Have you tried various medications and therapy for your depression, anxiety, insomnia or other mental health issues with no success? Are medication side effects too severe to handle? Within the last several years, multiple brain stimulation technologies have popped up to assist treatment-resistant mental disorders and other health issues.
One alternative treatment option for people with depression, anxiety, insomnia, migraines and chronic pain is the Fisher Wallace Cranial Stimulator. The device requires a prescription in the United States and costs $695, with a $200 per month payment plan. There is a 60-day full refund return policy if the device doesn’t decrease symptoms.
According to the website, “the device generates micro-currents of electricity using patented radio frequencies that have been shown in peer-reviewed research to stimulate the brain’s production of serotonin and dopamine.”
A competing technology is Alpha-Stim. There are two Alpha-Stim devices, one that costs $995 and the other $595. These devices also require a prescription in the United States and treat pain, anxiety, depression, insomnia and stress-related disorders, according to the company’s website. There is a five-year warranty.
Both are portable devices that can be used at home.
However, Paul Holtzheimer, an assistant professor in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine, is not so confident about the stimulator’s effectiveness.
He specializes in treatment-resistant depression and brain stimulation therapy, and works mainly with transcranial magnetic stimulation, but he is familiar with the Fisher Wallace Cranial Stimulator and its competitor, Alpha-Stim.
“I have not prescribed it largely because the published data essentially is absent for supporting a strong antidepressant effect,” Holtzheimer said, adding that he feels the same about the Alpha-Stim device.
He said he works more with people who have failed one or two medications, and the stimulator probably has only mild antidepressant effects for those types of patients, but he doesn’t completely doubt the device’s usefulness.
“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.
“Women tend to be open to therapies like this a little bit more,” he said.
Fisher has a personal interest in this technology. He suffered from seasonal affective disorder and medications weren’t successful for him and others he knew. He looked into the technology and found how useful it was.
However, Holtzheimer has more confidence in the effectiveness of other devices, at least for treatment of depression.
“The one I have the most direct experience with and the one that has probably the most published literature on is transcranial magnetic stimulation,” he said.
He added that one company that produces the technology is Neuronetics, with the Neurostar device. The company was incorporated in 2003 and “began by licensing a revolutionary patented coil design from Emory University,” according to the company’s website.
“TMS uses an electromagnetic field to generate electric current in the cortex. It’s non-invasive but it actually activates cortical neurons,” Holtzheimer said.
Research backs up the effectiveness of TMS, he said.
“Over nearly almost 20 years of research, TMS has consistently shown that it has antidepressant effects, and that includes a number of placebo-controlled studies as well,” Holtzheimer said.
It does have some downfalls, including the possibility of “scalp pain and discomfort at the site of administration,” according to the Neuronetics website.
“The only potential downside of TMS is that inpatients that have failed more than one or two medications, it probably has a lower likelihood of success. But in patients who have only failed one or who just don’t tolerate medications, it’s probably more effective,” Holtzheimer said.
TMS is different from the cranial electrotherapy stimulation devices, like the Fisher Wallace Cranial Stimulator, he said.
“The Alpha-Stim and the Fisher Wallace system deliver a very low dose of electricity directly through the brain, but it is not strong enough to activate brain cells directly,” Holtzheimer said. “In TMS, the current that’s induced in the brain is strong enough to actually … activate the neurons … The way that TMS is activating the brain is very different and probably much stronger than the other two devices.”
TMS is not covered by Medicare or most insurance companies, he said.
There are many other brain stimulation options as well, including the well-known electroconvulsive therapy. This therapy uses a machine to deliver energy to electrodes that are attached to the head in order to stimulate the brain.
““It’s actually a reasonably safe treatment the way we do it today, not necessarily the way it was done in the 1950s or earlier,” Holtzheimer said. “It remains the most effective treatment for a depressive episode. If you want to get somebody who’s depressed out of their depression, the most effective way to do it would be to give them ECT. It’s better than medication probably and it’s better than no treatment at all.”
Although it’s effective and safe, there are still lingering fears over past abuse.
“The reason we don’t use it probably more is that a lot of patients are afraid of it because they’ve seen “One Flew Over the Cuckoo’s Nest” or heard horror stories about other patients who had ECT,” he said “The other reason is that you have to come in two to three times a week for an ECT treatment. You’re under general anesthesia, so there’s a recovery period so it’s almost impossible to work while you’re getting the treatment.”
The treatment happens over three to four weeks. Also, there can be cognitive side effects, like short-term memory problems and confusion, that usually don’t last long for most patients, he said. However, because of the above, this treatment is usually saved for patients who have resistance to other treatments.
In patients with more severe depression, where they are suicidal and stop eating, ECT can be a first option.
“We will sometimes use ECT sooner than [for] … another patient because we really want to get them out of that depressive episode for their own safety as quickly as possible,” Holtzheimer said.
ECT is covered by Medicare and most insurance companies, and is available to patients who need it, he said.
Although deep brain stimulation, another brain stimulation technology, is getting more popular, it’s still not approved as a treatment option for depression.
“If [deep brain stimulation] works … it’ll be appropriate for those patients who have failed multiple medication trials and possibly even ECT,” he said. “These are patients who are most treatment resistant.”
In DBS, holes are drilled into the skull, electrodes are placed in a specific brain region, and a battery pack is implanted in the chest so that it can deliver constant stimulation to the electrodes that are attached to it, Holtzheimer said.
It is more invasive than the other therapies because of the surgery involved. Although the ongoing brain stimulation appears to be safe, the surgery to implant the devices can have complications, like infection, bleeding, hemorrhages and strokes, he said.
“Deep brain stimulation is only investigational, so the only way to get DBS currently is either in a clinical trial or to convince a neurosurgeon to implant the device under compassionate use,” Holtzheimer said.
Another brain stimulation technology is vagus nerve stimulation, which is approved for use by the FDA.
“You attach a wire around the nerve in the neck that actually projects into the brain,” Holtzheimer said. This therapy is not covered by Medicare and not by most insurance companies, he added.
Transcranial direct current stimulation is another investigational brain stimulation technology that Holtzheimer said is similar to the Fisher Wallace Cranial Stimulator device because it delivers stimulation to two electrodes on the scalp. However, it uses a direct current, while the Fisher Wallace device uses an alternating current.
The above technologies can be expensive and oftentimes inaccessible to the general population because of the costs, but in some cases the therapies save money long-term, considering the comparative cost of taking antidepressants for the rest of one’s life with sometimes negative side effects.
Some people might be concerned about their personality changing because of using these brain stimulation technologies.
“There has been no evidence that they do change your personality [or] make you into a different person,” Holtzheimer said. “Patients that get well … almost always report that they’re back to themselves. They were not themselves while they were depressed. They’re back to themselves when they’re not depressed.”
ECT is still more of a concern to some, but when used appropriately there is “no evidence that it has any personality effects, dulling effects,” he said.
Also, many patients with severe depression are more concerned about relieving depression instead of having other possible side effects, he said.
“The idea of these brain stimulation therapies … is extremely exciting for psychiatry, this idea of non-pharmacologic approaches,” Holtzheimer said.
However, he does have a word of caution.
“The nature of the field and companies and marketing is such that they’re being promoted and they’re kind of becoming “mainstream” perhaps before we have the data to truly know how well they work and how safe they are,” Holtzheimer said.
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