EU Approves New Fibromyalgia and Migraine Device

A new device that uses transcranial Direct Current Stimulation (tDCS) has received approval in Europe for the treatment of fibromyalgia and migraine headache.

The product, called PainX uses an array of electrodes positioned on the scalp that deliver low-intensity direct current to a region of the cerebral cortex to either control perception of pain or modulate reaction to painful experiences.

Treatment is typically administered daily for 3 weeks with additional continuation sessions administered weekly for a total of around 20 sessions. According to its manufacturer, Soterix Medical, in clinical studies most people experienced rapid benefit. Some studies showed sustained benefit ranging from 3 to 12 weeks post-stimulation.

“tDCS is a highly-promising therapy for adults living with chronic pain without the systemic side effects commonly associated with oral pain medications,” the company noted in a press release.

“Many chronic pain disorders are associated with neuropathic pain, meaning pain that originates through maladaptive plasticity in the brain,” said Dr. Abhishek Datta, CTO of Soterix Medical.  “The PainX tDCS therapy enhances adaptive plasticity encouraging correction of brain activity. Critical to the validation of a safe and effective treatment for pain, was over 5 years of design and testing of the PainX stimulator and headgear.”

“We are glad Soterix Medical can bring light into the lives of patients suffering from chronic pain disorders,” said Shani San Solo, VP Europe Business for Soterix Medical. “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.”

The company said “the treatment is available immediately in the EU.”  It is not approved in the United States.

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