- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923399
Transcriptome Sequencing Analysis of Whole Blood From Patients With Trigeminal Neuralgia
June 6, 2021 updated by: Yi Feng, MD, Peking University People's Hospital
Transcriptome Sequencing Analysis of Whole Blood From Patients With Trigeminal Neuralgia: An Observational Study
Trigeminal neuralgia is a type of neuropathic pain that brings great physical and psychological pressure to patients.
Chronic pain can cause changes in the composition of central and peripheral body fluids, and these changes may be useful for the prediction and treatment of pain.
In this study, the whole blood of patients with trigeminal neuralgia and non-chronic pain was collected, and transcriptome sequencing (RNA-seq) was performed to determine the peripheral transcriptome changes of trigeminal neuralgia (TN) patients.
And compare the expression of neuropeptide Y (NPY) in plasma and cerebrospinal fluid of TN and non-chronic pain patients.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Trigeminal neuralgia is a kind of paroxysmal, knife-cutting, stubborn and severe pain in the facial distribution area of the trigeminal nerve caused by slight stimulation, which brings a great physical and psychological burden to the patient.
Chronic pain can cause changes in the composition of central and peripheral body fluids, and these changes are very useful for the prediction and treatment of pain.
In this study, the whole blood of patients with trigeminal neuralgia and non-chronic pain was collected for transcriptome sequencing (RNA-seq) sequencing.
The results of transcriptome sequencing can derive the differentially expressed genes in the whole blood of TN patients and the pathways enriched by differentially expressed genes.
At the same time, NPY (Neuropeptide y) plays an important role in head and face pain.
We will also verify the difference in NPY expression in the cerebrospinal fluid and plasma of TN and non-chronic pain patients, and the correlation between NPY expression and pain.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Feng, MD,PhD
- Phone Number: +861088325581
- Email: yifeng65@sina.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Trigeminal neuralgia patients receive the trigeminal nerve microvascular decompression surgery.
The comparsion group is patients without chronic pain or history of chronic pain.
The whole blood cell, plasma and cerebrospinal fluid will be collected during the perioperative period.
Description
Inclusion Criteria:
- Patients with primary trigeminal neuralgia receive trigeminal nerve microvascular decompression, and healthy people without a history of chronic pain or patients with facial nerve palsy without chronic pain receive facial nerve decompression as a control;
- Age from 30 to 60 years old
- Complete white blood cell count: 4.8~11.0x109/L
Exclusion Criteria:
- Patients with co-infection and tumor
- Patients with craniocerebral disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
TN (Trigeminal Neuralgia) group
Trigeminal neuralgia patients undergoing trigeminal nerve microvascular decompression
|
|
Non-TN group
patients without chronic pain or history of chronic pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Score (VAS)
Time Frame: The VAS score is tested before surgery in the preoperative preparation room
|
VAS score is a pain score
|
The VAS score is tested before surgery in the preoperative preparation room
|
|
Differentially expressed genes
Time Frame: blood will be taken from two groups of patients before operation
|
Transcriptome analysis of whole blood cell from patients with trigeminal neuralgia or non-chronic pain reveals differential gene expression between the two groups
|
blood will be taken from two groups of patients before operation
|
|
Differentially expressed genes (DEGs) enrichment pathway
Time Frame: blood will be taken from two groups of patients before operation
|
We will perform pathway enrichment analysis on the DEGs obtained by transcriptome analysis of the whole blood cell from patients with trigeminal neuralgia or non-chronic pain.
|
blood will be taken from two groups of patients before operation
|
|
Neuropeptide y expression
Time Frame: Cerebrospinal fluid will be collected during the surgery; Plasma will be collected before the surgery in the preoperative preparation room.
|
We detect neuropeptide Y levels in the cerebrospinal fluid and plasma of patients with trigeminal neuralgia and non-chronic pain
|
Cerebrospinal fluid will be collected during the surgery; Plasma will be collected before the surgery in the preoperative preparation room.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Montano N, Conforti G, Di Bonaventura R, Meglio M, Fernandez E, Papacci F. Advances in diagnosis and treatment of trigeminal neuralgia. Ther Clin Risk Manag. 2015 Feb 24;11:289-99. doi: 10.2147/TCRM.S37592. eCollection 2015.
- Song N, Liao DQ, Liu F, Zhang YY, Lin J, Wang H, Shen JF. Effect of Titanium Particles on the Voltage-Gated Potassium Channel Currents in Trigeminal Root Ganglion Neurons. Implant Dent. 2019 Feb;28(1):54-61. doi: 10.1097/ID.0000000000000848.
- Eroli F, Loonen ICM, van den Maagdenberg AMJM, Tolner EA, Nistri A. Differential neuromodulatory role of endocannabinoids in the rodent trigeminal sensory ganglion and cerebral cortex relevant to pain processing. Neuropharmacology. 2018 Mar 15;131:39-50. doi: 10.1016/j.neuropharm.2017.12.013. Epub 2017 Dec 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
June 6, 2021
First Submitted That Met QC Criteria
June 6, 2021
First Posted (Actual)
June 11, 2021
Study Record Updates
Last Update Posted (Actual)
June 11, 2021
Last Update Submitted That Met QC Criteria
June 6, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PHB265-01
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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