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New Technology vs. 'Untreatable' Depression

“Nobody would try ECT [for fun],” says Lesley Galasso, who administers the Brainsway device to treat stubborn clinical depression. “Yet we all tried this [at a low frequency] when we had our training…”

We’re in a small white room in private London mental hospital, Nightingale, where the Brainsway device has been in residence for the past few weeks. “I’ve never seen anything like this before,” she tells me.  

The treatment machine was developed in Israel and is already used widely in the US and Europe on the one-third of depressed patients who are resistant to other forms of therapy. It employs TMS (Transcranial Magnetic Stimulation), which has been widely recognised by the medical community.

“The brain is an electrical machine more than anything else. And if you want to treat it in the right way you need to treat it with electricity, with electrical energy, and this is what we’re trying to do,” explains Ronen Segal, Chief Operating Officer at Brainsway.

“Even though it is very sophisticated it is very simple,” he continues “we have neurons and we have brain cells and just for simplicity they can either be an off-state or an on-state. They’re either awake or they’re asleep. And what we’re doing is we’re waking them up.”

The company believes what it is doing is different from other forms of TMS. This is ‘Deep TMS’ – it penetrates further into the recesses of the brain. “The Brainsway device stimulates superficial and, reportedly, deeper brain regions and the claim is that this leads to greater success,” clarifies Dr Michael Craig, who brought this device to the UK for the first time.

“It seems reasonable, but only time will tell whether it is that much more superior. Clearly what needs to happen is a head-to-head trial of Deep TMS and superficial TMS.” This has not happened yet.

All this is a very bold claim and potentially extremely disruptive. In the past there was only ECT which “works very well” explains Craig but “people don’t want to have it.” This is no surprise. Even beyond the memory loss it causes, ECT has had a very poor press. Who could forget Sylvia Plath’s vivid description of those two metal plates buckled to her head in 1967 autobiographical novel The Bell Jar:

“Whee-ee-ee-ee-ee, it shrilled, through an air crackling with blue light, and with each flash a great jolt drubbed me till I thought my bones would break and the sap fly out of me like a split plant.”

Things have changed a lot since then. But ECT still involves wires and an anaesthetic. In contrast, the Brainsway treatment is simply conducted in a chair, reports no side effects and patients can resume everyday activities – such as driving – after treatment. The machine does not even look especially daunting. In fact, if anything, it is faintly comical.

Galasso takes me though the whole treatment process. First there is a palaver with a blue felt hat and velcroed tape measures. This is important to find the correct spot on the head to administer treatment. With the aid of a nurse Galasso demonstrates how the helmet is tipped over different points on the head to find the right place. After this the treatment takes about 20 minutes and patents are recommended 20 sessions.

brainsway

“The most difficult thing is the noise,” Galasso says “it sounds like a woodpecker”. She leans over and taps my head firmly with a finger to demonstrate how it felt when she tried it.

The device was FDA approved for the treatment of depression about a year ago (similar devices for other conditions like PSD, OCD and bipolar are also in trial phase) and studies appear to suggest substantial results. Findings published earlier this year - based on a very small sample of 17 treatment resistant patients - show a 71% effectiveness. It also won an award this October for excellence in technology transfer.

“This does sound too good to be true,” concedes Segal who has spent 20 years in executive roles in high tech companies, including five years with Brainsway. He described his biggest surprise with the company as “the overwhelming demand from the research community to collaborate with Brainsway.”

“The next surprise was to see this accepted. It is a very conservative market and [many] physicians are old school - they know how to treat depression and you’re coming with fancy new technology. I [also] thought the market education would take a long time but once people see the results they’re coming on board very quickly.”

A future where electricity treats all conditions

For ordinary people, there may be something fairly alarming-sounding about the use of electricity to treat a variety of conditions – it is hard to shake that image of electric plates. However, as technology becomes more sophisticated and mainstream, there has been a gradual rise in so-called electroceuticals. In spring 2013, journal of science, Nature wrote a piece about a future “when electrical impulses are a mainstay of medical treatment.”

“Your clinician will administer electroceuticals that target individual nerve fibres or specific brain circuits to treat an array of conditions,” it wrote. “They could coax insulin from islet cells, regulate food intake, and control inflammation. They may treat pressing major ailments such as hypertension, diabetes, obesity, heart failure, pulmonary and vascular disease.”

One challenge is that “there are lots of different ways of trying to deliver electrical currents to the brain that are being developed,” says Dr Craig.

Over in Copenhagen, Professor Steen Dissing [PubMed listing] is in the process of producing his own depression treatment helmet. (“I call it the Captain... it’s a cap”). This was featured in the Economist back in the spring and is based around T-PEMF, a treatment neither Dr Craig nor Ronen Segal had heard of. Likewise Prof Dissing had never heard of Brainsway.

“Ours is completely different from TMS,” Dissing told us. “We have pulses that are about one million times smaller in amplitude than those of TMS. We pulse continuously for 30 minutes with 50 Hz. That’s different. Our pulses are constructed so that they mimic the pulses outside excitable tissue like nerves and striated muscles. Thus, we deliver more of the same kind to the brain.”

He describes it as “far better” than TMS with “much better scores” and cites a study he worked on a few years back which showed TMS in a less positive light. “We are the only ones with this concept [T-PEMF] and pulse - as far as I know,” he tells us.

The treatment, which he hopes will be EU approved soon, is very different from Brainsway. “It is administered by the hospital department or their own psychiatrist. They [the patient] can bring it home after instructions. There is a card that is inserted into the machine (like a VISA Card) and it records what the patient does. The psychiatrist can read the card when the patient visits. It is uploaded with 30 min treatments in a given number determined by the doctor.”

steen-dissing-via-the-economist

Image via the Economist

The challenges of packaging up the right solution

At present Brainsway and Prof Dissing’s Captain appear to be the main pre-packaged depression devices around. This is relevant because in any solution, even clinical ones, the process of how it works in practice is always integral to its take-up.

As Segal puts is: “Brainsway is not just clinical but there is a lot of technology. It is multi-disciplinary, [we] have hardware operators; the works, at Brainsway.”

Dr Craig is fairly adamant that “This particular way of doing it [employed by Brainsway] has, in my opinion, got a greater evidence base [than other systems out there]. And it is being actively taken up by a lot of research centres around the world now. It seems to be the one that people are backing as a treatment that is likely to be delivering positive results.”

The trouble, as he sees it, is “a lot of people want to come and have it” and it is not necessarily the best treatment for them if they have not already eliminated other options.

It is important to remember, Brainsway itself is a public company with a commercial offering. (Brainsway has made headlines in the past for its Stock prices surges). Treatment at the Nightingale costs around £4,000 ($6275) and in the UK is not available through medical insurance let alone on the NHS. The only other TMS accessible in the UK is via a private practice on Harley Street at around twice the price.

“Insurers will cover it [eventually],” says Dr Craig “they do in other parts of the world.” But he firmly believes “somewhere like the Nightingale has got to do what is clinically appropriate rather than taking people’s money and giving them what they’re asking for.” Ultimately he wants treatment to be available in a cost-effective way for ordinary people.

The whole area of electroceuticals “is an area that is likely to grow,” concludes Dr Craig. “I think we’re really in the infancy at the moment. We don’t quite know exactly [what works long term] as regards to delivering this treatment or what the optimum number of pulses are.”

“We hope to make Brainsway accessible to bring it to as many patients around the world as possible,” summarises Segal. “I’m not saying we’re having the magic stick here, there is still a lot of work to do to optimise, but we have so many people where this has changed their lives - it definitely works.”

 

Kathryn Cave is Editor at IDG Connect

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