Home Diseases and Conditions Epilepsy

Epilepsy

Last Updated:
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.

Focused Ultrasound Therapy

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.

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 or complement to conventional therapy, with several advantages.

  • Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.
  • It can reach the desired target without damaging surrounding tissue.
  • Focused ultrasound does not use any ionizing radiation.
  • It can be repeated, if necessary.

Clinical Trials

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.  

A 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.

A 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

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.

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.

Notable Papers

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

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 

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