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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

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Study Contact

Study Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. 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;
  2. Age from 30 to 60 years old
  3. Complete white blood cell count: 4.8~11.0x109/L

Exclusion Criteria:

  1. Patients with co-infection and tumor
  2. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020PHB265-01

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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