EU Approves New Fibromyalgia and Migraine Device

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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Authored by: Staff

There are 7 comments for this article
  1. Kristine (Krissy) at 4:21 pm

    THANKS, DONNA
    I was aware of that, but thank you. Just wanted to if it was pre-paid. I believe I though I was writing to the general “contact me” area. LOL

  2. Celeste Cooper at 12:11 pm

    Doesn’t look like the FDA has approved for Americans. A crying shame that we don’t have the same choices.

  3. Doctor Fugedy at 9:09 am

    tDCS has been used to treat fibromyalgia, migraine and psychiatric conditions at the Brain Stimulation Clinic in Atlanta since 2007. Training and supervision for tDCS self-dministration is available for chronic, treatment-resistant conditions.

  4. Dave at 10:11 am

    This is a victory for those who believe in the neurocentric model and gate theory of pain. But I fear, that of it does reduce pain the person with fibromyalgia or migraine will be lead to believe that they are well or healed.
    The problem with the neurocentric or gate theory – is it has limited explanatory power and doesn’t even bother to explain phenomena from competing theories like the energy crises model. Problems with migraine and fibromyalgia have been explained by problems with mitochondira and metabolism. The neurocentric model and gate theory, of course dismiss the role of metabolism and mitochondria, as irrelevant.
    While it is conceiveable that pain may be greatly reduced by changing nerve sensation- this may not be optimal- as the underlying pathology may remain unaddressed. And the underlying condition may worsen- though the person is feeling no pain.

  5. Jeremy Goodwin, MS, MD at 12:17 pm

    Well, it appears that we are inching toward the magical appearing healing machine used by ‘Bones’ on Star Trek. It is via various forms of Neuromodulation treatments. We have all sorts of variations on the original TENS units and spinal cord stimulators. Soon we will develope treating clinician’s called Neuromodulatory central and peripheral nervous system sensory processing programmers who may not require a permanently or surgically implanted device, although I think that the interdisciplinary, integrative and multi-modal approach will change but not disappear.

    Twenty nine years ago I directly experienced the earliest prototypes of trans-cranial magnetic fields applied to the cortex in order to experience its disrupting affects on speech output despite language comprehension and response being normal. It was the closest that I have come to understanding how a patient feels when the words are voiced inside one’s head in response to a question but scrambled as they are voiced. That is now being increasingly well defined in terms of pain and epilepsy treatment.

  6. Donna at 7:08 am

    Krissy,
    That is an ad for a prepaid credit card and is not an actual part of the article. Hope this helps.

  7. Kristine (Krissy) at 5:44 am

    It says no credit check. Is this a pre-paid card?