MR Guided Focused Ultrasound for Treatment of Neuropathic Pain (NCT03111277) | Clinical Trial Compass
CompletedNot Applicable
MR Guided Focused Ultrasound for Treatment of Neuropathic Pain
United States10 participantsStarted 2017-09-15
Plain-language summary
Neuropathic pain is often a result of direct diseases of peripheral or central nervous system with an estimated prevalence of 8% of adults and this pain is associated with significant consequences because of longer symptom duration and severity than many of the other pain syndromes. Functional brain imaging has revealed that many regions of the brain are engaged by painful events, but specific areas such as the thalamus have been markedly implicated.
The purpose of this study is to determine the feasibility and safety of MRI-guided focused ultrasound treatment using the ExAblate Transcranial System in patients suffering from Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for these patients.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Severe uncontrolled neuropathic pain due to radiculopathy or radicular injury
. Spinal Cord Injury
. Phantom Limb Pain
Exclusion criteria
. Age greater than 21 and less than 75 years
. Subjects who are able and willing to give consent and able to attend all study visits,
. Documented Neuropathic pain for more than 6 months duration, confirmed from clinical history and examination by a pain specialist or neurologist
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
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?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
What they're measuring
1
Incidence of Treatment related adverse events
Timeframe: All events will be reported upto 12 months from treatment
. Failure to respond to any of the usual therapeutic regimens considered to be standard of care for neuropathic pain. The patient should have failed a trial of at least three pain medications, including at least one opioid agent
. Patients with radiculopathy or radicular injury or phantom limb pain should have failed one additional pain intervention such as nerve block, epidural steroid injection, motor cortex or spinal cord stimulator
. Patients with Spinal cord injury, in addition to having failed a trial of three pain medications, should have failed one additional intervention such as Botox injection or intra-thecal baclofen.
. Subjects should have been on stable dose of analgesic agents for at least a period of 4 weeks
. Clinical symptoms consistent with persistent, intractable pain that has remained at average NRS score \>5 for 30 days, significant pain related disability (Pain Disability Index (PDI) score \>30) or severe allodynia.