An innovative way to cope with chronic migraine

CONTRIBUTED GRAPHIC

An experimental medical device that's implanted under the skin of the scalp stimulates nerves in the brain linked to migraine. The has been found to cut days with migraine headaches per month in half.

Migraine headaches are no fun.

Arguably the most severe type of headache, migraines consist of throbbing pain usually in one pinpoint spot in your head that is accompanied by nausea and sometimes disturbed vision. 

Dr. Leo Kapural, a pain physician at Queen City Clinical Research, is leading a national study testing a new method of migraine treatment in which small implant placed under the skin of the scalp gently stimulates nerves in the brain linked to migraine.

“I’ve been doing neuromodulation for treatment of various chronic pains for the last 26 years,” Kapural said. “This really neat new approach to how to control pain from severe migraines is in its trial period. With neuromodulation it is important to emphasize that we are stimulating peripheral nerves that have multiple electrodes on them so we can properly capture the nerve when we put the implant under the skin.”

The Food and Drug Administration is overseeing the trials and if successful, will go about approving it for further implementation. 

“The FDA has to approve the device,” Kapural said. “This is research and we don’t have any claims unless the research shows that we were correct in our hypothesis. So, the improvement of the pain sources, improvement in headache days and so on. So, it is not readily available for the public yet. People can however sign up for the trials if they have severe migraine headaches that aren’t otherwise responsive to medical management.”

Migraine sources can be linked to a lot of things, some neuronal and some vascular.

“We know that the migraines have genetic predisposition,” Kapural said. “Number two, there is something called CSD that has been very popular for the last many years, and this is what is called cortical spreading depression. This is sort of like a wave of electrical activity that can cross the cerebral cortex, and it can actually contribute to this formation of the aura before migraine, severe pain comes along, and we know that this is trigeminal nerve activation. This is the trigeminal nerve system that controls the front and the occipital complex controls back. That’s why we stimulate on both sides, so that both of those get activated.”

The study’s early results found the implant can cut monthly migraine days in half. 

Charlotte is among the places where people can participate in the trial. Once the hypothesis is proven, Kapural says they will start the process of getting insurance to help cover the procedure and go from there.

“Once the trial is over, then comes the approval process,” he said. “Once fully approved if [the FDA] is happy with the results and lack of side effects, the next step is implantation through insurance companies that cover migraines. The FDA’s priority is safety but also efficiency that is comparable to standard of care or better. That is where we are now with the study.”

If you or anyone you know suffers from migraines, information on the trial, the study and where to sign up can be found at ShiraTronics.com/clinical-trial. 

Comments