Outside Approval Square

Focused Ultrasound Therapy

Focused ultrasound is an early-stage, non-invasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with neuropathic pain. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue. Where the beams converge, the ultrasound produces precise ablation (thermal destruction of tissue) enabling neuropathic pain to be treated without surgery. While there are several potential treatment targets, the central lateral thalamus has been the target of initial studies.

The primary options for treatment of neuropathic pain include medication and invasive surgery (e.g. deep brain stimulation, radiofrequency lesioning).

Clinical Trials Square

For certain patients, focused ultrasound could provide a non-invasive alternative to surgery with less risk of complications and lower cost.

Advantages:

  • Focused ultrasound is non-invasive – no incisions, holes in the skull, electrodes in the brain – and therefore has reduced risk for infection and blood clots.
  • Precise targeting minimizes damage to non-targeted healthy brain.
  • Compared to deep brain stimulation, focused ultrasound is a single procedure, and does not require subsequent procedures/visits to replace batteries, repair broken wires, or adjust simulator settings. It also does not involve the collateral damage to healthy tissue or the risk of infections associated with implanting a foreign body.

Clinical Trials

University of Virginia
A clinical trial for treatment refractory, chronic trigeminal neuropathic pain. Please note that this study does not include trigeminal neuralgia.

University of Maryland.
This study targets the central lateral thalamus for treatment of patients with neuropathic pain. 

Israel.
Focused ultrasound is used to ablate painful neuromas (visualized on MRI) that are causing amputee stump pain, and the impact on the patient’s level of pain is assessed. 

See a full list of neuropathic pain clinical trials >

Treatment Sites

See a list of treatment sites >
See a list of clinical trials sites >
See a list of laboratory research sites >

Regulatory Approval and Reimbursement

Regulatory approvals in Europe, Korea, Middle East and Russia for the treatment of neuropathic pain have been achieved.  

Notable Papers

Prabhala T, Hellman A, Walling I, Maietta T, Qian J, Burdette C, Neubauer P, Shao M, Stapleton A, Thibodeau J, Pilitsis JG. External focused ultrasound treatment for neuropathic pain induced by common peroneal nerve injury. Neurosci Lett. 2018 Sep 25;684:145-151. doi: 10.1016/j.neulet.2018.07.037. Epub 2018 Jul 26.

Youn Y, Hellman A, Walling I, Gee L, Qian J, Burdette C, Frith L, Pilitsis JG. High-Intensity Ultrasound Treatment for Vincristine-Induced Neuropathic Pain. Neurosurgery. 2018 Nov 1;83(5):1068-1075. doi: 10.1093/neuros/nyx488.

Ghanouni P, Pauly KB, Elias WJ, Henderson J, Sheehan J, Monteith S, Wintermark M. Transcranial MRI-Guided Focused Ultrasound: A Review of the Technologic and Neurologic Applications. AJR Am J Roentgenol. 2015 Jul;205(1):150-9. doi: 10.2214/AJR.14.13632.

Varma P, Stineman MG, Dillingham TR. Epidemiology of limb loss. Phys Med Rehabil Clin N Am. 2014 Feb;25(1):1-8

Bauer R, Martin E, Haegele-Link S, Kaegi G, von Specht M, Werner B. Noninvasive functional neurosurgery using transcranial MR imaging-guided focused ultrasound. Parkinsonism Relat Disord. 2014 Jan;20 Suppl 1:S197-9.

Hsu E, Cohen SP. Postamputation pain: epidemiology, mechanisms, and treatment. J Pain Res. 2013;6:121-36.

Jeanmonod D, Werner B, Morel A, Michels L, Zadicario E, Schiff G, Martin E. Transcranial magnetic resonance imaging-guided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain. Neurosurg Focus. 2012 Jan;32(1):E1.

Martin E, Jeanmonod D, Morel A, Zadicario E, Werner B. High-intensity focused ultrasound for noninvasive functional neurosurgery. Ann Neurol. 2009 Dec;66(6):858-61.

Click here for additional references from PubMed.

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