NCT04923399

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 6, 2021

Last Update Submit

June 6, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Score (VAS)

    VAS score is a pain score

    The VAS score is tested before surgery in the preoperative preparation room

  • Differentially expressed genes

    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

    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

    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.

Study Arms (2)

TN (Trigeminal Neuralgia) group

Trigeminal neuralgia patients undergoing trigeminal nerve microvascular decompression

Non-TN group

patients without chronic pain or history of chronic pain

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with co-infection and tumor
  • Patients with craniocerebral disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25750533BACKGROUND
  • 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.

    PMID: 30507652BACKGROUND
  • 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.

    PMID: 29225040BACKGROUND
  • Liu T, Xu C, Guo J, He Z, Zhang Y, Feng Y. Whole Blood Transcriptome Analysis in Patients with Trigeminal Neuralgia: a Prospective Clinical Study. J Mol Neurosci. 2024 Feb 1;74(1):16. doi: 10.1007/s12031-024-02195-6.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood cell; plasma; cerebrospinal fluid

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Yi Feng, MD, PhD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Feng, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Anesthesiology Department

Study Record Dates

First Submitted

June 6, 2021

First Posted

June 11, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 11, 2021

Record last verified: 2021-06