Clinical trial NCT05685797: Biomarker Study in Patients With Trigeminal Neuralgia
Official title: Inflammatory Cytokine and Neuropeptide Study in Patients With Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: trigeminal neuralgia
cytokine
neurotransmitter
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum level of inflammatory cytokine changes during 3 time period
timeFrame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
measure: serum level of neurotransmitter changes during 3 time period
timeFrame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
Secondary outcomes:
measure: Changes of numerical rating scale changes during 3 time period
timeFrame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
References: