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临床试验/NCT06853119
NCT06853119尚未招募不适用

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

Tongji Hospital0 个研究点目标入组 120 人开始时间: 2025年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Scanning sequence of magnetic resonance imaging (MRI)

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.)

结局指标

主要结局

Scanning sequence of magnetic resonance imaging (MRI)

时间窗: 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 ).

次要结局

  • Brief Pain Inventory (BPI)(Baseline, until to discharge (an average of 3 days), 3 months after surgery)
  • Simplified McGill pain questionnaire (SF-MPQ)(Baseline, 3 months after surgery)
  • Douleur Neuropathique 4 Questions (DN4)(Baseline, 3 months after surgery)
  • Beck Depression Inventory (BDI)(Baseline, 3 months after surgery)
  • Beck Anxiety Inventory (BPI)(Baseline, 3 months after surgery)
  • Pittsburgh Sleep Quality Index (PSQI)(Baseline, 3 months after surgery)
  • Blood immune inflammation indicators(Baseline)
  • PBC asscoated adverse reactions(24 hours after surgery, 3 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feng Gao

Professor

Tongji Hospital

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