NCT05122403

Multimodal MRI for MRgFUS Central Lateral Thalamotomy in Neuropathic Pain

Multimodal Magnetic Resonance Imaging Study for Magnetic Resonance-Guided Focused Ultrasound Central Lateral Thalamotomy in Neuropathic Pain

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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：Baseline, 3-day, 1-month, 3-months, 6-months,12-months

Conditions

• Neuropathic Pain
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
PROCEDURE	MRgFUS central lateral thalamotomy	MRgFUS central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-08-15
• Completion: 2026-07-15
• First posted: 2021-11-16
• Last updated: 2021-11-16

Locations

1 site across 1 country: China