Home Diseases and Conditions Epilepsy

Epilepsy

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound for this condition is being researched in clinical trials.

Overview

Focused ultrasound is a noninvasive, 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.

Benefits

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 radiosurgery for treatment of medication refractory epilepsy.

Advantages:

  • Noninvasive – no incisions, no risk of infection or bleeding, less pain, and rapid recovery
  • Image-guided – precision targeting with minimal damage to surrounding tissue
  • Real time target confirmation – using sub-ablative treatment parameters, the target can be tested for location accuracy prior to ablation
  • Safe, temporary and repetitive opening of the blood brain barrier (BBB) – enhancing the delivery of therapeutics directly to the brain target site
  • Fractionated ablation – ability to treat in a step-wise fashion in order to preserve tissue
  • No ionizing radiation – fewer side effects and can be safely repeated
  • Conformal – treatment confined within the boundaries of the entire targeted volume

Regulatory Authorizations

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

Clinical Trials

clinical trial in Virginia is treating patients with low intensity focused ultrasound to improve symptoms from their epilepsy. This trial is recruiting patients by invitation.  

A clinical trial in several states is using low frequency neuromodulation to treat those with drug resistant, unilateral or bilateral epilepsy with the NaviFUS system. 

A clinical trial in Ohio is treating patients with drug resistant epilepsy and anxiety with focused ultrasound ablation.  

A clinical trial in Taiwan is treating patients with low intensity focused ultrasound neuromodulation for drug resistant epilepsy using the NaviFUS system.  

A second clinical trial in Taiwan is treating patients with drug resistant epilepsy with the NaviFUS system.

A clinical trial in the US is treating patients with drug resistance epilepsy with the Insightec system.  

A clinical trial in Taiwan is treating patients with drug resistance epilepsy with the Insightec system.  

A clinical trial in Australia is treating patients with drug resistant epilepsy.  

clinical trial at the Brigham and Women’s University is enrolling patients with drug resistant temporal lobe epilepsy for pulsed low intensity focused ultrasound treatments.

clinical trial at University of North Carolina is recruiting patients. The study is designed to prevent the secondary generalization from focal onset epilepsy. 

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/

Preclinical Laboratory Studies

  • MRI Compatible Optical-Driven Focus Ultrasound for Neuro-modulation (Boston University, United States)
  • MRI of Skull Heating During Focused Ultrasound Neurosurgery (University of Virginia – Charlottesville, Virginia, United States)

*The Focused Ultrasound Foundation is fully or partially funding these research projects

Manufacturers

BrainSonix Corp. | Sherman Oaks, CA | www.brainsonix.com
INSIGHTEC LTD | Tirat Carmel, Israel | www.insightec.com
NaviFUS | New Taipei City, Taiwan | www.navi-fus.com

Media & Videos

With more treatment options, outcomes improve for patients with epilepsy
Mayo Clinic – November 22, 2022

Focused ultrasound may benefit some patients with epilepsy
News Medical – November 3, 2021

New tool activates deep brain neurons by combining ultrasound, genetics
WUSTL McKelvey School of Engineering News – May 27, 2021

Focused ultrasound enables precise noninvasive therapy
EurekAlert – May 4, 2021

Controlling seizures in those suffering from intractable epilepsy
Medical Xpress – December 23, 2020

Notable Papers

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

Premaratne S, Zoghi M, Antonic-Baker A, Chen Z, Chen L, Hamer R, Major B, Thomas EHX, Kwan P, O’Brien TJ, Lundstrom BN, Simpson HD. Non-invasive neurostimulation for drug-resistant epilepsy: systematic review and meta-analysis of effectiveness, safety, and optimal stimulation parameters. J Neurol. 2025 Dec 6;273(1):7. doi: 10.1007/s00415-025-13522-1. PMID: 41351627 

Gao H, Frake A, Durand DM, He B. Transcranial Focused Ultrasound Stimulation Targeting White Matter Inhibits Seizures in a Rat Model of Epilepsy. IEEE Trans Neural Syst Rehabil Eng. 2026;34:251-259. doi: 10.1109/TNSRE.2025.3644273. PMID: 41396774 

Li H, Nouraein S, Lee S, Link SS, Raisley EK, Szablowski JO. Nonsurgical Control of Seizure Threshold with Acoustically Targeted Chemogenetics. ACS Chem Neurosci. 2025 Nov 19;16(22):4327-4340. doi: 10.1021/acschemneuro.5c00404. Epub 2025 Sep 9. PMID: 40926525 

Premaratne S, Zoghi M, Antonic-Baker A, Chen Z, Chen L, Hamer R, Major B, H X Thomas E, Kwan P, J O’Brien T, N Lundstrom B, D Simpson H. Non-invasive neuromodulation for the treatment of drug-resistant epilepsy: Protocol for a systematic review and meta-analysis investigating efficacy, safety, and optimal stimulation parameters. Syst Rev. 2025 Nov 6;14(1):214. doi: 10.1186/s13643-025-02981-2. PMID: 41199344 

