Focused ultrasound is a therapeutic technology that could transform the quality of life and decrease the cost of care for patients with Leigh syndrome This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces a therapeutic effect where the target area blood-brain barrier (BBB) is temporarily opened, and therapeutic agents in the blood stream have the opportunity to get access to the brain and improve the neurodegeneration that has been occurring.  

For certain patients, focused ultrasound could provide a noninvasive and more effective alternative to existing care. While significant work has been accomplished, there is still much to do be done before this technology will be widely available.

Advantages 

• Focused ultrasound is noninvasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of Leigh syndrome.  

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/.  

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for Leigh syndrome is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Faideau M, Clément R, Rigollet S, Benegiamo G, Cresson C, Blot B, Reynaud-Dulaurier R, Yjjou S, Aprahamian F, Durand S, Delalande A, Barbier EL, Stupar V, Auwerx J, Decressac M. Ultrasound-assisted gene therapy mitigates Leigh syndrome pathology. Brain. 2026 Jan 23:awag026. doi: 10.1093/brain/awag026. Epub ahead of print. PMID: 41572892. 

Click here for additional references from PubMed.   

Focused ultrasound is a therapeutic technology that could transform the quality of life and decrease the cost of care for patients with restless leg syndrome. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces neuronavigation to the targeted area in the brain which over time reduced the symptoms in the patient.  

The primary option for treatment of restless leg syndrome is medication. For certain patients, focused ultrasound could provide a noninvasive and more effective alternative to medications. While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

Advantages 

• Focused ultrasound is noninvasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of restless leg syndrome.  

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/.  

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for restless leg syndrome is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Mitsi E, Kattou P and Kondratev S (2026) Case Report: A novel use of Transcranial Pulse Stimulation in refractory Restless Legs Syndrome. Front. Hum. Neurosci. 20:1723992. doi: 10.3389/fnhum.2026.1723992 

Click here for additional references from PubMed.   

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with fibromyalgia. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 

Where the beams converge, focused ultrasound produces neuromodulation effects that appear to be helpful in this complicated disease. The target is the cingulate cortex.  

The primary options for treatment of fibromyalgia are limited, and many patients are stuck trying to use symptomatic medications to try to outlast the disease.    

For certain patients, focused ultrasound could provide a valuable addition to the care for this difficult disease.  

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time there are several clinical trials for complex regional pain syndromes, but only the ones that specifically target fibromyalgia are listed below.

There is a clinical trial in Utah using focused ultrasound neuromodulation targeting the cingulate cortex to treat fibromyalgia.

There is a clinical trial for fibromyalgia (and other painful conditions) that is underway at Virginia Tech.   

There is a clinical trial for fibromyalgia (and other painful conditions) that is underway in Beijing, China.   

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/.  

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for fibromyalgia is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Zhang JH, Liang J, Yang ZW. Non-invasive brain stimulation for fibromyalgia: current trends and future perspectives Front Neurosci. 2023 Oct 19:17:1288765. doi: 10.3389/fnins.2023.1288765. eCollection 2023. PMID: 37928733 PMCID: PMC10620708 DOI: 10.3389/fnins.2023.1288765 

Click here for additional references from PubMed.

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with peripheral neuropathy. This novel technology focuses beams of ultrasound energy precisely and accurately on the nerves in the body without damaging surrounding normal tissue. 

How it Works 

Where the beams converge, low intensity focused ultrasound was use to target the tibial and peroneal nerves in the calf muscles to cause reduced pain from the treated extremities.  

The primary options for treatment of peripheral neuropathy include medication and at times invasive surgery.  

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, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of peripheral neuropathy, but it may be included in some of the studies being done for neuropathic pain.  

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/.  

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for peripheral neuropathy is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Shih LC. Essential Tremor. Continuum (Minneap Minn). 2025 Aug;31(4):979-999. doi: 10.1212/cont.0000000000001605. Epub 2025 Aug 1.PMID: 40748121  

Hosseinzadeh D, Barary M, Javanian M, Alizadeh Khatir A, Ebrahimpour S. Commentary on “Explore the Effect of Low-Intensity Focused Ultrasound on Pain Relief in Patients With Diabetic Peripheral Neuropathy”. J Ultrasound Med. 2025 Jun 24. doi: 10.1002/jum.16753. Online ahead of print. PMID: 40552684 No abstract available. 

