TN still remains unclear. Recentrly, there have been a few studies suggesting biomarker levels in the blood and CSF level, however, further study is required to elucidate the action mechanism. Up to 90% of patients can achieve pain reduction using medical therapy alone. However, 10% -15% of TN cases demonstrate a minimal response to medication with various side effects. Radiofrequency thermocoagulation (RFT) of the trigeminal ganglion is an alternative treatment option for patients who are poor candidates for microvascular decompression or show serious side effects to medication. Recent study revealed that RFT of the trigeminal ganglion resulted in Barrow Neurological Institute (BNI) pain scale I or II in 71.7% of patients, with a median time to recurrence of 36 months. Although patients experience significant pain relief after RFT, it is uncertain whether inflammatory cytokine and neurocytokine (CGRP, substance P, VIP) are reduced.

Official Title
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Inflammatory Cytokine and Neuropeptide Study in Patients With Trigeminal Neuralgia

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Procedure: trigminal nerve block with RFT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TN patients with NRS more than 4 TN patients who failed medical treatment TN patients showing severe adverse reaction with medication Exclusion Criteria: Patients showing allergic reaction to local anesthetics Patients with coagulation abnormality

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TN patients with intervention<br>Patients with TN receiving 2 times of trigeminal nerve block and radiofrequency thermocoagulation | Procedure: trigminal nerve block with RFT<br>* trigminal nerve block with RFT<br>|
| No Intervention: Control group<br>Healthy volunteer without any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of inflammatory cytokine changes during 3 time period | inflammatory cytokine including Tumor necrosis factor-alpha, Interleukin-6 changes during 3 time period Higher score means worse outcome | Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation | 
| serum level of neurotransmitter changes during 3 time period | neurotransmitter including Calcitonene gene related peptide, substance P, vasoactive intestitinal polypeptide changes during 3 time period Higher score means worse outcome | Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of numerical rating scale changes during 3 time period | numerical rating scale changes during 3 time period | Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trigeminal neuralgia, cytokine, neurotransmitter