Key Points
- Final results from the first clinical trial in the US using focused ultrasound ablation to treat refractory neuropathic pain have been published.
- The procedure was feasible and safe and could potentially be used to reduce pain in these patients.
Researchers at the University of Maryland Medical Center have published the final results from the first US clinical trial treating refractory neuropathic pain with focused ultrasound–induced central lateral thalamotomy (CLT). The publication, in the journal Neurosurgery, is titled, “Focused Ultrasound Central Lateral Thalamotomy for the Treatment of Refractory Neuropathic Pain: Phase I Trial.” Led by Dheeraj Gandhi, MD, the prospective, nonrandomized, single-arm, investigator-initiated phase I trial used Insightec’s Exablate Neuro device and was funded by the Focused Ultrasound Foundation.
Neuropathic pain is a type of chronic pain caused by nerve damage or a malfunctioning nervous system. It can cause significant disability, depression, and sleep problems. Dr. Daniel Jeanmonod in Switzerland pioneered the use of focused ultrasound for treating neuropathic pain.
The study team at the University of Maryland consisted of a multidisciplinary panel of physicians, including a neurointerventionalist, a neurosurgeon, a neurologist, and pain specialists.
To achieve its main goals to assess safety and potential efficacy, the US clinical trial enrolled 10 patients with various types of neuropathic pain that had lasted longer than six months and did not respond to one or more previous interventions. The participants had a mean age of 50.9 years and symptoms that had lasted an average of 12.3 years.
Nine of the participants had a successful CLT ablation, and eight of those reached the one-year follow-up assessment. The group reported 12 mild or moderate adverse events, but no serious adverse events. After one year, pain scores had decreased by 46.3% on one scale (brief pain inventory) and by 42.8% on another (numeric rating). Their pain disability index decreased an average of 39.3%.
Two of the participants in this study, Tammy and Terri (seen in the video), shared their experiences undergoing a focused ultrasound brain treatment.
“We were pleased to see that bilateral treatment of the central lateral thalamus successfully reduced pain scores by over 40% at one year, with no major adverse side effects,” said Timothy D. Meakem, MD, the Foundation’s Chief Medical Officer. “It has traditionally been challenging for the US Food and Drug Administration (FDA) to approve treatments for subjective pain, so Dr. Gandhi is in discussions with the FDA to help determine whether a larger clinical trial will be planned.”
The researchers concluded that CLT was feasible and safe for treating neuropathic pain and that it could potentially be used to reduce symptoms of pain, especially in patients with intermittent pain or pain from stimuli that do not normally cause pain (allodynia). Medication use also decreased in some of the patients.
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A Focused Ultrasound Patient Story: Terri (Neuropathic Pain) September 2021
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First Patient Treated in U.S. Neuropathic Pain Clinical Trial October 2018
Patient Finds Relief for Chronic Neuropathic Pain October 2018 (And see University of Maryland’s video of Tammy dancing after the procedure.)
Investigator Profile: Dheeraj Gandhi, MD October 2018