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Clinical Trial Summary

To explore the pathogenesis underlying neuropathic pain as well as the mechanisms of pain relief after Magnetic resonance-guided focused ultrasound (MRgFUS) Central Lateral Thalamotomy through multi-model MRI study, and to identify imaging biomarkers for triaging patients and predicting the clinical outcomes. Craniofacial neuropathic pain is one of the most serious debilitating symptoms, leading to emotional disorders and poor quality of life. Previous studies have shown that Magnetic resonance-guided focused ultrasound (MRgFUS) central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients. However, the clinical benefits were variable among individuals. It is important to clarify the pathogenesis of neuropathic pain and the mechanisms of pain relief induced by MRgFUS central lateral thalamotomy to triage suitable candidates for the procedure and predict clinical outcomes. In addition, localization precision and individualized treatment remain to be improved.


Clinical Trial Description

The study was designed as a prospective, sham-controlled randomized clinical trial (randomized 1:1) with double-blinded assessments through the 3-month primary end point analysis. Patients assigned to a sham procedure were offered open label treatment after the 3-month blinded assessment. All treated patients were followed unblinded to 1 year. Baseline clinical demographics, Numerical Pain Rating Scale (NPRS) treatment parameters (energy, power, duration time, temperature, target location) , associated adverse effects were recorded Imaging protocols: T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI Imaging evaluation: 1. Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1; 2. ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively; 3. ASL shows regional cerebral blood flow associated with the procedure; 4. DTI demonstrates the destruction of white matter integrity. 5. Rs-functional MRI reflects alterations of resting-state brain activity. Treatment: MRgFUS central lateral thalamotomy Follow-up: MRI + clinical evaluation´╝ÜBaseline, 3-day, 1-month, 3-months, 6-months,12-months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05122403
Study type Observational
Source Chinese PLA General Hospital
Contact Hao-xuan Lu
Phone +86-13044270958
Email [email protected]
Status Recruiting
Phase
Start date December 1, 2021
Completion date July 15, 2026

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