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Not yet recruiting NCT06853119

Magnetic Resonance Imaging in Patients with Trigeminal Neuralgia

— Observational Trigeminal Neuralgia (TN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Trigeminal Neuralgia (TN). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • Scanning sequence of magnetic resonance imaging (MRI) [Time frame: Preoperative routine MRI examination]
Secondary outcome measures (8)
  • Brief Pain Inventory (BPI) [Time frame: Baseline, until to discharge (an average of 3 days), 3 months after surgery]
  • Simplified McGill pain questionnaire (SF-MPQ) [Time frame: Baseline, 3 months after surgery]
  • Douleur Neuropathique 4 Questions (DN4) [Time frame: Baseline, 3 months after surgery]
  • Beck Depression Inventory (BDI) [Time frame: Baseline, 3 months after surgery]
  • Beck Anxiety Inventory (BPI) [Time frame: Baseline, 3 months after surgery]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, 3 months after surgery]
  • Blood immune inflammation indicators [Time frame: Baseline]
  • PBC asscoated adverse reactions [Time frame: 24 hours after surgery, 3 months after surgery]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06853119 · 2024S240

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