Besag FMC, Vasey MJ, Chin RFM. Recent Advances in the Management of Seizures in Children. Paediatr Drugs. 2025 Oct 4. doi: 10.1007/s40272-025-00710-9. PMID: 41045442 

Li H, Nouraein S, Lee S, Link SS, Raisley EK, Szablowski JO. Nonsurgical Control of Seizure Threshold with Acoustically Targeted Chemogenetics. ACS Chem Neurosci. 2025 Sep 9. doi: 10.1021/acschemneuro.5c00404. PMID: 40926525 

Agopyan-Miu A, Simmons GB, Baltuch GH. Is there a role for focused ultrasound in the treatment of refractory epilepsy? Stereotact Funct Neurosurg. 2025 Jul 7:1-28. doi: 10.1159/000547265. PMID: 40623404 

Mathon B, Navarro V, Pons T, Lecas S, Roussel D, Charpier S, Carpentier A. Ultrasound-induced blood-brain barrier opening and selenium-nanoparticle injection lower seizure activity: A mouse model of temporal lobe epilepsy. Ultrasonics. 2025 Nov;155:107734. doi: 10.1016/j.ultras.2025.107734. Epub 2025 Jun 20. PMID: 40544658 

Chu PC, Ruan WH, Huang CS, Juan YJ, Chen JH, Yu HY, Fisher RS, Liu HL. Focused ultrasound suppresses pentylenetetrazol-induced epileptiform activity in rats and alters connectivity measured by functional MRI. Sci Rep. 2025 Aug 12;15(1):29551. doi: 10.1038/s41598-025-15305-0. PMID: 40797064 

Wu PH, Chien ME, Wu YJ, Fan CH. Focused ultrasound combined with drug-loaded microbubbles suppresses ictal spikes in kainic acid-induced epileptic animals. Ultrason Sonochem. 2025 Aug 18;120:107518. doi: 10.1016/j.ultsonch.2025.107518. PMID: 40840193 

Zhong C, Yang K, Wang N, Yang L, Yang Z, Xu L, Wang J, Zhang L. Advancements in Surgical Therapies for Drug-Resistant Epilepsy: A Paradigm Shift towards Precision Care. Neurol Ther. 2025 Feb 10. doi: 10.1007/s40120-025-00710-4. PMID: 39928287 

Brinker ST, Qi W, King-Stephens D, Shoham S. Transcranial Focused Ultrasound Stimulation in Dynamic Clinical Settings: Initial Strategy in Schizophrenia and Status Epilepticus. Ultrasound Med Biol. 2025 Apr;51(4):725-726. doi: 10.1016/j.ultrasmedbio.2024.12.019. Epub 2025 Jan 23. PMID: 39848822

Ricciardi GK, Paio F, Zivelonghi C, Longhi M, Bulgarelli G, Tagliamonte M, Polloniato PM, Mantovani E, Ferlisi M, Nicolato A, Montemezzi S, Tinazzi M, Bonetti B, Sala F, Zanoni T, Tamburin S. MRgFUS disconnection surgery for hypothalamic hamartoma-related epilepsy: case report and literature review. Neurol Sci. 2024 Dec 28. doi: 10.1007/s10072-024-07946-2. PMID: 39730953 

Soltani Khaboushan A, Zafari R, Sabahi M, Khorasanizadeh M, Dabbagh Ohadi MA, Flouty O, Ranjan M, Slavin KV. Focused ultrasound for treatment of epilepsy: a systematic review and meta-analysis of preclinical and clinical studies. Neurosurg Rev. 2024 Nov 10;47(1):839. doi: 10.1007/s10143-024-03078-5. PMID: 39521750 

Baumgartner ME, Qiu L, Philipp LR, Galligan K, Halpern C, Kennedy BC. Technological advances in pediatric epilepsy surgery. Curr Probl Pediatr Adolesc Health Care. 2024 Jul;54(7):101588. doi: 10.1016/j.cppeds.2024.101588. Epub 2024 Mar 16. PMID: 38494391 

Chu PC, Yu HY, Fisher RS, Liu HL. Neuromodulatory Focused Ultrasound for Epilepsy: Are Animal Models Useful? ACS Chem Neurosci. 2024 May 1;15(9):1728-1731. doi: 10.1021/acschemneuro.4c00198. Epub 2024 Apr 18. PMID: 38634833 

Maliia MD, Nica A, Baxter J, Corniola MV. Focused ultrasounds: What is their future in epileptology? A critical review. Rev Neurol (Paris). 2024 Apr;180(4):348-353. doi: 10.1016/j.neurol.2023.10.014. Epub 2023 Dec 12. PMID: 38092574 

Click here for additional references from PubMed.

Video courtesy of Insightec