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FDA Clears TMS System for Anxiety Symptom Relief
Daniel Hageman
2021-11-23T22:58:40Z
Medically reviewed on by
Regional Medical Director Greater St. Louis
FDA Clears TMS System for Anxiety Symptom Relief
Prospective patients often ask us, “Is TMS FDA approved for anxiety?” Until recently, the answer was a straightforward no. But in an exciting development, the U.S. Food and Drug Administration (FDA) cleared the use of BrainsWay’s deep Transcranial Magnetic Stimulation™ (TMS) system to help alleviate symptoms of anxiety in people with major depressive disorder.
This is welcome news for the millions of people who have struggled with the common co-occurrence of depression and anxiety, especially for those who haven’t found relief with other treatment methods, such as medication or talk therapy.
Distinctions Between Depression and Anxiety
TMS has been FDA-cleared for treatment of major depressive disorder since 2008. It’s important to note that this new ruling approves the use of BrainsWay deep TMS to treat anxiety in people with depression, not an anxiety disorder itself. As far as we know, TMS is not effective for anxiety disorders by themselves.
Anxiety and depression can be interlinked, possibly because both conditions are impacted by low levels of the brain neurotransmitter serotonin. Anxiety is very common in depressed patients. For those suffering from depression, more than half have at least moderate anxiety, and many have severe anxiety. Similarly, patients with anxiety disorders often also have depression.
If you’re someone who is experiencing symptoms in both categories, it’s critical to get a diagnosis to ensure the proper treatment plan is put in place to address anxiety and depression.
Depression and Anxiety Treatment Cases of co-occurring depression and anxiety can be treated with medications and therapeutic intervention as a starting point. Either modality can be used on its own, or in combination with each other.
Cognitive behavioral therapy (CBT) is perhaps the most common form of talk therapy used for anxiety and depression treatment. A CBT therapist helps patients examine their negative beliefs and thought patterns, giving them the necessary tools to replace those feelings with more positive behaviors. Dialectical behavioral therapy (DBT) may also be recommended for people with co-occurring anxiety and depression. This is an offshoot of CBT that believes patients must accept their negative patterns as part of life, and by accepting those challenges they can move towards change. Also, DBT coping mechanisms can be used when a patient is in emotional or physical distress.
Medications are the other common component of a treatment plan. Selective serotonin reuptake inhibitors (SSRIs) are antidepressants that can also be used to manage anxiety symptoms. Typical SSRIs include sertraline (Zoloft®), fluoxetine (Prozac®), and paroxetine (Paxil®).
Other antidepressants used for depression and anxiety include serotonin-norepinephrine reuptake inhibitors (SNRIs) and tricyclics. Duloxetine (Cymbalta®) is an example of an SNRI, while amitriptyline (Elavil®) is a type of tricyclic. Anxiety medications also include buspirone or benzodiazepines such as Xanax®. Prescription medications for depression include monoamine oxidase inhibitors (MAOIs) such as phenelzine (Nardil®).
Sometimes, however, medication and talk therapy don’t deliver the desired results. The new FDA clearance for the BrainSway TMS system indicates the promise TMS holds for people with depression who are seeking relief from anxiety symptoms. The data submitted to the FDA analyzed the results of 573 people across three randomized controlled trials and 11 studies where people had undergone deep TMS. According to the
FDA report granting the clearance, BrainsWay’s deep TMS system produced “consistent, robust and clinically meaningful” results when compared to medication or placebo treatment.
Contact Us for TMS Treatment Today
TMS is an effective treatment option for depression, as well as for obsessive compulsive disorder (OCD) and smoking cessation. Magnetic technology is the foundation for how TMS works. With an electromagnetic coil placed precisely on the scalp, near the left temple, magnetic pulses turn into gentle electrical currents that stimulate targeted areas of the brain.
Proper brain function is restored and symptoms are alleviated during a course of treatment, which is typically every weekday for several weeks, and then less frequent toward the end of treatment. Each session lasts from 18 to 40 minutes. TMS is non-invasive, no drugs are involved and side effects are minimal, so you can drive yourself to and from treatment and keep up with your normal schedule. Talk with us to find out if TMS is right for you or a loved one.
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You may feel isolated and alone when you have clinical depression, and depression also affects your relationships with family and friends. While the primary focus of your treatment is to improve your mental health, it’s also essential to understand your loved ones may experience their own issues as they try to support you. An understanding of how depression affects relationships can help everyone maintain healthy connections and navigate problems. Here are some of the ways depression may affect the people in your support network.
