Fibromyalgia and migraine headaches are just two pain conditions that debilitate millions of people. A new pain-relieving device has just been approved for both of the conditions, but there’s a catch.

The PainX tDCS Therapy device received the CE Mark approval after 14 studies over the course of eight years resulted in positive results for multiple painful conditions, including spinal cord injury. However, the device is only available on the European market for now.

“Many chronic pain disorders are associated with neuropathic pain, meaning pain that originates through maladaptive plasticity in the brain,” Abhishek Datta, PhD, CTO of Soterix Medical, explained in a news release.

The MD Magazine Fibromyalgia condition center

The battery-powered device delivers a low-intensity current to the cerebral cortex. The PainX headgear works by either controlling perception of pain or altering the reacting to pain. It does this by enhancing “adaptive plasticity encouraging correction of brain activity.” The developers reassure patients that the therapy underwent five years of design and testing for not just efficacy, but safety as well.

“The CE approval allows our unique tDCS technology to provide an effective, safe and well-tolerated solution for the severe conditions like fibromyalgia, migraine, and other forms of chronic pain,” said Shani San Solo, VP Europe Business for Soterix Medical.

Some of the studies showed the patients continued to reap the benefits of the PainX for three to 12 weeks following treatment. Itching and tingling were the most side effects and in rare cases headache occurred.

All in favor of moving forward for the American market?

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