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 cognitive impairment, which is commonly also called dementia. (Please note that Alzheimer’s disease is a specific type of cognitive impairment, and it is covered under Alzheimer’s disease). 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 several therapeutic effects that are being evaluated. One mechanism is the temporary loosening of the blood-brain barrier (BBB), which may improve the ability of toxic materials to exit and allow cognitive impairment to be treated without surgery. Opening the BBB can also enhance the delivery of therapeutic intravenous exosomes. Another mechanism is to use focused ultrasound to stimulate portions of the brain to have higher activity. While significant work has been accomplished, there is still much to be done before this technology will be widely available.
Advantages
The primary options for treatment of cognitive impairment includes medication, but this is of limited effectiveness.
For certain patients, focused ultrasound might provide a more effective alternative to current treatments. 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 looking to see if transcranial ultrasound stimulation improves neurologic and cognitive outcomes in patients treated with neurodegenerative diseases.
A clinical trial in Michigan is evaluating the impact of deep brain stimulation during sedation has on cognitive ability.
A clinical trial in South Carolina is using early cognitive impairment with focused ultrasound. This trial is recruiting patients on an invitation only basis.
A clinical trial for patients with mild cognitive impairment or early Alzheimer’s disease is recruiting patients in West Virginia.
A clinical trial is treating patients with neurodegenerative cognitive impairment in Los Angeles, California. This study is only recruiting patients by invitation.
A clinical trial in Florida is using the Storz device to evaluate its effectiveness on patients with mild Alzheimer’s disease.
A clinical trial at the University of Hong Kong is enrolling patients by invitation who have cognitive decline for transcranial pulse stimulation.
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/.
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Find a Treatment Site
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Regulatory Approval and Reimbursement
Focused ultrasound treatment for cognitive impairment is not yet approved by regulatory bodies or covered by medical insurance companies.
Notable Papers
Suggested Reading: Focused Ultrasound: Transforming treatment of Neurodegenerative Diseases August 2022
Jung J, Atkinson-Clement C, Kaiser M, Lambon Ralph MA. Transcranial focused ultrasound stimulation enhances semantic memory by modulating brain morphology, neurochemistry and neural dynamics. Nat Commun. 2026 Feb 16. doi: 10.1038/s41467-026-69579-7. PMID: 41698912
Polte S, Klingmann L, Seßmann A, Schwichtenberg S, Herrmann CS, Witt K, Roheger M. Neuromodulatory Effects of Transcranial Pulse Stimulation (TPS) in Neurological and Psychiatric Disorders-A Systematic Review and Meta-Analysis. Neurol Int. 2025 Nov 18;17(11):188. doi: 10.3390/neurolint17110188. PMID: 41295447
Strohman A, Isaac G, Payne B, Verdonk C, Khalsa SS, Legon W. Low-intensity focused ultrasound to the insula differentially modulates the heartbeat-evoked potential: A proof-of-concept study. Clin Neurophysiol. 2024 Nov;167:267-281. doi: 10.1016/j.clinph.2024.09.006. Epub 2024 Sep 19. PMID: 39366795
Yoo SS, Kim E, Kowsari K, Van Reet J, Kim HC, Yoon K. Non-invasive enhancement of intracortical solute clearance using transcranial focused ultrasound. Sci Rep. 2023 Jul 31;13(1):12339. doi: 10.1038/s41598-023-39640-2. PMID: 37524783
Kuo YY, Chen WT, Lin GB, Chen YM, Liu HH, Chao CY. Thermal cycling-hyperthermia ameliorates Aβ25-35-induced cognitive impairment in C57BL/6 mice. Neurosci Lett. 2023 Jun 12;810:137337. doi: 10.1016/j.neulet.2023.137337. PMID: 37315732
Kim E, Van Reet J, Kim HC, Kowsari K, Yoo SS. High Incidence of Intracerebral Hemorrhaging Associated with the Application of Low-Intensity Focused Ultrasound Following Acute Cerebrovascular Injury by Intracortical Injection. Pharmaceutics. 2022 Oct 6;14(10):2120. doi: 10.3390/pharmaceutics14102120.
Pineda-Pardo JA, Gasca-Salas C, Fernández-Rodríguez B, Rodríguez-Rojas R, Del Álamo M, Obeso I, Hernández-Fernández F, Trompeta C, Martínez-Fernández R, Matarazzo M, Mata-Marín D, Guida P, Duque A, Albillo D, Plaza de Las Heras I, Montero JI, Foffani G, Toltsis G, Rachmilevitch I, Blesa J, Obeso JA. Striatal Blood-Brain Barrier Opening in Parkinson’s Disease Dementia: A Pilot Exploratory Study. Mov Disord. 2022 Jun 28. doi: 10.1002/mds.29134.
Gasca-Salas C, Fernández-Rodríguez B, Pineda-Pardo JA, Rodríguez-Rojas R, Obeso I, Hernández-Fernández F, Del Álamo M, Mata D, Guida P, Ordás-Bandera C, Montero-Roblas JI, Martínez-Fernández R, Foffani G, Rachmilevitch I, Obeso JA. Blood-brain barrier opening with focused ultrasound in Parkinson’s disease dementia. Nat Commun. 2021 Feb 3;12(1):779. doi: 10.1038/s41467-021-21022-9.
Click here for additional references from PubMed.