Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia

NCT06853119 | Not Yet Recruiting DMC

• 1 other identifier: 2024S240
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Trigeminal Neuralgia (TN)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Brief Pain Inventory (BPI)

  Baseline, until to discharge (an average of 3 days), 3 months after surgery

• Simplified McGill pain questionnaire (SF-MPQ)

  Baseline, 3 months after surgery

• Douleur Neuropathique 4 Questions (DN4)

  Baseline, 3 months after surgery

• Beck Depression Inventory (BDI)

  Baseline, 3 months after surgery

• Beck Anxiety Inventory (BPI)

  Baseline, 3 months after surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 28, 2025
• Study Start: March 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 30, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02