Cerena TMS Okayed For Sale On Prescription By FDA

fajb_magnet_for_headaches_01_dec2013

 

eNeura Therapeutics’ Transcranial Magnetic Stimulator (TMS) Now Available To Migraineurs With Aura (1)

US Food and Drug Administration (FDA) has allowed the marketing and sale on prescription eNeura Therapeutics device for the treatment and management of migraines. It has proved to be beneficial in pain mitigation for those whose migraine episodes are preceded by aura. Prior to awarding of approval, the FDA studied both at pre-market data as well as results of clinical trials of the device on migraineurs with aura. (2)

The device is essentially a transcranial magnetic stimulator (TMS). The Cerena TMS is to be held against the back of the migraineur’s head and turned on by the push of a button. The device releases short pulses of magnetic waves to stimulate the occipital cortex of the migraineur’s brain which in turns either ceases pain or reduces the intensity of pain. The device does not relive any other symptom associated with migraines such as photo or sound sensitivity, nausea etc. (3)

Though classified as a low-moderate risk device, it is not to be used by those suffering from epilepsy and not more than once every 24 hours even by those who are prescribed the use of the TMS. The transcranial magnetic stimulator is not recommended for those patients who have any type of implants especially magnetic metals in the head, neck or upper body, pacemakers, deep brain stimulators etc.

Randomized controlled trials on some 201 patients showed that approximately 38% of those using the TMS device were free of any pain in two hours after administration compared to 17% of controls.

SOURCE

  1. Image Credit: The Transcranial Magnetic Stimulator by eNeura Therapeutics ; Electronicproducts.com; Web December 2013; http://www.electronicproducts.com/Passive_Components/Magnetics_Inductors_Transformers/FDA_approves_pulsating_magnetic_device_to_help_ease_headaches.aspx
  2. First device to treat migraine wins FDA approval; MedicalNewsToday.com; Web December 2013; http://www.medicalnewstoday.com/articles/270233.php
  3. FDA approves pulsating magnetic device to help ease headaches; Hearst Electronic Prodcuts; Web December 2013; http://www.electronicproducts.com/Passive_Components/Magnetics_Inductors_Transformers/FDA_approves_pulsating_magnetic_device_to_help_ease_headaches.aspx

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Brain Freeze and Migraines: A Shared Mechanism At Play

Spoon in a large dollop of ice cream after you enter the house on a warm summer day and you know you are in trouble. The brain freeze will make you repent the haste almost immediately. Same with guzzling down a chilled soda. The sensation on the upper palate almost stops you in your tracks in a very uncomfortable way. Turns out, the mechanism involved in brain freeze is also at play during any migraine episode. (1)

Change in Brain’s Blood Flow Similar in Brain Freeze and a Migraine (2)

It is believed a brain freeze is an experience brought on by other experiences that are interpreted by the brain as traumatic and are often suffered by soldiers who have been close to explosions or have had combat injuries. One link between the brain freeze and the events in the onslaught of a migraine is the way there occurs a change in the blood flow of the brain.

Researchers at the Department of Veterans Affairs New Jersey Health Care System, the National University of Ireland Galway, Harvard Medical School and the the War Related Illness and Injury Study Center of the Veterans Affairs New Jersey Health Care System have observed in the experiments conducted in their study that sudden headache seems to be triggered by an abrupt increase in blood flow in the anterior cerebral artery and disappears when this artery constricts.

In the study the researchers observed 13 healthy adults whose cerebral blood flow was monitored using transcranial Doppler as they sipped ice water with a straw on their upper palate. This was done in order to have an onset of brain freeze. Next their cranial blood flow was noted using the same tool when they were made to sip water of room temperature in the same way. The volunteers were made to signal the onset and the dissipation of the brain freeze. The observations showed that one particular artery, called the anterior cerebral artery, dilated rapidly and flooded the brain with blood in conjunction to when the volunteers felt pain. Soon after this dilation occurred, the same vessel constricted as the volunteers’ pain receded.

As per the study lead Jorge Serrador of Harvard Medical School, “The brain is one of the relatively important organs in the body, and it needs to be working all the time. It’s fairly sensitive to temperature, so vasodilation might be moving warm blood inside tissue to make sure the brain stays warm. But the brain is a closed structure, so the sudden influx of blood could raise pressure and induce pain. The following vasoconstriction may be a way to bring pressure down in the brain before it reaches dangerous levels.” (3)

Serrador has pointed that similar changes in blood flow is noticeable in those who have migraines during a migraine attack or in those with post-traumatic headaches. This provides avenues for pharmaceutical companies to work on a drug that targets on areas based on the finding of this study, thus bringing about a change in the course of migraines and certain headache types.

SOURCES:

  1. Changes in Brain’s Blood Flow Could Cause ‘Brain Freeze’; Science Daily News; April 2012; http://www.sciencedaily.com/releases/2012/04/120422231742.htm
  2. Image by Victor Habbick; Freedigitalphotos.net; April 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=4036
  3. Changes in Brain’s Blood Flow Could Cause ‘Brain Freeze’; American Physiological Society – Onsite Newsroom; April 2012; http://www.the-aps.org/mm/hp/Audiences/Public-Press/For-the-Press/releases/12/15.html

 

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