Zhang X, Wang Y, Peng W, Liu Z, Liu L, Han X, Li C, Li F, Ge Q. Explore the Effect of Low-Intensity Focused Ultrasound on Pain Relief in Patients With Diabetic Peripheral Neuropathy: A Pilot Randomized Trial. J Ultrasound Med. 2025 May 5. doi: 10.1002/jum.16716. Online ahead of print.PMID: 40322947 

Deer TR, Pope JE, Petersen EA, Abdallah RT, Amirdelfan K, Azeem N, Bansal V, Barkoh K, Chapman KB, Denis DR, Dorsi MJ, Escobar A, Falowski SM, Garcia RA, Hagedorn JM, Heros RD, James WS, Kalia H, Lansford T, Malinowski MN, Manzi SM, Mehta P, Moghim RZ, Moore GA, Motivala SL, Navalgund YA, Patel RG, Pilitsis JG, Schatman ME, Shumsky PM, Strand NH, Tomycz ND, Yue JJ, Sayed D. An Evidence-Based Consensus for the Use of Neurostimulation for the Treatment of Non-Surgical Low Back Pain: The NEURON Group. J Pain Res. 2025 Mar 14;18:1247-1274. doi: 10.2147/JPR.S500342. eCollection 2025.PMID: 40104824  

Jackson LM, Kaufmann TJ, Lehman VT, Lee KH, Miller KJ, Hassan A, Klassen BT. Clinical Characteristics of Patients with Gait Instability after MR-Guided Focused Ultrasound Thalamotomy. Tremor Other Hyperkinet Mov (N Y). 2021 Oct 21;11:41. doi: 10.5334/tohm.643. eCollection 2021.PMID: 34721943  

Click here for additional references from PubMed.   

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients suffering from poisoning. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 

Where the beams converge, focused ultrasound can produce temporary opening of the blood brain barrier (BBB), which prevents the accessing of the brain by therapeutic agents that can help with organic phosphates and warfare poisons. A preclinical study showed that the use of oximes in treatment of a supra-lethal dose of venomous agent X (a very toxic nerve gas) resulted in enhanced recovery from the treatment. While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

The primary options for treatment of poisons involves the understanding of the type of the poison, and the ability to intervene in a timely manner.   

For certain patients, focused ultrasound could provide a non-invasive alternative option to patients who inadvertently are exposed to pesticides or to warfare poisons.  

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of organic poisons.  

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/.  

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for organic poisons is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Lépinard L, Leterrier S, Jourdain L, Turri L, Belkebir A, Knoertzer J, Champault A, Bel R, Selingue E, Mériaux S, Larrat B, Tournier N, Bo GD, Thibault K, Novell A. Corrigendum to “Enhancing oxime efficacy into brain using ultrasound to counteract nerve agent exposure” [Biomed. Pharmacother. 187 (2025) 118120]. Biomed Pharmacother. 2025 Jul;188:118233. doi: 10.1016/j.biopha.2025.118233. Epub 2025 Jun 11. PMID: 40500609  

Lucie L, Sarah L, Laurène J, Louise T, Assia B, Julie K, Alexandre C, Rosalie B, Erwan S, Sébastien M, Benoit L, Nicolas T, Grégory DB, Karine T, Anthony N. Enhancing oxime efficacy into brain using ultrasound to counteract nerve agent exposure. Biomed Pharmacother. 2025 Jun;187:118120. doi: 10.1016/j.biopha.2025.118120. Epub 2025 May 9. PMID: 40347846 

Kuca K, Valle da Silva JA, Nepovimova E, Pham NL, Wu W, Valis M, Wu Q, França TCC. Pralidoxime-like reactivator with increased lipophilicity – Molecular modeling and in vitro study. Chem Biol Interact. 2023 Nov 1;385:110734. doi: 10.1016/j.cbi.2023.110734. Epub 2023 Oct 1. PMID: 37788753 

Andrýs R, Klusoňová A, Lísa M, Kassa J, Karasová JŽ. Effect of Oxime Encapsulation on Acetylcholinesterase Reactivation: Pharmacokinetic Study of the Asoxime-Cucurbit[7]uril Complex in Mice Using Hydrophilic Interaction Liquid Chromatography-Mass Spectrometry. Mol Pharm. 2021 Jun 7;18(6):2416-2427. doi: 10.1021/acs.molpharmaceut.1c00257. Epub 2021 May 21. PMID: 34019427 

Click here for additional references from PubMed.   

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with nerve injury requiring grafting. This novel technology focuses beams of ultrasound energy precisely and accurately on the body without damaging surrounding normal tissue. 

