Biomarker Study in Patients With Trigeminal Neuralgia

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05685797

Collaborator

(none)

Enrollment

Arms

4.1

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Procedure: trigminal nerve block with RFT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Inflammatory Cytokine and Neuropeptide Study in Patients With Trigeminal Neuralgia

Anticipated Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Keimyung University Dongsan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center

ClinicalTrials.gov Identifier:

NCT05685797

Other Study ID Numbers:

2022-09-016

First Posted:

Jan 17, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center

trigeminal neuralgia

cytokine

neurotransmitter

Additional relevant MeSH terms:

Trigeminal Neuralgia

Neuralgia

Study Results

No Results Posted as of Jan 31, 2023