Trigeminal NeuralgiaNCT04923399
Transcriptome Sequencing Analysis of Whole Blood From Patients With Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia and Blood, run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Trigeminal Neuralgia, Blood, Plasma
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Jun 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with co-infection and tumor
- Patients with craniocerebral disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Trigeminal Neuralgia, Blood, Plasma, Cerebrospinal Fluid
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score (VAS)
VAS score is a pain score
Measured: 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
Measured: 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.
Measured: 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
Measured: Cerebrospinal fluid will be collected during the surgery; Plasma will be collected before the surgery in the preoperative preparation room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, MD, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923399
- Sponsor's protocol ID
- 2020PHB265-01
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
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.
PubMed 25750533Song 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.
PubMed 30507652Eroli 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.
PubMed 29225040Liu 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.
PubMed 38300339
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptome Sequencing Analysis of Whole Blood From Patients With Trigeminal Neuralgia: An Observational Study
- ClinicalTrials.gov ID
- NCT04923399
- Acronym / sponsor ID
- 2020PHB265-01
- Conditions
- Trigeminal Neuralgia, Blood, Plasma, Cerebrospinal Fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TN (Trigeminal Neuralgia) group | – | –Trigeminal neuralgia patients undergoing trigeminal nerve microvascular decompression |
| Non-TN group | – | –patients without chronic pain or history of chronic pain |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with co-infection and tumor
- Patients with craniocerebral disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analogue Score (VAS)
Time frame: The VAS score is tested before surgery in the preoperative preparation room
VAS score is a pain score
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
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Background: PubMed 25750533Montano 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.
- Background: PubMed 30507652Song 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.
- Background: PubMed 29225040Eroli 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.
- Derived from this study: PubMed 38300339Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Feng, MD, PhD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia and Blood, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Feng, MD,PhD (+861088325581, yifeng65@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS) (time frame: The VAS score is tested before surgery in the preoperative preparation room). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923399, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.