FDA Clears BrainsWay Deep TMS Device For Anxious Depression

Every year, almost 7% of U.S. adults are affected by depression. Depression is a mental health condition that causes feelings of sadness, hopelessness, and numbness. It can also affect your thoughts and behavior. 

Most of the time, depression can be treated with therapy and medications. But in some cases, they’re not enough. When therapy and medication haven’t worked (sometimes referred to as treatment-resistant depression), other treatments can help. One of these treatments is a medical procedure called transcranial magnetic stimulation (TMS). 

TMS was first approved by the FDA in 2008 for treatment-resistant depression. Since then, it’s been FDA-cleared for other conditions — including anxious depression in August 2021. 

Read on for more information about anxious depression, Deep TMS, and what to expect from treatment. 

What is anxious depression?

Anxiety and depression are two separate conditions. But the truth is, many people with depression also have some anxiety symptoms. Healthcare professionals sometimes call this “depression with anxious distress” or “anxious depression.”

People with anxious depression have depression and at least two of the following five anxiety symptoms:

1. Feeling jumpy or on edge

2. Feeling like you can’t sit still or calm down 

3. Problems focusing because of your anxiety

4. Worrying about terrible things that might happen

5. Worrying about losing control of yourself

What is transcranial magnetic stimulation (TMS)? 

TMS is a medical procedure used to treat depression. It’s also being studied for other mental health conditions. It’s typically used when other treatments (like therapy and medications) haven’t worked.

TMS is a non-invasive procedure. This means it doesn’t break the skin, and there are no tools or devices that enter your body. It works by sending painless magnetic pulses into your brain. This stimulates your nerve cells and can help depression and anxiety symptoms go away.

A typical course of TMS treatment is usually 20 to 30 sessions, spread out over 4 to 6 weeks. 

How is Deep TMS different from TMS?

Deep TMS is a trademarked TMS technology made by a company called BrainsWay. The Brainsway Deep TMS device generates magnetic fields that can penetrate deeper and more widely in the brain than other types of TMS devices. 

Deep TMS is FDA-cleared for:

• Major depressive disorder

• Obsessive-compulsive disorder (OCD)

• Smoking cessation

• Anxious depression

Deep TMS is also different from repetitive TMS (rTMS) — which is discussed more here.  

What does Deep TMS feel like?

During a Deep TMS session, you sit comfortably in a chair. A helmet-shaped device is fitted to your head by a healthcare provider. 

Once the device is turned on, you may notice a tapping noise or sensation. During the 20-minute treatment you can read or do another quiet activity. 

Deep TMS doesn’t require sedation (anesthesia) and isn’t painful. When the procedure is over, you can resume your normal activities — including driving yourself home. 

How does Deep TMS help anxious depression?

We don’t know for sure why TMS helps with anxious depression. But, there’s a potential theory. 

People with anxiety and depression may have different patterns of brain activity in an area called the dorsolateral prefrontal cortex (DLPFC). This area is stimulated during Deep TMS. The magnetic stimulation seems to help the DLPFC function better, which may be why it can help treat depression and anxiety.  

How soon can you start seeing results from Deep TMS?

The Deep TMS treatment course for anxious depression is 30 to 36 sessions, each lasting about 20 minutes. These sessions are spread out over 2 to 3 months, and each week contains about 5 treatments. 

According to BrainsWay research, Deep TMS starts to work for anxious depression in 1 to 2 weeks, with the best results first seen about a month into treatment. 

What are the side effects of Deep TMS?

Deep TMS doesn’t have a lot of side effects. Some people have slight pain or discomfort at the treatment site. It’s also possible to have mild headaches at the beginning of treatment — though these seem to get better as time goes on. Some people may also experience jaw pain. 

In rare cases, Deep TMS can cause seizures. But according to the manufacturer, this is very rare. In a study of Deep TMS treatments from 2010 to 2020, only about 2 people out of every 10,000 had a seizure. 

How long do Deep TMS results last?

It’s hard to predict how long Deep TMS results will last. This is because depression can naturally come and go for many people. So even if TMS works, it’s possible that you could still have another episode of depression in the future. 

More research is needed in this area. So far, there have only been a few small studies on the long-term effects of Deep TMS. One small study of 17 people found that relapse rates (a return of depression) for Deep TMS were about the same as for therapy and medications.

There’s also evidence that regular maintenance therapy (ongoing Deep TMS treatments) could lower your chance of relapse. However, it’s not clear how frequently this should be done. 

Who should not do Deep TMS?

Certain groups of people should not have Deep TMS. This includes people who:

• Haven’t yet tried antidepressant medications

• Have metal plates or devices planted in or around their head (with the exception of some dental fillings and implants)

• Have an implanted electronic device, like a pacemaker

• Have a seizure condition or a high risk for seizures

• Are having suicidal thoughts

• Are experiencing psychosis

• Are pregnant or nursing

• Are using substances like drugs or alcohol

Is there an age limit for Deep TMS?

Deep TMS is only FDA-cleared for people ages 18 and over. People outside of this age range may be able to have Deep TMS with a healthcare provider’s OK as an “off-label” treatment.

In a clinical trial that investigated Deep TMS for people with depression without anxiety, adults over 68 were not included. More caution should be taken for older adults to make sure Deep TMS is both safe and effective for them.

Can you receive Deep TMS at home?

No. Deep TMS can only be done in a clinical setting by a licensed healthcare professional. If getting to your local Deep TMS clinic site is not feasible, it’s best to discuss your options with your healthcare provider.