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NCT Number: NCT06853119

Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Scanning sequence of magnetic resonance imaging (MRI)

    Time frame: Preoperative routine MRI examination

    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 ).

Secondary outcomes

  1. Brief Pain Inventory (BPI)

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

    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."

  2. Simplified McGill pain questionnaire (SF-MPQ)

    Time frame: Baseline, 3 months after surgery

    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.

  3. Douleur Neuropathique 4 Questions (DN4)

    Time frame: Baseline, 3 months after surgery

    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

  4. Beck Depression Inventory (BDI)

    Time frame: Baseline, 3 months after surgery

    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.

  5. Beck Anxiety Inventory (BPI)

    Time frame: Baseline, 3 months after surgery

    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.
  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, 3 months after surgery

    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.

  7. Blood immune inflammation indicators

    Time frame: Baseline

    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).

  8. PBC asscoated adverse reactions

    Time frame: 24 hours after surgery, 3 months after surgery

    such as hypoesthesia (numbness of the face and tongue), decreased corneal reflexes, dry eye, double vision, masseter weakness, oral herpes simplex

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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