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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.
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:
Treatment:
MRgFUS central lateral thalamotomy
Follow-up:
MRI + clinical evaluation:Baseline, 3-day, 1-month, 3-months, 6-months,12-months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FUS Thalamotomy | The cohort includes patients with neuropathic pain who underwent MRgFUS central lateral thalamotomy. |
| |
| Sham Procedure | The cohort includes patients with neuropathic pain who underwent sham MRgFUS central lateral thalamotomy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRgFUS central lateral thalamotomy | Procedure | MRgFUS central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients. |
| Measure | Description | Time Frame |
|---|---|---|
| primary efficacy outcome(Numerical Pain Rating Scale score) | The primary efficacy outcome was determined by comparing the change from baseline to 3 months in the NPRS (Numerical Pain Rating Scale) score between FUS thalamotomy and sham procedures using intention-to-treat analysis. | 1 years |
| Primary safety outcome(incidence and severity of adverse events) | Primary safety outcome was assessed by monitoring the incidence and severity of the procedure-related adverse events from the procedure through 1 year after treatment for all patients | 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Chronic Neuropathic Pain
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao-xuan Lu | Contact | +86-13044270958 | plaluhaoxuan@163.com | |
| Xin Lou, MD | Contact | +86-13044270958 |
| Name | Affiliation | Role |
|---|---|---|
| Xin Lou, MD | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |