Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia

Study on Brain Function and Structural Changes in Patients with Trigeminal Neuralgia Based on Magnetic Resonance Imaging.

This study intends to use MRI technology to analyze the dynamic changes and microstructure changes of the brain network in patients with trigeminal neuralgia, evaluate the blood-brain barrier and water exchange rate, and further analyze their correlation with clinical indicators, so as to explore the changes in brain structural plasticity and potential neural mechanisms

Study Overview

• Status: Not yet recruiting
• Conditions: Trigeminal Neuralgia (TN)

• Study Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with TN undergoing PBC and healthy controls matched by age and sex.

Description

Inclusion Criteria:

• The diagnosis was TN according to the ICHD.
• Patients requiring surgical treatment due to ineffective or intolerant treatment with carbamazepine or oxasepine before operation;
• First surgical treatment;
• Right-handed dominant;
• There was no significant loss of sensation

Exclusion Criteria:

• Secondary TN;
• Associated with other types of chronic pain or neuropsychiatric disorders;
• History of head trauma or stroke or cerebrovascular ischemia;
• History of microvascular decompression or other treatments (gamma knife radiosurgery, etc.);
• Unable to cooperate independently;
• Contraindications, such as uncontrolled infection, coagulopathy, etc.;
• MRIcontraindications (e.g., pacemaker, claustrophobia, etc.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Trigeminal Neuralgia Group; Patients who were diagnosed with trigeminal neuralgia (TN) according to the International Classification of Headache Disorders (ICHD) and were intolerant or ineffective to the preoperative treatment of carbamazepine or ocasepine, requiring the treatment of percutaneous balloon compression (PBC)
Health Control Group; Healthy controls matched by age, sex, etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scanning sequence of magnetic resonance imaging (MRI)	such as 3D-T1, 3D-T2, BOLD-functional MRI (fMRI), diffusion weighted imaging (DWI) (Multiple b values, such as 0,1000,2000), diffusion-prepared, arterial spin labeling (DP-ASL), Meningeal lymphatic sequence (3D T2-FLAIR ).	Preoperative routine MRI examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory (BPI)	The BPI is divided into two parts, one of which assesses pain severity on a scale of 0 to 10, where 0 means "no pain" and 10 means "most severe pain." The other assessed the extent to which pain interfered with daily activities, including seven areas of general activity, mood, ability to walk, normal work (including housework), relationships, sleep, and enjoyment of life, with 0 being "no impact" and 10 being "significant impact."	Baseline, until to discharge (an average of 3 days), 3 months after surgery
Simplified McGill pain questionnaire (SF-MPQ)	The scale consisted of two subscales with 11 pain description items and 4 emotional assessment items [pain-free (0), mild (1), moderate (2), severe (3)], and a visual analog scale (VAS) [0-10, painless (0), severe pain (10)] was added to assess pain intensity.	Baseline, 3 months after surgery
Douleur Neuropathique 4 Questions (DN4)	The scale contains 10 items, divided into two parts: Symptom description (7 items) : covers burning pain, cold pain, electric shock pain, tingling pain, acupuncture pain, numbness, and pruritus. Clinical examination (3 items) : Includes loss of touch, loss of tingling, and whether rubbing in the pain area induces or worsens pain. "Yes" scores 1 point for each item, "no" scores 0 points, total score ≥4 points can be diagnosed as neuropathic pain	Baseline, 3 months after surgery
Beck Depression Inventory (BDI)	BDI consists of 21 items, each corresponding to a common depressive symptom, such as sadness, insomnia, fatigue and feelings of worthlessness. Each item has four options, representing the severity of symptoms, on a scale of 0 (no symptoms) to 3 (severe symptoms). The overall score ranges from 0 to 63, with the higher the score, the more severe the depressive symptoms.	Baseline, 3 months after surgery
Beck Anxiety Inventory (BPI)	BAI consists of 21 items, each describing an anxiety-related symptom, and subjects are required to choose the answer that best fits their situation based on their feelings in the past week. A 4-level scoring method was adopted: 0: None; Mild, not much bother; Moderate, uncomfortable but tolerable; severe, can only barely tolerate The higher the score, the more severe the anxiety symptoms.	Baseline, 3 months after surgery
Pittsburgh Sleep Quality Index (PSQI)	The PSQI contains 19 self-rated entries and 5 other rated entries, but only 19 self-rated entries participate in the score. The entries are divided into seven components, each scored on a 0-3 scale, with an overall score ranging from 0-21.	Baseline, 3 months after surgery
Blood immune inflammation indicators	such as interleukin-1β (IL-1β), IL-2, IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), C-reactive protein (CRP), calcitonin gene-related peptide (CGRP), neurofilament light chain (sNfL), glial fibrillary acidic protein (sGFAP).	Baseline
PBC asscoated adverse reactions	such as hypoesthesia (numbness of the face and tongue), decreased corneal reflexes, dry eye, double vision, masseter weakness, oral herpes simplex	24 hours after surgery, 3 months after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: 2024S240

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No