Biomarker Study in Patients With Trigeminal Neuralgia

Inflammatory Cytokine and Neuropeptide Study in Patients With Trigeminal Neuralgia

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).

Study Overview

• Status: Recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: trigminal nerve block with RFT

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sung W Jung; Phone Number: 01021064343; Email: swon12@daum.net
• Study Contact Backup: Name: Ji H Hong; Phone Number: 01046794343; Email: swon13@daum.net

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Recruiting
    • Hong ji HEE
    • Contact: J Hee Hong; Phone Number: 82-53-258-7767; Email: swon13@daum.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cytokine; neurotransmitter; trigeminal neuralgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: 2022-09-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No