Multimodal MRI for MRgFUS Central Lateral Thalamotomy in Neuropathic Pain (NCT05122403) | Clinical Trial Compass
RecruitingNot Applicable
Multimodal MRI for MRgFUS Central Lateral Thalamotomy in Neuropathic Pain
China12 participantsStarted 2021-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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Inclusion criteria
. 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
Exclusion criteria
. Craniofacial pain syndrome associated with malignant tumors of the head and neck;
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.