Full Report: The New Implant Device That Treats Cluster Headaches

Cluster headaches are considered to be the evil relative to migraines. Both are chronic neurological disorders but cluster headaches are characterized by severe, stabbing pain behind one eye that can arise daily or semi-daily for anywhere between 15 minutes to three hours. Also referred to as the “suicide headache”, cluster headaches can be so debilitating, sufferers take their own life to escape the pain. But modern science is bringing new hope to cluster headache sufferers with the invention of a tiny implantable device that targets the source of the pain to deliver promising relief.

Discover another way cluster headaches are being treated: Chronic Migraines & The Cefaly Device

ATI Neurostimulation System

The device is called the ATI Neurostimulation System, a product of Autonomic Technologies, and includes:

  • A tiny, multi-channel implantable device (about the size of a bean)
  • A neurostimulator lead that was designed to fit a breadth of facial anatomies and extends from the implantable device to the sphenopalatine ganglion (SPG) nerve bundle
  • An external remote with varied therapy settings

How it Works

Doctors believe cluster headache pain is linked to the sphenopalatine ganglion (SPG) nerve bundle, which is located deep within the face on either side of the nose. The tiny neurostimulation device is implanted at the SPG bundle on whichever side of your face presents pain during a cluster headache. To implant, a small incision is made just above the 2nd molar in the upper gums. The procedure is considered minimally invasive and done under general anesthesia. Patients typically remain in the hospital for up to two days post surgery.

When a cluster headache arises, patients turn on their rechargeable remote and raise it to their cheek to initiate a low-energy stimulation pulse that targets the SPG nerve bundle, interceding the transfer of pain signals and relieving pain. Different therapy settings can be programmed using a laptop computer to best address pain levels and experiences. Once pain subsides, the user can lower the remote, thereby powering off the stimulator.

Why It’s Gaining Attention

What’s most impressive about this new device is that, once implanted, it requires zero routine maintenance (like replacing batteries), which means it can remain in place forever without fuss. Clinical tests have also churned up impressive results, proving that the device is capable of delivering fast and effective relief for some. In cluster headache patients involved in the clinical trial, the following results were observed:

  • 31% reduction in cluster headache occurrences per week
  • Pain relief in 67.1% of patients suffering from 15-minute cluster headaches
  • Complete pain relief in 34.1% of patients suffering from 15-minute cluster headaches
  • 64% of all patients experienced a significant improvement
  • 75% of all patients experienced clinically significant improvements

Learn about another severe migraine and headache type: 13 Indications You Have Retinal Migraines

With the proper implantation and use of this device, patients can resume all normal activities, possibly decrease medication intake and use the device for as long as is needed.

Side Effects

Side effects were temporary and consistent with other types of neurostimulation procedures, including:

  • Swelling or discomfort in the mouth or gums
  • Facial pain or pain in the cheek, gum, mandible, nose or incision site
  • Tooth sensitivity or pain
  • Hematoma (solid welling or clotting of blood)
  • Seroma (post-surgical fluid buildup)
  • Infection
  • Sensory disturbances (in 81% of patients)
  • Slight paresis of muscles around nasolabial fold
  • Dry eye or tearing 

Don’t let cluster headaches or migraines deplete your savings: Tips For Beating The Financial Burden of Chronic Migraines

Currently, the ATI Neurostimulation System is only available in Denmark and Germany, but will soon be made available to all of Europe. Planning is in progress for bringing this device to the United States and clinical studies in the US will commence at a date not yet disclosed in the near future. 

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Image Source: ThuyD


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