Headache

Updated 07 December 2015

FDA approves new migraine device

The FDA has approved a device to treat migraine pain when the headache is preceded by a so-called aura.

0
The first device to treat migraine pain when the headache is preceded by an often-visual disturbance called an aura has been approved by the US Food and Drug Administration.

The Cerena Transcranial Magnetic Stimulator (TMS) is held to the back of the head and the user presses a button to release a pulse of magnetic energy. This stimulates the brain's occipital cortex, which may reduce or eliminate migraine-associated pain, the FDA said in a news release.

The device was tested in a clinical trial of 201 people with mostly moderate-to-strong migraines.

Nearly 38% of people with migraine pain were pain-free two hours after use, compared with 17% of people who didn't use the device, the FDA said. The device was not evaluated among people with headaches other than those with migraines preceded by aura, the agency said.

Among the rare side effects reported were sinusitis and dizziness. The device shouldn't be used by people with metals in their head, neck or upper body, or by people with an implanted medical device such as a pacemaker or deep brain stimulator, the FDA said.

The Cerena TMS is produced by eNeura Therapeutics, based in Sunnyvale, California.

More information

The FDA has more about this approval.

Copyright © 2016 HealthDay. All rights reserved.

 

Read Health24’s Comments Policy

Comment on this story
0 comments
Comments have been closed for this article.

Ask the Expert

Headache expert

Dr Elliot Shevel is a South African migraine surgery pioneer and the founder and medical director of The Headache Clinic in Johannesburg, Durban and Cape Town, South Africa. The Headache Clinic is a multidisciplinary practice dedicated to the diagnosis and treatment of Primary Headaches and Migraines. Dr Shevel is also the main author of all scientific publications generated by his team. He recently won a high level science debate in which he was able to prove that the current migraine diagnosis and classification is not based on data. Tertiary Education - Dr Shevel holds both Dental and Medical degrees, and practises as a specialist Maxillo-facial and Oral Surgeon. Follow the Headache Clinic on Twitter@HeadacheClinic.

Still have a question?

Get free advice from our panel of experts

The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.

* You must accept our condition

Forum Rules