TMS THERAPY
FDA-cleared, non-medication depression treatment
Non-Drug Depression Treatment Rapidly and Significantly Improves Disease Symptoms and Quality of Life
- Percentage of Patients Reporting a Return to Normal Activities More Than Tripled Following Treatment with NeuroStar TMS Therapy® - PHILADELPHIA, May 8, 2012 – New data released today at the annual meeting of the AmericanPsychiatric Association show that patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving transcranial magnetic stimulation (TMS) with NeuroStar TMS Therapy® achieved significant improvements in both depression symptoms and in quality of life measurements. Overall, 58 percent of patients achieved a positive response to NeuroStar TMS therapy, with 37 percent of patients achieving remission from their depression.After an average of five weeks of NeuroStar treatment, the percentage of patients reporting extreme problems with anxiety and depression decreased by 42.2 percent, demonstrating a reduction in depression symptomatology. For overall treatment effect, the percentage of patients reporting no problems in performing usual activities improved
─ Percentage of Patients Reporting a Return to Normal Activities More Than Tripled Following Treatment with NeuroStar TMS Therapy® ─
PHILADELPHIA, May 8, 2012 – New data released today at the annual meeting of the AmericanPsychiatric Association show that patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving transcranial magnetic stimulation (TMS) with NeuroStar TMS Therapy® achieved significant improvements in both depression symptoms and in quality of life measurements. Overall, 58 percent of patients achieved a positive response to NeuroStar TMS therapy, with 37 percent of patients achieving remission from their depression.After an average of five weeks of NeuroStar treatment, the percentage of patients reporting extreme problems with anxiety and depression decreased by 42.2 percent, demonstrating a reduction in depression symptomatology. For overall treatment effect, the percentage of patients reporting no problems in performing usual activities improved by 30.5 percent.”The improvements we observed show that non-drug therapy with NeuroStar TMS not only reduces the symptomatic suffering of patients, but lessens the disability of depression with important implications for these individuals’ ability to return to functioning effectively at home, in the workplace, and in the community,” said Ian A. Cook, M.D., Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles.
In the open label study, which involved 307 patients receiving acute treatment with NeuroStar TMS, patients experienced statistically-significant improvement across physical and mental variables as measured by the Short Form 36-Item Questionnaire (SF-36). The SF-36 is a multi-purpose, short-form health survey that evaluates functional health and well-being of disease among eight variables including physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. After five weeks of acute TMS therapy, the most drastic improvement was seen in the mental component summary score, which more than doubled from 16.6 prior to therapy to 33.5 after therapy.
Similarly, self-reported quality of life measures significantly improved with TMS therapy compared to baseline according to the EuroQol Questionnaire (EQ-5D), a standardized instrument that was used to evaluate the effect of TMS therapy on the quality of life of patients. At the end of acute treatment with TMS, the greatest improvements in EQ-5D dimensions were observed among patients who indicated no problems with “usual activities” (14.3 percent pre-TMS vs. 44.8 percent post-TMS), “anxiety/depression” (1.6 percent pre-TMS vs. 30.1 percent post-TMS) and “pain/discomfort” (39.4 percent pre-TMS vs. 52.8 percent post-TMS). In other EQ-5D dimensions, 81.8 percent of patients reported no problems with “mobility” following TMS treatment vs. 68.7 percent at baseline; 87.1 percent of patients reported no problems with “self-care” following TMS treatment vs. 72.6 percent at baseline.
“These data reinforce the clinical efficacy of TMS Therapy as a viable option for patients living with major depression who have not achieved or maintained symptom improvement with oral antidepressants,” said H. Brent Solvason, M.D., Stanford University Medical Center. “The most meaningful takeaway for patients is that TMS Therapy has the potential to make them feel better, in addition to potentially allowing them to experience a level of physical and social functionality they haven’t had with their depression.”
About Transcranial Magnetic StimulationTMS is a non-invasive, non-systemic therapeutic device that delivers magnetic resonance imaging (MRI)-strength, pulsed, magnetic fields to induce an electronic current in a localized region of the cerebral cortex, the part of the brain that controls mood. NeuroStar TMS Therapy is the first and only TMS therapy for major depressive disorder cleared by the U.S. Food and Drug Administration that has been proven to achieve remission without systemic side effects in patients who have not found relief with antidepressant medication.About Depression
Depression is a serious illness that affects about 20 million Americans annually. People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiousness, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems. It is estimated that about 4 million patients do not benefit from standard treatments for depression, even after repeated treatment attempts.
About the Study
The clinical trial was a multi-site, naturalistic, observational study involving 307 patients receiving acute treatment with TMS therapy across 43 clinical practices. All treatments were initiated using the NeuroStar TMS Therapy® System (Neuronetics, Inc., Malvern, PA, USA). The study is posted on www.clinicaltrials.gov, listing number NCT 01114477
About NeuroStar TMS Therapy®
Neuronetics’ NeuroStar TMS Therapy System was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder. NeuroStar TMS Therapy is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation. It stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly- focused MRI-strength magnetic field pulses. The treatment is typically administered daily for 4-6 weeks. For full safety and prescribing information, visit www.NeuroStar.com.
About Neuronetics
Neuronetics, Inc. is a privately-held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses. Based in Malvern, PA, Neuronetics is the leader in the development of TMS Therapy, a non-invasive form of neuromodulation. Neuronetics was created as a spin-out of The Innovation Factory, a medical device incubator in Duluth, GA. For more information, please visit www.neuronetics.com.
NeuroStar®, NeuroStar TMS Therapy®, and TMS Therapy®are registered trademarks of Neuronetics, Inc.
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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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