Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia
ConditionTrigeminal Neuralgia (TN)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.);
Trial population
Patients with TN undergoing PBC and healthy controls matched by age and sex.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Trigeminal Neuralgia Group
Group B: Health Control Group
Trial outcomes
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 ).
Time frame
Preoperative routine MRI examinationSecondary outcomes
1
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."
Time frame
Baseline, until to discharge (an average of 3 days), 3 months after surgery2
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.
Time frame
Baseline, 3 months after surgery3
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
Time frame
Baseline, 3 months after surgery4
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.
Time frame
Baseline, 3 months after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: