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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male and female, aged between 18 and 75 (inclusive);

• Subjects who are able and willing to participate in the study;

• Chronic neuropathic pain with disease duration lasting more than 6 months;

• The worst NPRS score was ≥ 5 (out of 10), and the subjects reported a similar degree of pain in at least the past two months;

• Medication-refractory neuropathic pain with resistance to at least three kinds of neuropathic pain prescription drugs and one interventional procedure

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Hao-xuan Lu
plaluhaoxuan@163.com
+86-13044270958
Backup
Xin Lou, MD
+86-13044270958
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 12
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov