Using MRI to understand pain relief from focused ultrasound treatment in neuropathic pain
Multimodal Magnetic Resonance Imaging Study for Magnetic Resonance-Guided Focused Ultrasound Central Lateral Thalamotomy in Neuropathic Pain
This study is testing if focused ultrasound treatment can help relieve neuropathic pain and using MRI to see how it works and who might benefit the most.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05122403 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the underlying causes of neuropathic pain and the mechanisms of pain relief achieved through Magnetic Resonance-guided focused ultrasound (MRgFUS) central lateral thalamotomy. It employs a multimodal MRI approach to identify imaging biomarkers that can help in selecting suitable candidates for the procedure and predicting clinical outcomes. The study involves a prospective, sham-controlled randomized design with double-blinded assessments over a 3-month period, followed by unblinded follow-ups for up to one year. Various MRI imaging protocols will be utilized to evaluate changes in brain structure and function associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with chronic neuropathic pain lasting more than 6 months and who have not responded to multiple pain medications.
Not a fit: Patients with craniofacial pain syndromes related to malignancies, idiopathic trigeminal neuralgia, or other specific headache syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection and outcomes for those suffering from medication-refractory neuropathic pain.
How similar studies have performed: Previous studies have indicated that MRgFUS central lateral thalamotomy is effective for certain patients, but this study aims to refine candidate selection and predict outcomes, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female, aged between 18 and 75 (inclusive); 2. Subjects who are able and willing to participate in the study; 3. Chronic neuropathic pain with disease duration lasting more than 6 months; 4. 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; 5. Medication-refractory neuropathic pain with resistance to at least three kinds of neuropathic pain prescription drugs and one interventional procedure Exclusion Criteria: 1. Craniofacial pain syndrome associated with malignant tumors of the head and neck; 2. Idiopathic trigeminal neuralgia; 3. Headache syndrome, such as migraine; 4. Temporomandibular joint syndrome; 5. Atypical facial pain or pain related to somatoform disorders; 6. Subjects are regarded as unqualified candidates by experts; 7. active mental illness; 8. unstable heart state; 9. severe hypertension (diastolic blood pressure after taking medicine \>100mm/Hg) 10. MR imaging standard contraindications, such as non-MRI compatible implanted metal devices, including pacemakers.
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hao-xuan Lu
- Email: plaluhaoxuan@163.com
- Phone: +86-13044270958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.