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Starting any medical treatment for the first time can leave you with questions, especially if you’re looking forward to the benefits it may bring. It’s no different when you’re preparing for your nasal esketamine treatment. Your previous mental health treatments may have consisted solely of taking antidepressants at home or visiting a therapist’s office for cognitive behavioral therapy (CBT), so nasal esketamine is probably a new treatment experience for you. If you're wondering what it's like to start nasal esketamine and get ready for your first session, keep reading. Getting Started with the Nasal Esketamine Treatment As with any new treatment, you’ll first talk to your primary care provider or psychiatrist about whether nasal esketamine is a good fit for you. Alternatively, you can schedule your esketamine nasal spray consultation with a treatment center (such as Greenbrook) that has certification by the FDA’s Risk Evaluation and Mitigation Strategy (REMS). At Greenbrook's REMS-certified nasal esketamine treatment centers, our Greenbrook-affiliated psychiatrists and psychiatric nurse practitioners will review your medical history and also conduct our own assessment to help determine whether nasal esketamine treatment is right for you. Certain conditions, including blood vessel disease and a history of psychosis, may make treatment a risk for you. Make sure you discuss all previous and present conditions with your doctor or nasal esketamine provider before beginning treatment. If the medication is deemed a good fit, you’ll receive your prescription from the Greenbrook-affiliated provider. Your Greenbrook Care Team will put together a personalized care plan for the weeks and months to follow. Keep in mind that you will need to take a standard (oral) antidepressant along with your nasal esketamine treatment. There are two important regulations to note when it comes to preparing for treatment: Each treatment is followed by a mandatory two-hour observation period. This means you will need to plan to stay at the center for at least two hours following your self-administration of the esketamine nasal spray. You cannot drive during the rest of the day after treatment and must arrange for transportation. These regulations are mandatory. It may be helpful to sit down and plan out several weeks’ worth of transportation once you know your treatment schedule. In addition, if you’re wondering what to bring for the treatment, we recommend entertainment such as an audiobook or playlist of favorite songs and a pair of headphones. You may want them during the two-hour observation period. What to Expect During Nasal Esketamine Treatment On the day of treatment, you’ll need to stop eating any food two hours before your appointment and stop drinking all fluids 30 minutes before you come in. Your Greenbrook Care Team will confirm that you are prepared for the two-hour observation period and that you have a ride home. You’ll get the opportunity to practice using a “trainer sprayer” that mimics the real nasal esketamine sprayer but does not release any medication. The Care Team will encourage you to use the restroom and set up your preferred environment in your private treatment bay or room. Some patients like reduced lighting, for example, while others don’t request light adjustments. You’ll complete a depression scale before each treatment session. Your Greenbrook provider will confirm that the dose kit is yours, show you how to administer it, and then hand it to you. Each sprayer contained 28mg of Spravato esketamine nasal spray. Patients usually start with two sprayers (56mg) and soon increase to 84mg (three sprayers) per treatment. But, your dosage maybe vary. Should you be left with a metallic taste by the spray, the Care Team will offer suckers to help make the flavor dissipate. After your dose, you’ll be encouraged to lie back in your comfortable recliner. While most patients enjoy a quiet setting, Greenbrook is prepared to accommodate patients with a more animated reaction to the medication. You may feel sleepy, dizzy, mildly dissociated, and/or nauseated during treatment. Greenbrook's Care Team is readily available if you need assistance. How to Prepare for after your Nasal Esketamine Treatment Most side effects begin to wane in the second hour of observation, but if you’re wondering, “Is it safe to drive immediately after nasal esketamine treatment?” the answer is a resounding no. In addition to the mandatory ride home, you will need to block off time to rest and let side effects fully dissipate. This extended rest period is especially important in the first weeks of treatment when you’ll have treatment twice a week. Do not drive or operate machinery of any kind until the day after treatment. Just take it easy, relax, and take care of yourself. If you’re unsure what activities you can do or should avoid during this time, talk to your Care Team for more information. While side effects tend to dissipate completely after a good night’s sleep, many nasal esketamine patients begin feeling relief from depression symptoms within hours of their treatment. Other Tips in Preparing for Your Nasal Esketamine Treatment At Greenbrook, we make every effort to schedule your treatment in the afternoons or whenever it is most convenient for you. We encourage you to see each treatment session as an opportunity to relax and take care of your mental health. If you have any questions or concerns, talk to your doctor or the Greenbrook Care Team. At Greenbrook, we’ll help you feel at ease when preparing for each treatment session. Schedule A Free Consultation To get started with nasal esketamine, schedule your free consultation today.
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