Home brain stimulation headset that produces a ‘spicy’ buzz may ease symptoms of depression

A headset worn at home that charges the brain with a 9-volt battery may help relieve symptoms of depression, a new study suggests.

The study that was published last week in the journal Nature Medicine found that 87 adults with moderate depression who used a headset for 10 weeks had greater improvement in depressive symptoms than 87 other people who wore a similar inactive headset over the same period of time.

Moreover, twice as many people in the active treatment group reported remission of depressive symptoms compared to people in the placebo group: 45% versus 22%.

“Remission means they no longer have active mood episodes,” said Dr. Rodrigo Machado-Vieira, a psychiatrist who directs the experimental therapeutics and molecular pathophysiology program at UTHealth Houston, which was one of the centers that recruited patients for the study. .

In other words, if patients who achieved remission with the device filled out a questionnaire that asked them about their symptoms, they might report some problems—perhaps sleep problems or anxiety—but they would not score high enough to qualify as clinical depression, he explained. .

Machado-Vieira said the headset company funded the research, but the money went into his university’s general research fund. He said he has no personal financial interest in the product.

Restoring the balance of brain activity in depression

The device is available in the UK, Norway, Hong Kong and EU countries. It was created by Swedish company Flow Neuroscience, which says it is in the late stages of seeking approval from the US Food and Drug Administration to sell the device to treat depression in the United States.

Similar devices are available on the US market, but most do not claim to treat any symptoms or conditions. Instead, they promise to improve alertness and concentration and may not target any specific areas of the brain.

The Flow Neuroscience headset uses an app with video tutorials, as well as a telemedicine visit, to ensure people can correctly position two electrodes to stimulate two specific areas of the brain. The first is the dorsolateral prefrontal cortex, a region of the brain that is involved in executive functions and cognition. The second is called the ventromedial prefrontal cortex, which is involved in emotional regulation. Research show that people with depression tend to have less brain activity than normal in the dorsolateral prefrontal cortex and higher brain activity than normal in the ventromedial prefrontal cortex.

The device is designed to speed up brain activity in areas that are moving too slowly, and slow them down where they are too active, says Daniel Mansson, a clinical psychologist who co-founded Flow Neuroscience.

“So you try to balance activities,” he said.

The device does not excite the brain’s nerve cells, but makes it easier for them to be stimulated to function properly using a technique called transcranial direct current stimulation.

“It uses a weak current, a small electrical current, that modulates the action potential of the neuron, so it’s easier for the neuron to fire or discharge,” said Dr. Cynthia Fu, a professor at King’s Center for Mood Disorders. College London, which led the study. Fu said she also has no financial interest in the device.

“Spicy” sensation with benefits for the brain

Leana De Hoyos, a 34-year-old mother of two living in Houston, was one of the study participants.

De Hoyos had struggled with mental health issues since she was a teenager, so when she received an email from a mental health clinic asking if she would like to help test the Flow headset, she didn’t hesitate.

“One of the worst symptoms I have is called executive dysfunction, and that’s where in my head I want to do something, but physically I can’t bring myself to do it,” De Hoyos said. “For some reason I’m just overwhelmed or I just can’t.”

For the study, she put on a headset and logged into a computer conference room, where a study observer observed her for 30 minutes while she administered the treatment.

She says brain stimulation begins with a slight buzzing sound and perhaps a slight tingling and burning sensation.

“If you’ve ever bleached your hair, you’ll feel it, oddly enough,” De Hoyos said. “It’s a bit of a spicy feeling.”

It took a few weeks, she said, but she noticed a change. “The more I did it, the more I noticed that I was a little more motivated to actually do something.”

De Hoyos said one of her biggest challenges is keeping her house clean.

“I have things that I call the doom pile, which is like a bunch of random stuff that needs to be put away and you don’t know where it should go,” she said.

However, after she used the headset, the piles of doom began to disappear.

“There was a point where I finally thought, ‘Oh my gosh. I can actually stay on top of it all and attack it without much outside help,” she added.

When the study ended, she had to return the headset, but said she would use it again if it became available in the US.

Helping people use brain stimulation at home

Fu says that when her team began studying transcranial direct current stimulation for depression, they first looked at the medical literature.

They found many studies showing the technology could be effective, but all involved the therapy in a clinical setting. It had to be done regularly to work, and patients found it too burdensome.

“We thought, ‘OK, let’s see if we can provide this at home,'” Fu said. They created a new protocol and tested it.

She said the study proves that people can safely and effectively use the technology on their own, without needing to see a doctor.

Fu says she thinks it works well enough to become a first-line treatment for depression. It may also work as a supplement for people who feel that medications are not helping them.

It is not yet clear how long the effects of the device last, she said.

After 10 weeks in the placebo or treatment group, the study was unblinded, so those in the placebo group could use an active headset. This phase of the study lasted an additional 10 weeks, so people were in the active part of the study for a total of about five months.

After completing the study, they checked in with participants at three and six months to see how they were doing, Fu said.

“We’re just submitting it for publication,” she said. “Overall, people are still doing well, but it’s something that needs to be looked at.”

Flow Neuroscience’s Mansson said the device has not been studied for treating specific types of depression, such as seasonal affective disorder or postpartum depression, but because it is approved for major depressive disorder in Europe, it has the potential to treat those subtypes as well.

It appears to be fairly safe—there were no serious side effects found in clinical trials—but some people should be careful when using this type of device and check with their doctors, Mansson said. They include:

• Pregnant people

• Those under 18 years of age

• Anyone who has suicidal thoughts

• People who have had a stroke

• Those with a history of epilepsy or seizures.

• people who have had brain surgery or have metal clamps or a metal plate in their head

• Those who have a skin condition such as psoriasis that may affect the skin of the forehead.

• Anyone who suffers from bipolar disorder

De Hoyos said overall she noticed some small positive effects from using the device and would like to use it longer.

“I felt like I was getting close to a breakthrough right before we finished the study. I felt like it wasn’t enough for me,” she said. “I really wanted to do it more and see if I did it more if it would help even more.”

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