Biomarker Study in Patients With Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

Inflammatory Cytokine and Neuropeptide Study in Patients With Trigeminal Neuralgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685797
• Other study ID #: 2022-09-016
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2023
• Source: Keimyung University Dongsan Medical Center
• Contact: Ji H Hong
• Phone: 01046794343
• Email: swon13[@]daum.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• trigminal nerve block with RFT
trigminal nerve block with RFT

Locations

Country	Name	City	State
Korea, Republic of	Hong ji HEE	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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