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Biomarker Study in Patients With Trigeminal Neuralgia

Primary Purpose

Trigeminal Neuralgia

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
trigminal nerve block with RFT
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring trigeminal neuralgia, cytokine, neurotransmitter

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hong ji HEERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TN patients with intervention

Control group

Arm Description

Patients with TN receiving 2 times of trigeminal nerve block and radiofrequency thermocoagulation

Healthy volunteer without any intervention

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Changes of numerical rating scale changes during 3 time period
numerical rating scale changes during 3 time period

Full Information

First Posted
December 15, 2022
Last Updated
July 3, 2023
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05685797
Brief Title
Biomarker Study in Patients With Trigeminal Neuralgia
Official Title
Inflammatory Cytokine and Neuropeptide Study in Patients With Trigeminal Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
trigeminal neuralgia, cytokine, neurotransmitter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TN patients with intervention
Arm Type
Experimental
Arm Description
Patients with TN receiving 2 times of trigeminal nerve block and radiofrequency thermocoagulation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Healthy volunteer without any intervention
Intervention Type
Procedure
Intervention Name(s)
trigminal nerve block with RFT
Intervention Description
trigminal nerve block with RFT
Primary Outcome Measure Information:
Title
serum level of inflammatory cytokine changes during 3 time period
Description
inflammatory cytokine including Tumor necrosis factor-alpha, Interleukin-6 changes during 3 time period Higher score means worse outcome
Time Frame
Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
Title
serum level of neurotransmitter changes during 3 time period
Description
neurotransmitter including Calcitonene gene related peptide, substance P, vasoactive intestitinal polypeptide changes during 3 time period Higher score means worse outcome
Time Frame
Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
Secondary Outcome Measure Information:
Title
Changes of numerical rating scale changes during 3 time period
Description
numerical rating scale changes during 3 time period
Time Frame
Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji H Hong
Phone
01046794343
Email
swon13@daum.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sung W Jung
Phone
01021064343
Email
swon12@daum.net
Facility Information:
Facility Name
Hong ji HEE
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Hee Hong
Phone
82-53-258-7767
Email
swon13@daum.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Biomarker Study in Patients With Trigeminal Neuralgia

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