How it Works 

Where the beams converge, focused ultrasound treatment of the donor graft before it is harvested yields a pre-degenerated state which in preclinical models has a significantly higher graft survival coupled with a higher muscle strength than donor sites with no focused ultrasound treatment. While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

The primary options for treatment of nerve injury requiring grafting are open surgery, but the addition of higher graft survival rates and enhanced muscle strength would be welcome additions to conventional medicine.  

For certain patients, focused ultrasound could provide significant advantages, with little additional risk.  

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of nerve injury requiring grafting.  

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/.  

Regulatory Approval and Reimbursement 

Focused ultrasound treatment for nerve injury requiring grafting is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers

Chu TH, Lasaleta N, Li S, McConnachie A, Molina L, Alzahrani S, Curiel L, Pichardo S, Midha R. Predegenerating donor nerve for grafting using focused ultrasound neurotomy. Sci Rep. 2025 May 4;15(1):15581. doi: 10.1038/s41598-025-00316-8. PMID: 40320399  

Kim SH, Cho BK, Choi SM, Kim SH. Clinical and Radiologic Outcomes Following Autologous Osteochondral Transplantation for Lateral Osteochondral Lesions of the Talus. Foot Ankle Int. 2025 Feb;46(2):182-191. doi: 10.1177/10711007241308576. Epub 2025 Jan 18. PMID: 39825769 

Click here for additional references from PubMed.   

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with hypoxic injury due to prematurity. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound enhance the diffusion of the sodium butyrate covered nanoparticles that have shown in preclinical models to dramatically reduce the infarct size that comes from the hypoxic state.  While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

The primary options for treatment of HIEP are limited, and typically the infarction size is not able to be controlled with current treatment.  

For certain patients, focused ultrasound could provide a non-invasive alternative to current care that may decrease the morbidity of this difficult situation.  

Advantages

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of HIEP.  

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/.  

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for HIEP is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Zhao J, Zhang J, Hou L, Yang C, Jiang L, Liang D. Nanoparticle-mediated sodium butyrate delivery for repairing hypoxic-ischemic brain injury in premature infants. Mater Today Bio. 2025 Mar 14;32:101665. doi: 10.1016/j.mtbio.2025.101665. eCollection 2025 Jun. PMID: 40230649 

Click here for additional references from PubMed.  

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with Tourette Syndrome. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated. One is to treat the target with thermal ablation. This has been reported by the Shanghai International Medical Center. Another possible approach is to target the thalamus with low intensity focused ultrasound. There is currently no FDA or equivalent international approval for this treatment, so it is an item being evaluated in clinical trials.  

The primary options for treatment of Tourette Syndrome are very limited.  For certain patients, focused ultrasound could provide an effective addition to conventional therapy. While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of Tourette Syndrome.  

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/. 

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for Tourette Syndrome is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Martin E, Roberts M, Grigoras IF, Wright O, Nandi T, Rieger SW, Campbell J, den Boer T, Cox BT, Stagg CJ, Treeby BE. Ultrasound system for precise neuromodulation of human deep brain circuits. Nat Commun. 2025 Sep 5;16(1):8024. doi: 10.1038/s41467-025-63020-1. PMID: 40913042  

Vogt L, Quiroz V, Ebrahimi-Fakhari D. Emerging therapies for childhood-onset movement disorders. Curr Opin Pediatr. 2024 Jun 1;36(3):331-341. doi: 10.1097/MOP.0000000000001354. Epub 2024 Apr 4. PMID: 38655812 

Reddy A, Hosseini MR, Patel A, Sharaf R, Reddy V, Tabarestani A, Lucke-Wold B. Deep brain stimulation, lesioning, focused ultrasound: update on utility. AIMS Neurosci. 2023 Apr 26;10(2):87-108. doi: 10.3934/Neuroscience.2023007. eCollection 2023. PMID: 37426775  

Click here for additional references from PubMed.   

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with chronic pain. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated. Some clinical trials involve the use of high intensity focused ultrasound to ablate nerves that are responsible for chronic pain, and other sites are using a neuromodulatory approach to impact the target. There is also a combination of other co-morbidities that are related to the impact of pain, such as alcohol or substance abuse that can also have an impact on the disease. Please also see “Pain, Neuropathic” for additional discussions that may also be relevant. 

The primary options for treatment of highly variable and can include potentially addictive medication and possible surgery.  

For certain patients, focused ultrasound could provide an effective and non-invasive alternative to current therapy with less risk of complications and lower cost.  

