Biomarker Study in Patients With Trigeminal Neuralgia

Not Applicable

Recruiting

• Conditions: Trigeminal Neuralgia
• Interventions: Procedure: trigminal nerve block with RFT

• Registration Number: NCT05685797
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-17
• Study Start: 2023-01-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TN patients with intervention	trigminal nerve block with RFT	Patients with TN receiving 2 times of trigeminal nerve block and radiofrequency thermocoagulation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes of numerical rating scale changes during 3 time period	Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation	numerical rating scale changes during 3 time period

Trial Locations

Locations (1)

Hong ji HEE; 🇰🇷 Daegu, Korea, Republic of