Home Diseases and Conditions Headaches

Headaches

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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 has been researched in clinical trials. However, at this time, we are not aware of any open 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 different types of headaches, including chronic migraine headaches. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.

How It Works
Where the beams converge, focused ultrasound can cause several different effects that can be helpful.

In clinical use, there has been a single case report where thermal ablation of the nerve pathways have been ablated with good success.

In preclinical models, use of FUS neuromodulation of the occipital nerves that has reduced the severity of headaches.

While significant preclinical 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 headaches include medication, many of which have side effects or are only partly effective. Possible advantages are:

  • 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 treatment of headaches.

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

Notable Papers

Yoon BC, Coetzee JP, Kang X, Brar R, Timmerman M, Harris O, Madrigal E, Adamson MM. Low-intensity focused ultrasound (LIFU) for the treatment of post-traumatic headache (PTH) in veterans: A feasibility study. Brain Stimul. 2024 Nov 18;17(6):1290-1292. doi: 10.1016/j.brs.2024.11.007. PMID: 39566597 

Magara AE, Gallay MN, Moser D, Jeanmonod D. Complete resolution of chronic cluster headache following central lateral thalamotomy using incisionless MRI-guided focused ultrasound with 6 years of follow-up: illustrative case. J Neurosurg Case Lessons. 2022 Nov 28;4(22):CASE22259. doi: 10.3171/CASE22259. Print 2022 Nov 28.  

Franzini A, Moosa S, D’Ammando A, Bono B, Scheitler-Ring K, Ferroli P, Messina G, Prada F, Franzini A. The neurosurgical treatment of craniofacial pain syndromes: current surgical indications and techniques. Neurol Sci. 2019 May;40(Suppl 1):159-168. doi: 10.1007/s10072-019-03789-4.

Chiou JY, Abd-Elrehim T, Lin CC, Chen GS. Feasibility study of greater occipital nerve blocks by focused ultrasound – an animal study. J Neural Eng. 2020 Nov 4;17(5):056030. doi: 10.1088/1741-2552/abb14d.

Click here for additional references from PubMed.