“Just because there’s not published literature, doesn’t mean it doesn’t work,” Holtzheimer said.
He said that the device has very few side effects and is FDA approved, but he added that some devices are “grandfathered in” because they are similar to other devices, but they still haven’t demonstrated efficacy and haven’t gone through as rigorous of testing as medication and other brain stimulation devices, so patients should still be weary even if it’s FDA approved.
Charles Avery Fisher, the president of Fisher Wallace Laboratories, said the stimulator has been around since 1991, and there are around 90 studies on the stimulator.
One study in progress is with patients who have major depressive disorder at Harvard Medical School. There are eight projects currently in progress, he said.
“A lot of them haven’t been in the last 15 minutes, they’ve been over the last … maybe the last 10 or 20 years,” Fisher said. “No matter how much research you have, someone will always find a reason to poke a hole in it.”
He said some criticism can be tied to money, since other technologies might create more of a profit.
Fisher recognizes that the Alpha-Stim technology is similar to his product.
“Ours works differently because ours is a truly transcranial device,” Fisher said. “Theirs uses ear clip adaptors, which don’t deliver the same kind of productive electrical energy that ours does. A lot is lost when you put ear clips on your ears.”
The Fisher Wallace device uses electrodes on the head, and faculty at Harvard Medical School have conducted research with the device.
However, the Alpha-Stim website states that it has 55 independent research studies that prove its effectiveness.
Both can have some side effects. The Fisher Wallace device can trigger insomnia or cause headaches in some cases, and the Alpha-Stim device can cause dizziness or nausea, skin irritation, headaches and the opposite reactions (like increased anxiety) in rare cases. Both devices are covered by some insurance companies, but it depends.
Women tend to use the Fisher Wallace device more than men – 60 to 40 percent, Fisher said.