Focused Ultrasound Therapy

Clinical Trials SquareFocused 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 epilepsy. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces two therapeutic effects that are being evaluated. One mechanism is thermal ablation, which heats and destroys the targeted tissue. Another is the use of neuromodulation, where focused ultrasound is able to lower the impact of epileptic impulses.

Advantages
Current treatments for epilepsy include medication, surgery, radiofrequency or laser ablation, deep brain stimulation, and stereotactic radiosurgery, all of which have limitations and side effects.

Focused ultrasound has the potential to provide an alternative to invasive surgery or to replace or augment radiosurgery for treatment of epilepsy. There are no incisions, no ionizing radiation, and no damage to surrounding healthy tissue. Focused ultrasound is noninvasive, requiring no incisions, holes in the skull, nore electrodes in the brain, and therefore has reduced risk for infection, blood clots, and mechanical tissue damage. Focused ultrasound may also be able to enhance delivery of drug therapies to the brain via temporary opening of the blood-brain barrier, reducing toxicity and side-effects.

Clinical Trials

A current clinical trial at Taipei Veteran’s General Hospital is using neuro-navigation to treat patients with refractory epilepsy.

A current clinical trial is underway at the University of Virginia, for patients with medication-refractory epilepsy with subcortical focal lesions. 

Another clinical trial at the Brigham and Women’s University is enrolling patients with drug resistant temporal lobe epilepsy.

The Ohio State University has a current clinical trial for patients to prevent the secondary generalization from focal onset epilepsy. 

A current clinical trial is underway at the University of California Los Angeles for medication-refractory epilepsy in patients with subcortical lesions. 

Regulatory Approval and Reimbursement

Focused ultrasound is not approved by any regulatory bodies worldwide as a treatment for epilepsy, nor is the treatment reimbursed by medical insurance providers.

Preclinical Laboratory Studies

Preclinical studies are underway to investigate the use of various mechanisms of focused ultrasound in the treatment of epilepsy. Examples of these studies include:

  • Focused ultrasound to temporarily disrupt the BBB and deliver promising drug therapies, including the dosing and timing (e.g. frequency) of drug administration.
  • Focused ultrasound to induce neuromodulation, to stimulate or block signals in a specific area of the brain that are causing symptoms such as seizure.

Notable Papers

Suggested Reading: Focused Ultrasound for Epilepsy (PDF), June 2020.

Yamaguchi T, Hori T, Hori H, Takasaki M, Abe K, Taira T, Ishii K, Watanabe K. Magnetic resonance-guided focused ultrasound ablation of hypothalamic hamartoma as a disconnection surgery: a case report. Acta Neurochir (Wien). 2020 Jul 2. doi: 10.1007/s00701-020-04468-6.

Lin Z, Meng L, Zou J, Zhou W, Huang X, Xue S, Bian T, Yuan T, Niu L, Guo Y, Zheng H. Non-invasive ultrasonic neuromodulation of neuronal excitability for treatment of epilepsy. Theranostics 2020; 10(12):5514-5526. doi:10.7150/thno.40520

Abe K, Yamaguchi T, Hori H, Sumi M, Horisawa S, Taira T, Hori T. Magnetic resonance-guided focused ultrasound for mesial temporal lobe epilepsy: a case report. BMC Neurol. 2020 Apr 29;20(1):160. doi: 10.1186/s12883-020-01744-x.

Zhang Y, Zhou H, Qu H, Liao C, Jiang H, Huang S, Ghobadi SN, Telichko A, Li N, Habte FG, Doyle T, Woznak JP, Bertram EH, Lee KS, Wintermark M. Effects of Non-invasive, Targeted, Neuronal Lesions on Seizures in a Mouse Model of Temporal Lobe Epilepsy. Ultrasound Med Biol. 2020 Feb 17. pii: S0301-5629(20)30010-7. doi: 10.1016/j.ultrasmedbio.2020.01.008.

Chen SG, Tsai CH, Lin CJ, Lee CC, Yu HY, Hsieh TH, Liu HL.Transcranial focused ultrasound pulsation suppresses pentylenetetrazol induced epilepsy in vivo. Brain Stimul. 2019 Sep 24. pii: S1935-861X(19)30374-2. doi: 10.1016/j.brs.2019.09.011.

Agnese V, Costa V, Scoarughi GL, Corso C, Carina V, De Luca A, Bellavia D, Raimondi L, Pagani S, Midiri M, Stassi G, Alessandro R, Fini M, Barbato G, Giavaresi G. Focused Ultrasound Effects on Osteosarcoma Cell Lines. Biomed Res Int. 2019 May 19;2019:6082304. doi: 10.1155/2019/6082304. eCollection 2019.

Parker WE, Weidman EK, Chazen JL, Niogi SN, Uribe-Cardenas R, Kaplitt MG, Hoffman CE. Magnetic resonance-guided focused ultrasound for ablation of mesial temporal epilepsy circuits: modeling and theoretical feasibility of a novel noninvasive approach. J Neurosurg. 2019 Jun 14:1-8. doi: 10.3171/2019.4.JNS182694. [Epub ahead of print] PMID: 31200385

Vejay N. Vakharia, MRCS , John S. Duncan, FRCP, Juri-Alexander Witt, PhD, Christian E. Elger, FRCP, Richard Staba, PhD, and Jerome Engel Jr, PhD. Getting the Best Outcomes from Epilepsy Surgery. ANN NEUROL 2018;83:676–690

Piper RJ, Hughes MA, Moran CM, Kandasamy J. Focused ultrasound as a non-invasive intervention for neurological disease: a review. Br J Neurosurg. 2016 Jun;30(3):286-93. doi: 10.3109/02688697.2016.1173189. Epub 2016 Apr 22.

Monteith S, Snell J, Eames M, Kassell NF, Kelly E, Gwinn R. Transcranial magnetic resonance-guided focused ultrasound for temporal lobe epilepsy: a laboratory feasibility study. J Neurosurg. 2016 Feb 12:1-8.

Kang JY, Wu C, Tracy J, Lorenzo M, Evans J, Nei M, Skidmore C, Mintzer S, Sharan AD, Sperling MR. Laser interstitial thermal therapy for medically intractable mesial temporal lobe epilepsy. Epilepsia. 2016 Feb;57(2):325-34. doi: 10.1111/epi.13284. Epub 2015 Dec 24.

Quigg M, Harden C. Minimally invasive techniques for epilepsy surgery: stereotactic radiosurgery and other technologies. J Neurosurg. 2014 Dec;121 Suppl:232-40. doi: 10.3171/2014.8.GKS141608. Review.

Wynn Legon, Tomokazu F Sato, Alexander Opitz, Jerel Mueller, Aaron Barbour, Amanda Williams & William J Tyler. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nature Neuroscience (2014).

Jolesz FA, McDannold NJ. Magnetic resonance-guided focused ultrasound: a new technology for clinical neurosciences. Neurol Clin. 2014 Feb;32(1):253-69.

Dallapiazza R, McKisic MS, Shah B, Elias WJ. Neuromodulation for movement disorders. Neurosurg Clin N Am. 2014 Jan;25(1):47-58.

Click here for additional references from PubMed.

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