Trigeminal Neuralgia (TN)
Conditions
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
Interventions
None listed
Sponsors
Tongji Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scanning sequence of magnetic resonance imaging (MRI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Simplified McGill pain questionnaire (SF-MPQ) | 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. |
| Douleur Neuropathique 4 Questions (DN4) | 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 |
| Beck Depression Inventory (BDI) | 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. |
| Brief Pain Inventory (BPI) | 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. |
| Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Blood immune inflammation indicators | 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). |
| PBC asscoated adverse reactions | 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 |
| Beck Anxiety Inventory (BPI) | 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 1. Mild, not much bother 2. Moderate, uncomfortable but tolerable 3. severe, can only barely tolerate The higher the score, the more severe the anxiety symptoms. |
Outcome results
None listed