Neurostimulation Overload: Clinical Trials & Device Descriptions

The FDA has given Boston Scientific approval to begin a trial of occipital nerve stimulation for migraine. The specific device that will be studied is called Precision, which is the smallest rechargeable stimulator available. The study, which is being called PRISM (Precision implantable stimulator for migraine), will involve approximately 150 patients at up to 15 sites in the U.S.

The Precision works in the same way my stimulator (made by Medtronic) does. It has a battery that’s implanted in a patient’s abdomen or chests and wires, called leads, that run from the battery to the back of the head.

Until now, I assumed that "rechargeable" meant that the battery would never have to be replaced. But nothing lasts forever. Boston Scientific estimates that each battery will last about five years before it needs to be replaced.

There’s a picture on Page 4 of this PDF that compares the size of the Precision to other systems’ batteries. I’m almost positive that the largest one in the picture is comparable to the one I have.

Recruiting of participants hasn’t begun yet. Two other nerve stimulator trials are currently underway and, according to the NIH‘s database, are looking for participants. One trial is for Medtronic’s Synergy device and the other is for the Bion, made by Advanced Bionics, which is a company owned by Boston Scientific.

There’s not much information available to the public about these devices. The differences seem to be in size, whether a battery is rechargeable or not, and if the system has leads or not. A lead-less device has appeal because it is very small and there’s no worry about leads slipping, but it covers a smaller area than one with leads. The leads, while potentially more problem-prone, may provide greater relief by stimulating a larger area.

My brief summary of the different devices available:

Bion, made by Advanced Bioncs/Boston Scientific: smallest device, has no leads

Precision, also made by Advanced Bionics/Boston Scientific: small, rechargeable (although battery needs to be replaced about every five years, has leads

Synergy, made by Medtronic: comes in multiple sizes (mine’s supersize), not rechargeable (but Medtronic also makes Restore, which is essentially the same as the Synergy, but regargable)

Are you totally confused? Comment or e-mail with any questions you have and I’ll do my best to find an answer.

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