Clinical Trial to Test World’s Smallest Implant for Chronic Migraine

Clinical Trial to Test World’s Smallest Implant for Chronic Migraine

Medical device maker, StimRelieve, received approval from the FDA to begin a clinical trial to test the world’s smallest percutaneous implantable device for the treatment of migraine.

This clinical trial will assess the safety and effectiveness of occipital and supraorbital nerve stimulation using the StimRelieve Halo Migraine System for the treatment of chronic migraines. Study participants will include those who have been unable to manage chronic migraine with more conservative therapies such as NSAIDs, migraine-specific drugs, or combination drug therapy.

The goal of the study is to achieve a 30 percent reduction in headaches with no increase in medication at three months as compared to the control group that will have no active treatment during the same period.

“To date, treatments for chronic migraines have had limited and inconsistent results,” said Konstantin Slavin, MD, Professor of Neurosurgery at the University of Illinois, in a press release. “Chronic migraine headache pain is a crippling condition, disabling millions of Americans every year. If determined safe and effective, StimRelieve’s wireless neuromodulation device offers a promising option for alleviating and controlling this type of condition so that those living with this pain can better function and go on with their lives.”

The device uses wirelessly-powered neurostimulators leveraging nanotechnology. The company says it is “among the world’s smallest devices – 95 percent smaller than other implanted options – and is implantable with a standard gauge needle, thus eliminating the need for extensive surgery to the face, head and neck.”

Small size and the elimination of an implanted battery makes the surgical procedure less invasive as compared to other technology approaches, which implant the battery power source. The device gets its power from an external transmitter, which is worn on the ear – not too dissimilar to a cochlear implant.

“We are delighted to be moving forward with this study to demonstrate the potential of our product platform to address a wide variety of chronic issues with minimally-invasive neuromodulation treatments,” said Laura Tyler Perryman, StimRelieve chairman and president. “If this study demonstrates safety and effectiveness, StimRelieve can help millions of people in the U.S. who are suffering from chronic migraines, without the need for extensive surgery or bulky implants in their chest.”

The International Headache Society defines chronic migraine as more than fifteen headache days per month over a three month period of which more than eight are cluster headaches, in the absence of medication over use. Episodic migraine is the other migraine sub-type, which is defined as less than 15 headache days per month.

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Authored by: Staff

There are 9 comments for this article
  1. Judith Joseph at 3:05 pm

    My cluster headache episodes stopped for 12 years! Out of nowhere they ce ame back and have been crippling siince the beginning of Spring; I recall they always spoiled my summer, my work and my family life. Sumatriptan and Oxygen can be helpful for acute episodes although sumatriptan has difficult side effects including stomach distress.

    I just recovered from knee and shoulder replacements and was doing great so this reappearance of the cluster episodes is awful. I would gladly be compliant wanting to help myself and others.

  2. Rachel at 9:13 pm

    I would suggest contacting the company who made this if you’re in being included in the trial. Leaving a message here probably doesn’t do any good.

  3. Shelley DeShazo at 7:27 pm

    I have been having migraines for years …I. have them at least 4 times a weeks some lklasting for 3 or longer days at a time along with spots I just can’t stand the pain

  4. Lynnette at 1:03 pm

    How can someone b e included in the trials. No meds have worked for my son. They are migraines all the time. He is disabled by them and has had them for 7 years. Lynnette

  5. Susan Follett at 4:13 am

    I have had seve r email daily migraines for 43 years. I have tried every medication there is and nothing helps. I have been everywhere trying to get help
    I am begging you please to include me in this study
    Thank you.

  6. Amanda Stark at 7:02 pm

    I have had chronic migraine for over 8 years. Its intractable. The pain is 24 hours a day every day without ever having a pain free second. I have never had a break in the pain as it is constant day and night therefore I do not have any pain free time therefore I cannot use preventatives. I have tried everything and have not found any pain relief. Until something new comes along to try i am stuck in this nightmare ‘non life’. If there is a trial that might help bring me some pain relief I would be so grateful.

  7. rosanna zdunich at 3:06 pm

    I am crippled by chronic migraine,and would very much like to qualify for this trial.

  8. Veronica Clark at 3:04 pm

    How does a person get qualified for this trial? I’ve been disabled due to migraines since 2002. Can’t work, can’t do my housework, can’t be ‘normal’ without getting a migraine for attempting anything. I also have fibromyalgia, and sjogrens – but the migraines are what are kicking me down. The other pain is just that, pain. The migraines put me down, sometimes for a week at a time. I really want to try this, please!