Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04923399
Other study ID # 2020PHB265-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date June 1, 2023

Study information

Verified date June 2021
Source Peking University People's Hospital
Contact Yi Feng, MD,PhD
Phone +861088325581
Email yifeng65@sina.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Score (VAS) VAS score is a pain score The VAS score is tested before surgery in the preoperative preparation room
Primary 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
Primary 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
Primary 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.
See also
  Status Clinical Trial Phase
Recruiting NCT05152368 - Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy Phase 1
Recruiting NCT02801630 - An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia N/A
Completed NCT02473016 - Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia Phase 2
Recruiting NCT01364259 - A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia Phase 3
Completed NCT01364272 - Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
Completed NCT00603694 - Hippocampal Radiation Exposure and Memory N/A
Completed NCT00913107 - Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia Phase 2/Phase 3
Recruiting NCT04996199 - Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial Phase 4
Completed NCT06240494 - Predictive Factors in Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
Completed NCT05712993 - Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers N/A
Completed NCT04371575 - Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients
Completed NCT03669744 - Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
Completed NCT05032573 - Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia N/A
Recruiting NCT05615714 - Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial) Phase 1/Phase 2
Recruiting NCT04054024 - Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia Phase 2
Not yet recruiting NCT05451251 - Deep Brain Stimulation for Refractory Trigeminal Neuralgia With a Demyelinating Pontine Lesion N/A
Withdrawn NCT04353505 - Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache Phase 1
Withdrawn NCT01932255 - CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap N/A
Completed NCT05075707 - Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia N/A
Completed NCT06334796 - Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology Early Phase 1