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Anxiety

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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.

Focused Ultrasound Therapy

Focused ultrasound is a therapeutic technology that could transform the quality of life and decrease the cost of care for patients with anxiety. This novel technology focuses beams of ultrasound energy precisely and accurately on targets 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 use low intensity neuromodulation which can be aimed at various locations including the amygdala or the ventral striatum, with the goal of modulating the impact of stimulations to reduce anxiety. A second approach is to use high frequency energy to create a lesion in the anterior nucleus.

The primary options for treatment of anxiety include medication, but it is often limited in its success.  

Advantages
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as like surgical wound healing or infection – at a lower cost. Focused ultrasound can reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

A clinical trial in California is using low frequency neuromodulation to treat anxiety.

Another clinical trial in California is recruiting patient to treat with low frequency neuromodulation to reduce anxiety.  

A clinical trial in Texas is using low frequency neuromodulation to treat the combination of anxiety and obsessive compulsive disorder.

A clinical trial in Rhode Island is using low frequency neuromodulation to treat the combination of anxiety and depression.

A clinical trial in Virginia is recruiting by invitation , using low frequency neuromodulation to treat anxiety. 

A clinical trial is recruiting patients in Ohio that will use high frequency ablation to treat focal seizure propagation and anxiety.

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 anxiety is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

de Souza DN, Seas A, Blethen K, Feigal J, Shah BR, Grant GA, Harward SC. Focused ultrasound as an emerging therapy for neuropsychiatric disease: Historical perspectives and a review of current clinical data. Psychiatry Clin Neurosci. 2025 Feb 12. doi: 10.1111/pcn.13799. PMID: 39936841 

Shi Y, Wu W. Advances in transcranial focused ultrasound neuromodulation for mental disorders. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jan 10;136:111244. doi: 10.1016/j.pnpbp.2024.111244. Epub 2025 Jan 3. PMID: 39756638 

Ziebell P, Rodrigues J, Forster A, Sanguinetti JL, Allen JJ, Hewig J. Inhibition of midfrontal theta with transcranial ultrasound explains greater approach versus withdrawal behavior in humans. Brain Stimul. 2023 Aug 21;16(5):1278-1288. doi: 10.1016/j.brs.2023.08.011. PMID: 37611659

Becker CR, Milad MR. Contemporary Approaches Toward Neuromodulation of Fear Extinction and Its Underlying Neural Circuits. Curr Top Behav Neurosci. 2023 Sep 2. doi: 10.1007/7854_2023_442. Online ahead of print. PMID: 37658219

Legon W, Strohman A, In A, Stebbins K, Payne B. Non-invasive neuromodulation of sub-regions of the human insula differentially affect pain processing and heart-rate variability. bioRxiv. 2023 May 5:2023.05.05.539593. doi: 10.1101/2023.05.05.539593. Preprint. PMID: 37205396

Chu PC, Huang CS, Ing SZ, Yu HY, Fisher RS, Liu HL. Pulsed Focused Ultrasound Reduces Hippocampal Volume Loss and Improves Behavioral Performance in the Kainic Acid Rat Model of Epilepsy. Neurotherapeutics. 2023 Mar;20(2):502-517. doi: 10.1007/s13311-023-01363-7. Epub 2023 Mar 14. PMID: 36917440 

Zhang X, Xu W, Sang G, Yu D, Shi Q. A measure for perioperative anxiety symptoms in patients with FUAS – treated uterine fibroids: development and validation. Int J Hyperthermia. 2022;39(1):525-529. doi: 10.1080/02656736.2022.2051612.PMID: 35300541 

Click here for additional references from PubMed.