Trigeminal Neuralgia (TN)NCT06853119
Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia (TN), run by Tongji Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia (TN)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 30 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with TN undergoing PBC and healthy controls matched by age and sex.
Who may be able to join
- 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
Who cannot join
- 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.)
About this study
Official title: 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
- Conditions
- Trigeminal Neuralgia (TN)
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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 ).
Measured: Preoperative routine MRI examination
Secondary outcomes (8)
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."
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 24 hours after surgery, 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Mar 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal Neuralgia (TN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853119
- Sponsor's protocol ID
- 2024S240
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No