Promising Smoking Cessation Option: Brain Stimulator Now Approved

J.Adderton, BSN, MSN

For smokers, the risk of developing COPD and other related diseases is greatly reduced if you’re able to quit the habit for good. There are smokers who are able to walk away from tobacco every day. But, it’s rarely easy and often takes several attempts.

Most Want to Stop

Smoking is a serious addiction that harms just about every organ in the body. When surveyed, most adult smokers report a desire to quit, but each year fewer than 1 in 10 are successful. The problem is just as prevalent in youth smokers. In 2019, 57.5% of middle and high schoolers reported they had tried to stop using tobacco products for one or more days over the past year.

Promising New Option

There are now more options for people who want to quit smoking. On August 24, 2020, BrainsWay Ltd announced the Food and Drug Administration approved the company's deep transcranial magnetic stimulation (TMS) system for use in helping adults quit smoking. BrainsWay’s device is the first TMS to be approved by the FDA for the treatment of addiction. The device has already been approved for the treatment of obsessive compulsive disorder and major depression.

Supporting Evidence

The FDA approved the BrainsWay Deep TMS system based on the results of a double-blind smoking cessation study. A total of 262 adults participated in the study. Participants had a history of smoking more than 26 years and had unsuccessfully tried to quit numerous times.

Method

Participants had active or sham treatments 5 days a week for 3 weeks, then 3 days a week for 3 weeks. Researchers collected data from participants’ answers to open-ended questions, personal daily logs and confirmatory urine samples.

Results

The four-week quit rate (CQR), representing a consecutive 4-week period of no smoking, was compared between the active and sham groups. Abstinence from smoking was determined through participant’s self report of no smoking, which were validated through urine tests. In participants who completed 4-weeks of treatment with confirmed abstinence, the CQR score was 28.4% compared to only 11.7% in the sham group. The number of cigarettes smoked per day was also lower in the active treatment group.

How it Works

Deep TMS works by sending repetitive magnetic pulses to stimulate nerve cells in the part of your brain that controls mood. The procedure is noninvasive, painless and is most commonly used to improve symptoms of depression when other therapies haven’t worked.

The BrainsWay Deep TMS system has 2 features that improves its effectiveness in treating nicotine addiction.

Reaches the deeper parts of the brain without lowering the intensity of the magnetic field.
Doesn’t require additional neuronavigation equipment because the magnetic field is able to better target a broader area of the brain.

What to Expect

The treatment begins with a padded helmet being placed on the patient’s head while they sit comfortably in a chair. The helmet sends out the magnetic pulses that stimulate neural activity within the affected part of the brain. The treatment is non-invasive, doesn’t require anesthesia and each session lasts around 20 minutes.

Side Effects

According to the study’s Co-PI, Dr. Mark S. George, research has shown Deep TMS to be a safe treatment that has no lasting or systemic side effects. The most common side effects experienced were headaches and discomfort at the application site. Headaches were generally described as mild and only occurred in approximately 5% of treatment sessions.

Safety Concerns

BrainsWay warns some patients should not participate in dTMS because of safety concerns, including

Individuals with magnetic metal plates or devices implanted in and around their head.
This does not include standard dental fillings
Individuals with implanted electronic devices in their body.
Individuals who have had a seizure or a medical condition that puts them at risk for having a seizure.

Here is a list of metal head implants, provided by John Hopkins Medicine, that may prevent someone undergoing deep TMS treatment:

Aneurysm repair clips or coils
Stents located in the neck or brain
Deep brain stimulators
Electrodes monitoring brain activity
Metallic eye or ear implants
Bullet fragments or shrapnel in or around your head
Facial or head tattoos with magnetic sensitive or metallic ink
Any other metal devices implanted in or near the head.

Treatment Sites

There are over 600 BrainsWay dTMS providers across the U.S, including hospitals, group practices and independent clinicians. To find a location near you, visit BrainsWay's location finder.

What Do You Think?

If brain stimulation helps with tobacco addiction, do you think it will help people overcome addictions to other substances?