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A World Beyond Medication: An Introduction into Brain Stimulation Technologies

By HERWriter
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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.

Look at the sources below for more specific information on different technologies and products.


Add a Comment10 Comments

EmpowHER Guest

I have had severe treatment resistant depression for years. After trying and failing to gain benefit from at least 8 different antidepressants, which either didn't work or caused intolerable side effects, my doctor encouraged me to consider ECT. The doctors told me the only side effect would be possible short term memory problems limited to the duration of the treatments. I had to have 16 treatments before I felt any positive effect, and that positive effect only lasted about three months. My treatments lasted about a month and caused the most crippling headaches I've ever experienced. All I could do after a treatment was take Percocet and sleep for the rest of the day. But my memory problems were much worse. Despite what they'd told me, I lost huge chunks of memory prior to the treatments, which I've never recovered, and my ability to remember things did not return to normal after treatments as promised. Instead, I became totally dependent on writing everything I needed to remember down on a little notebook I still carry with me everywhere to this day. I flunked out of college because I could not retain information long enough to pass my exams. I can't believe they say "It’s better than medication probably and it’s better than no treatment at all." If anyone is even considering getting these "treatments", I encourage you to do some research, because it absolutely ruined my life. It permanently damaged my brain. It should be illegal. And it's sickening that so-called experts are still touting it as "safe and effective".

July 15, 2016 - 11:34pm
EmpowHER Guest

I suffer from bipolar and depression. I own and have used both the Alpha Stim and the Fisher Wallace devices. Personally, and in my case ( everyone is different ), I find the Fisher Wallace device to be effective. I do a 40 minute session earlier in the day. I use the device on a lower setting. The Alpha Stim was effective for treating anxiety but did not have an effect on my depression. I highly recommend the Fisher Wallace device, but once again, everyone is different and it may not work for you. Since you will need a prescription to purchase the device, I strongly recommend you discuss this treatment modality with your physician.

May 12, 2016 - 6:30am
EmpowHER Guest

I have severe depression. I purchased the FW Stimulator. I followed the directions to the T.
Not only did my depression get worse but had insomnia so bad after using it. When I did fall asleep I had nightmares like I've never encounter in my life. I would wake up horrified. I also encountered ear problems, poping of my ears, and ringing. Please be cautious before using this device. I feel that some day someone will die from the product. This is just my opinion!

January 23, 2016 - 1:57am
EmpowHER Guest
Anonymous (reply to Anonymous)

Can you share how long it took you to recover? This device injured me very, very badly. These devices are incredibly dangerous.

August 14, 2017 - 1:32pm
EmpowHER Guest

I have tried this and it is phenomenal. I recently had a bought of anxiety and depression due to a severe sinus infection. Before the CAT scan and surgery, I was sent to a Thyroid specialist who advised the infection caused tiny cells in my thyroid to burst causing the severe insomnia (would not sleep for days), anxiety and panic attacks. The pain and anxiety started causing me some depression. I saw a psychologist because the doctors kept giving me Loratab for pain and Lorazepam for anxiety that I refused to take due to the side effects. After much research I found a Psychologist in the area who offered an alternative called Alpha-Stim. I was looking for biofeedback, but he believed this would be more beneficial and was it ever. This small device uses Cranial Electrotherapy Stimulation (CES) to dramatically reduce anxiety, pain, insomnia, panic attacks, and depression by restoring serotonin and dopamine levels in the brain. It has worked wonders for Soldiers suffering from PTSD also. The waveform passes between two electrodes that clip on to your earlobes, sending a signal to your brain that helps to reduce many behavioral symptoms. It is an amazing devise that has stopped my depression, anxiety, insomnia, pain, and panic attacks since the surgery and medication did not cure me. I basically rented this device for 5 weeks for $150.00. My husband even committed the other day, "What did you do with my Wife." Has improved our relationship and my outlook on life.

January 6, 2016 - 4:07am
EmpowHER Guest

Doctors like Holtzheimer make me sick. He only cares about people paying him $12,000 to do the TMS at his doctors office. I'd take the $600 medical device that has a money back guarantee any day of the week. Heck, those Fisher Wallace guys work with Harvard University and that probably is better than where this Holtzheimer went to school.

November 5, 2014 - 1:05pm
EmpowHER Guest

I purchased a Fisher Wallace Stimulator against the wishes of Dr. Holtzheimer. It changed my life drastically. I've cut my meds down gradually and hope to be off of my dosage altogether. There were days where I felt incapacitated due to all of the side effects of the drugs I was being prescribed. I'd feel a bit of relief, but the side effects made me need more drugs just to treat the side effects. It's a real rabbit hole with those damn drugs. I think that's why doctors don't want people using anything that's not drugs.

I decided to do it after I read that Richard Brown, a psychiatrist at Columbia University, was reporting very good results in the Wall Street Journal. Anyway, I hope people don't think it's too good to be true. I wasted months debating on whether or not to buy the device. They had a money back guarantee for two months. So what the hey? Nothing to lose!!

September 11, 2014 - 1:49pm
EmpowHER Guest
Anonymous (reply to Anonymous)

Fantastic! Congrats for thinking outside the box and trying something new and sharing your story.

October 9, 2014 - 10:57am
EmpowHER Guest

Dr. Holtzheimer's statement is depressing (!). I understand he is reporting on the lack of literature--but his comments are the first I've read that are so negative . He may be dealing with very seriously depressed people. I hope I'm not in that category--though I have had worsening depression over the last 20 years. It' going to be a cold day in hell before I do ECT b/c of the memory problems. I hope I'm not up against that wall any time soon. $12,000 for TMS is a lot. Maybe I can hang on until Medicare!

September 5, 2014 - 1:49pm
EmpowHER Guest

After years of having depression, I am indeed weary from trying different anti-depressants that don't help much, plus the bad side effects can be awful. I am also wary of any new one my doctor suggests. (Hint to writer- you might want to change the typo.) These devices seem like they would be less harmful. I highly doubt my health insurance would cover it though. If it worked well, paying out of pocket would be worth it.

June 26, 2013 - 4:24pm
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.