At-home brain stimulation relieves symptoms of depression, study finds

(CNN) — A headset worn at home that zaps the brain with the energy of a 9-volt battery could help relieve symptoms of depression, a new study shows.

The study, which was published last week in the journal Nature Medicine, found that 87 adults with at least moderate depression who used the headset for 10 weeks had a greater improvement in their depression symptoms than 87 others who wore a similar-looking inactive headset over the same time period.

What’s more, twice as many people in the group that got the active treatment reported remission of their depressive symptoms compared with people in the placebo group: 45% vs. 22%.

“Remission means they don’t have an active mood episode anymore,” said Dr. Rodrigo Machado-Vieira, a psychiatrist who directs the Experimental Therapeutics and Molecular Pathophysiology Program at UTHealth Houston, which was one of the sites that recruited patients for the study.

In other words, if patients who had achieved remission using the device took a questionnaire asking them about their symptoms, they might report some issues — perhaps sleep problems or anxiety — but they wouldn’t score high enough to qualify as clinically depressed, he explained.

Machado-Vieira said the company that makes the headset funded the study, but the money went into a general research fund at his university. He said he personally had no financial stake in the product.

Rebalancing brain activity in depression

The device is available in the UK, Norway, Hong Kong and countries in the EU. It’s made by a Swedish company called Flow Neuroscience, which says it is in late stages of seeking approval from the US Food and Drug Administration to market the device for depression in the United States.

Similar devices are on the market in the US, but most don’t claim to treat any kind of symptom or condition. Instead, they promise to improve alertness and focus, and they may not target any particular regions of the brain.

The Flow Neuroscience headset uses an app with a video tutorial, as well as a telemedicine visit, to make sure people are able to correctly position the two electrodes to stimulate two specific brain regions. The first is the dorsolateral prefrontal cortex, an area of the brain that’s involved in executive function and cognition. The second is called the ventromedial prefrontal cortex, which is involved in emotional regulation. Studies show that people with depression tend to have less brain activity than normal in the dorsolateral prefrontal cortex and more brain activity than normal in the ventromedial prefrontal cortex.

The device is designed to speed up brain activity in the region that’s moving too slowly and slow it down where it’s overactive, said Daniel Mansson, a clinical psychologist who co-founded Flow Neuroscience.

“So you’re trying to rebalance the activity,” he said.

The device doesn’t cause nerve cells in the brain to fire, but it makes it easier for them to be stimulated to work properly using a method called transcranial direct current stimulation.

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

A ‘spicy’ sensation with brain benefits

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

Since she was a teenager, De Hoyos has grappled with mental health issues, so when she got an email from her psychiatry clinic asking if she wanted to help test the Flow headset, she didn’t hesitate.

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

For the study, she would put on the headset and log onto a computer meeting where a study observer would keep an eye on her for 30 minutes while she did the treatment.

She says the brain stimulation starts with a slight buzzing and maybe a little tingling and burning.

“If you’ve ever had your hair bleached, it feels like that, weirdly,” De Hoyos said. “It’s a little bit of a spicy sensation.”

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

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

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

After she used the headset, though, the doom piles started to disappear.

“There was some moment that finally I was like, ‘Oh, my gosh. I’m actually able to stay on top of this stuff and attack it without much outside help,’” she added.

She had to give the headset back when the study ended, but she said she would use it again if it becomes available in the US.

Helping people use brain stimulation at home

Fu says that when her team started looking at transcranial direct current stimulation for depression, they first reviewed the medical literature.

They found many studies showing that the technology could be effective, but all provided the therapy in a clinical setting. It has to be done routinely to work, and that seemed too cumbersome for patients.

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

She says the study proves that people can use the technology safely and effectively on their own, without having to go to a doctor’s office.

Fu says she thinks it works well enough that it could become a first-line treatment for depression. It could also work as an add-on for people who feel like they’re not getting enough help from medication.

It’s not 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 who had been in the placebo arm could use the active headset. That phase of the study lasted another 10 weeks, so people were in the active part of the study for about five months, in total.

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

“We’re just submitting that for publication,” she said. “People continue to stay well, in general, but it needs to be looked at.”

Flow Neuroscience’s Mansson said the device hasn’t been studied for specific types of depression, such as seasonal affective disorder or postpartum depression, but since it is approved for major depressive disorder in Europe, they are able to treat those subtypes, too.

It seems to be pretty safe – there were no serious adverse events in the clinical trials – but certain people need to be careful about using this kind of device and should talk to their doctors, Mansson said. They include:

• People who are pregnant
• Those under age 18
• Anyone who is having suicidal thoughts
• People who have had a stroke
• Those who have a history of epilepsy or seizures
• people who have had brain surgery or have metal clips or a metal plate in their head
• Those who have a skin condition, like psoriasis, that could affect the skin on their forehead
• Anyone with bipolar disorder

De Hoyos said that overall, she noticed some slight positive effects from using the device and wished she could have used it longer.

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

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