Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05685797
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2022-12-15
Brief Title:
Biomarker Study in Patients With Trigeminal Neuralgia
Sponsor:
Keimyung University Dongsan Medical Center
Organization:
Keimyung University Dongsan Medical Center
Study Overview
Official Title:
Inflammatory Cytokine and Neuropeptide Study in Patients With Trigeminal Neuralgia
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 717 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
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 717 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None