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

This clinical trial at Virginia Tech is using low intensity focused ultrasound on normal patients to see their impact to painful stimuli.  

A second clinical trial at Virginia Tech is using low intensity focused ultrasound on normal adults to see the impact on painful stimuli. This project is recruiting patients with an invitation only format.  

A clinical trial at Virginia Tech is using low intensity focused ultrasound to treat patients who have complex regional pain syndromes or fibromyalgia.  

A clinical trial at Virginia Tech is treating complex patients who have chronic pain, anxiety and craving.  

A clinical trial at Virginia Tech is treating patients who have chronic pain and alcohol abuse.  

This clinical trial at Virginia Tech is treating patients with a chronic pain diagnosis with low intensity focused ultrasound. This project is recruiting patients with an invitational only format.   

A clinical trial at the University of Utah is treating patients with focused ultrasound who have chronic neurological pain.  

A clinical trial in Washington, DC is treating complex patients who have chronic back pain, opioid use disorder and anxiety.  

A clinical trial in Massachusetts is treating chronic pain patients who have carpal tunnel syndrome.   

A clinical trial in Taiwan is treating patients with chronic facet arthritis and back pain.  

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/. 

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for chronic pain is not yet approved by regulatory bodies or covered by medical insurance companies. 

Notable Papers 

Kim MG, Yeh CY, Gao H, Lee K, Gupta K, He B. Low-intensity transcranial focused ultrasound engages parvalbumin-positive GABAergic interneurons in a humanized mouse model of chronic pain: From electrophysiology to cellular investigation. J Neural Eng. 2026 Mar 19. doi: 10.1088/1741-2552/ae54cd. PMID: 41855581 

Li X, Lin L, Zhu M, Li X, Yu J, Lu D, Li S, Shen Y, Xiong B, Zhao C, Zhou B, Yin H, Xu H, Guan X. Low-intensity focused ultrasound-activated piezoelectric gel bandage for diabetic wound repair and neuropathic pain relief. Nat Commun. 2026 Mar 19. doi: 10.1038/s41467-026-70771-y. PMID: 41857055 

Paio F, Bulgarelli G, Tagliamonte M, Bovi T, Longhi M, Nicolato A, Sala F, Petralia B, Bonetti B, Tinazzi M, Ricciardi GK, Tamburin S. How do we FUS? Peri-procedural management of magnetic resonance-guided focused ultrasound: An EMEA regional survey. Parkinsonism Relat Disord. 2026 Mar 12;146:108284. doi: 10.1016/j.parkreldis.2026.108284. PMID: 41844501 

De Schlichting E, Huang Y, Jones RM, Meng Y, Cao X, Baskaran A, Hynynen K, Hamani C, Lipsman N, Goubran M, Davidson B. Focused ultrasound capsulotomy: predicting the probability of successful lesioning based on skull morphology. J Neurosurg. 2026 Jan 1;144(1):94-103. doi: 10.3171/2025.6.JNS2588. PMID: 41072044 

McKenzie A, Dombrower R, McKenzie S, Theeraphapphong N, Abd-Elsayed A. Emerging Nonpharmacologic Analgesic Technologies in Anesthesia: Mechanisms, Evidence, and Future Directions for Pharmacologic Alternatives. Biomedicines. 2026 Jan 20;14(1):225. doi: 10.3390/biomedicines14010225. PMID: 41595760 

Slavin KV. Commentary: A Scoping Review of Focused Ultrasound- Blood-Brain Barrier Opening for Treatment of Chronic Pain. Neurosurgery. 2026 Feb 1;98(2):e23-e24. doi: 10.1227/neu.0000000000003840. Epub 2025 Oct 31. PMID: 41171002 

Strohman A, Legon W. Neuromodulation of the Cingulate Cortex for Pain. Neuroscientist. 2025 Dec;31(6):611-629. doi: 10.1177/10738584251337652. Epub 2025 Jun 26. PMID: 40574510 

Davidson B, Schmidt FA, Bichsel O, Hajiabadi MM, Lozano AM. Transcranial Focused Ultrasound: A Transformative Tool for Intracranial Ablation, Drug Delivery, and Neuromodulation. IEEE Rev Biomed Eng. 2025 Nov 11;PP. doi: 10.1109/RBME.2025.3624970. PMID: 41217925 

