Developed by global medtech company BrainsWay, Deep Transcranial Magnetic Stimulation (Deep TMS™) targets treatment-resistant conditions such as depression, anxious depression, obsessive-compulsive disorder (OCD), and smoking addiction.
“A significant unmet need exists in the treatment of mental health and addiction conditions.
“Current treatment options such as pharmacotherapy, psychotherapy, and electroconvulsive therapy might not work for a substantial population of patients,” says BrainsWay CEO and President Christopher von Jako, Ph.D.
BrainsWay’s patented breakthrough treatment based on Deep TMS begins a new era in brain stimulation and research by offering another effective treatment option.
BrainsWay Deep TMS is a clinically proven, noninvasive in-office brain stimulation procedure that uses magnetic fields to activate neural networks in the brain to improve symptoms of mental health and addiction conditions.
Deep TMS has been validated in 60+ sham-controlled trials involving over 3,000 patients.
Clinical and real-word studies have shown that Deep TMS is an effective treatment, particularly for patients who have failed to achieve sufficient benefit from medications.
Research on Deep TMS has led to 300+ publications.
A key differentiator for Deep TMS is that it delivers deeper and broader stimulation than traditional TMS systems, resulting in greater activation of neurons, less likelihood of targeting errors, and powerful efficacy.
Major depressive disorder accounts for much of BrainsWay’s customer base, with clinicians treating patients throughout the US and the world.
In 2019, almost a fifth of Americans had symptoms of depression.
But current treatment options like pharmacotherapy and psychotherapy do not work for a substantial population of patients, and the yearly burden for United States economy is over $320 billion.
The widely cited Star*D trial demonstrates diminishing clinical benefit and increasing incidence of side effects with successive pharmacological treatments for depression.
While psychotherapy is a valuable treatment tool, it requires lengthy treatment and is best supplemented with medication or neuromodulation treatment for more challenging patients.
Clinical studies have shown Deep TMS to be highly effective at treating symptoms in these patients, with no adverse or long-term side-effects.
It also is covered by nearly all major medical insurance companies in the US.
Some patients will only need one course of TMS treatments in their lifetime.
But as depression is episodic by nature, other patients will return to the clinic to treat subsequent episodes.
Dr. von Jako says:
“We’re treating the hardest of hard patients.
“These people have already not responded to medication, or they’ve had such bad side effects that they’re looking for an alternative.
“Sometimes patients stay on their medication because they feel that their medicine works better in conjunction with TMS. So, it can vary depending on the patient. Everyone’s brain is a little bit different.”
BrainsWay received its second FDA clearance to treat OCD, which is a chronic and debilitating condition with a lifetime prevalence in the US of 2.3 per cent.
Characterised by uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions) that the sufferer feels compelled to repeat over and over, OCD is considered by the World Health Organization (WHO) to be one of the top 10 debilitating medical conditions associated with a decreased quality of life and loss of income.
Due to the complexity and heterogeneity of the condition, coupled with the high percentage of patients that are drug-resistant, many patients suffering from OCD do not respond well to first line treatment options.
The economic burden on the U.S. healthcare system for OCD treatments is estimated to be over $10.6 billion per year.
There are currently only five FDA-approved medicines for OCD available in the US.
A multi-centre double-blind clinical trial found Deep TMS to be highly effective at treating patients with treatment-resistant OCD, with more than a third of patients achieving a response.
In recognition of the clinical data, insurance companies are expanding coverage for OCD.
Currently, Cigna, Centene, Highmark, Health Care Services Corporation, Blue Cross Blue Shield, Tricare, and Palmetto GBA Medicare all cover Deep TMS to treat OCD, resulting in over 86 million adults covered by their insurance plans for BrainsWay’s pioneering Deep TMS OCD treatment.
Recent studies have shown that BrainsWay’s H7 Coil for OCD has depression benefits, too.
Dr. von Jako says:
“Our collaborators tried the H7 Coil on depression patients who had been unsuccessfully treated with our H1 Coil or traditional TMS. And these patients got better.
“We ran a multi-centre trial of roughly 150 patients and showed that there were some benefits to using this different treating coil for depression patients.
“We know that about half of OCD patients have depression as well. And as we’ve treated these OCD patients, their depression has been getting better. But we didn’t know pure depression patients could get better.
In August, the FDA granted BrainsWay a clearance to treat depression patients with the H7 Coil as well as the previously cleared H1 Coil.
“We believe that this clearance may advance our goal of enabling clinicians to provide more personalised medicine for their patients depending upon what works best for them,” says Dr. von Jako.
He is also excited about BrainsWay’s ongoing addiction research.
Its first addiction product has been cleared by the FDA for treatment-resistant smoking addiction.
Many patients turn to Deep TMS after unsuccessfully trying nicotine replacement therapy or prescription medication, such as Chantix/Champix.
Nearly one in three patients that completed 18 sessions of Deep TMS achieved four or more weeks of abstinence from smoking in a large scale, double-blind multicentre randomised controlled trial.
Two of three patients who quit smoking by the end of the treatment remained abstinent for at least an additional three months.
Many additional patients experienced significant reduction in the average number of cigarettes smoked per week.
Dr. von Jako says:
“These other methods are not helping many people who suffer with smoking addiction.
“Some people can stop smoking for a number of reasons. A husband might quit to support his wife when she gets pregnant. Or he might have a heart attack and vow never to smoke again. But, for other people, it’s a hard habit to kick.
“We’ve seen in our clinical trials that we can help these patients break the cycle. I believe that if you can stop that cycle for a certain period of time, you can get rid of that habit in general.”
BrainsWay is now looking at how Deep TMS could take on other addictions. Pilot studies have shown promise with alcohol, and they are now looking at other areas.
Dr. von Jako says:
“There are some really unique and interesting potential applications for our platform technology.”