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 range21 Years – 75 Years
SexALL
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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
✕. 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
✕
What they're measuring
1
Incidence of Treatment related adverse events
Timeframe: All events will be reported upto 12 months from treatment
. 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.