Chen Y, Sun Y, Li X, Lin Y, He P, Wang Q. Immediate efficacy of low-intensity focused ultrasound versus planar ultrasound in patients with myofascial pain syndrome of upper trapezius: a randomized controlled clinical trial. BMC Musculoskelet Disord. 2025 Jul 31;26(1):738. doi: 10.1186/s12891-025-09017-9. PMID: 40745538 

Gillespie E, Bouchal E, Elliott T, Pilitsis JG. A Scoping Review of Focused Ultrasound- Blood-Brain Barrier Opening for Treatment of Chronic Pain. Neurosurgery. 2025 Jul 17. doi: 10.1227/neu.0000000000003595. PMID: 40673684 

Shi Y, Wu W. Advancements and prospects of transcranial focused ultrasound in pain neuromodulation. Pain. 2025 Feb 18. doi: 10.1097/j.pain.0000000000003556. PMID: 39968911

Kim MG, Yeh CY, Yu K, Li Z, Gupta K, He B. Analgesic effect of simultaneously targeting multiple pain processing brain circuits in an aged humanized mouse model of chronic pain by transcranial focused ultrasound. APL Bioeng. 2025 Feb 19;9(1):016108. doi: 10.1063/5.0236108. eCollection 2025 Mar. PMID: 39990925 

Lin YT, Chen KT, Hsu CC, Liu HL, Jiang YT, Ho CW, Chen JC, Li HY, Weng CC, Hsu PH. Stimulation of dorsal root ganglion with low-intensity focused ultrasound ameliorates pain responses through the GABA inhibitory pathway. Life Sci. 2025 Jan 15;361:123323. doi: 10.1016/j.lfs.2024.123323. Epub 2024 Dec 19. PMID: 39709165 

Trujillo FA, Thomas HA, Berwal D, Rajulapati N, DiMarzio M, Pilitsis JG. Hip and waist circumference correlations with demographic factors and pain intensity in patients with chronic pain. Trujillo FA, Thomas HA, Berwal D, Rajulapati N, DiMarzio M, Pilitsis JG.Pain Manag. 2024;14(8):421-429. doi: 10.1080/17581869.2024.2403961. Epub 2024 Oct 3. PMID: 39363634 

Colasurdo M, Ahmed AK, Gandhi D. MR-guided Focused Ultrasound Thalamotomy for Chronic Pain. Magn Reson Imaging Clin N Am. 2024 Nov;32(4):661-672. doi: 10.1016/j.mric.2024.04.005. Epub 2024 Jul 25. PMID: 39322355  

Click here for additional references from PubMed.   

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with insomnia. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated. A report by Shanghai International Medical Center using high intensity thermal ablation to treat this disease. Low intensity focused ultrasound directed to those recovering from opioid use disorder has aided in their recovery of normal sleep. A preclinical study has shown that stimulation can excite the local GABA pathway to override the simultaneous increase in the dopaminergic pathway. There is also some use of neuromodulation of the medial prefrontal cortex to aid in this treatment. There is no FDA or equivalent international regulatory approval for the use of this treatment, so we will continue to follow the clinical trials for the development of this technology.  

The primary options for treatment of insomnia include medication and with less often use of invasive surgery. For certain patients, focused ultrasound could provide a non-invasive alternative to conventional treatments.  

While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

A clinical trial involving a wearable system for REM sleep restoration is being evaluated for patients with sleep disturbances in Austin, Texas. 

A clinical trial in Egypt is using focused ultrasound to treat patients for insomnia.  

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/. 

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement  

Focused ultrasound treatment for insomnia is not yet approved by regulatory bodies or covered by medical insurance companies.  

Notable Papers 

Jeswani HK, Maheshwari S. Neuromodulation in chronic insomnia: Targeting the dorsal raphe nucleus. Sleep Med. 2025 Oct 18;136:106876. doi: 10.1016/j.sleep.2025.106876. PMID: 41124978 

Meads KL, Huettner S, Amata D, Johnson H, Devine JK, Warnakulasuriya S, Murphy KR, Good CH. Feasibility and acceptability of wearing a neuromodulation device at night in individuals in recovery from opioid use disorder. Front Psychiatry. 2024 Nov 29;15:1481795. doi: 10.3389/fpsyt.2024.1481795. eCollection 2024. PMID: 39676914  

Kim YG, Kim SE, Lee J, Hwang S, Yoo SS, Lee HW. Neuromodulation Using Transcranial Focused Ultrasound on the Bilateral Medial Prefrontal Cortex. J Clin Med. 2022 Jun 30;11(13):3809. doi: 10.3390/jcm11133809. PMID: 35807094  

Click here for additional references from PubMed.