Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-02 @ 9:08 AM
Study NCT ID:
NCT05122403
Status:
RECRUITING
Last Update Posted:
2021-11-16
First Post:
2021-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal MRI for MRgFUS Central Lateral Thalamotomy in Neuropathic Pain
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Multimodal Magnetic Resonance Imaging Study for Magnetic Resonance-Guided Focused Ultrasound Central Lateral Thalamotomy in Neuropathic Pain
Status:
RECRUITING
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: