For decades, researchers have sought safe and effective treatments for depression. However, there is no single depression treatment which has been proven to work for everyone. Depression is often treated with antidepressant medications; however, alternative treatments for depression are available. These depression therapies have been shown to work in people who do not receive benefit from medications or cannot tolerate the side effects caused by them. One alternative therapy for the treatment of depression is transcranial magnetic stimulation (TMS). NeuroStar TMS Therapy was recently FDA-cleared for patients suffering from depression who have not achieved satisfactory improvement from prior antidepressant medications.
Transcranial magnetic stimulation therapy uses short pulses of magnetic fields to stimulate nerve cells in the area of the brain thought to control mood. It is sometimes referred to as rTMS which stands for repetitive transcranial magnetic stimulation. TMS patients receiving TMS Therapy remain awake and alert during the procedure. NeuroStar TMS Therapy ® is an outpatient procedure. The typical treatment course consists of at least 5 treatments per week over a 4-6 week period for 20-30 treatments. Each depression treatment session lasts approximately 19-37 minutes, depending on what the doctor determines is the correct protocol. NeuroStar TMS
Therapy is:
Non-invasive, meaning that it does not involve surgery. It does not require any anesthesia or sedation, as the patient remains awake and alert during the treatment. Non-systemic, meaning that it is not taken by mouth and does not circulate in the bloodstream throughout the body. FDA has cleared TMS for patients who have not benefited from prior antidepressant treatment. Over 10,000 active treatments were performed across all NeuroStar® clinical trials demonstrating its safety1
No systemic side effects
No weight gain
No sexual dysfunction
No sedation
No nausea
No dry mouth
No adverse effects on concentration or memory
No drug interactions
NeuroStar TMS Therapy should not be used in patients with implanted metallic devices or non-removable metallic objects in or around the head. This does not include metallic fillings in teeth.
TMS stands for transcranial magnetic stimulation. It is used to treat depression by stimulating the brain non-invasively using electromagnetic fields, similar to those produced by an MRI machine. During TMS Therapy, a magnetic field is administered in very short pulses to the part of the brain that research has demonstrated to be associated with depression. The typical initial course of treatment is about 19-37 minutes daily over 4-6 weeks.
The NeuroStar TMS Therapy system uses short pulses of magnetic fields to stimulate the area of the brain that is thought to function abnormally in patients with depression. The magnetic field produces an electric current in the brain that stimulates the brain cells (neurons). This results in changes that are thought to be beneficial in the treatment of depression.
A typical course of TMS Therapy is 5 times per week for 19-37 minute sessions, depending on what the doctor determines is the correct protocol, over 4-6 weeks. Any additional treatments are based on clinical judgment.
NeuroStar TMS Therapy has been shown to be well tolerated and the Neurostar TMS Therapy system has been demonstrated to be safe in clinical trials. Throughout over 10,000 active treatments performed in clinical trials, the most commonly reported side effect related to treatment was scalp discomfort during treatment sessions. This side effect was generally mild to moderate, and occurred less frequently after the first week of treatment. Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment due to side effects. In NeuroStar clinical trials, over 10,000 TMS treatments demonstrated its safety, with no occurrence of seizures. However, there is a small risk of a seizure occurring during treatment. This risk is no greater than what has been observed with oral antidepressant medications. While NeuroStar TMS Therapy has been demonstrated to be effective, not all patients will benefit from it. Patients should be carefully monitored for worsening symptoms, signs or symptoms of suicidal behavior, and/or unusual behavior. Families and caregivers should also be aware of the need to observe patients and notify their treatment provider if symptoms worsen.
NeuroStar TMS is the only TMS system with the durability of its effects established over 12 months. In a clinical trial, 2 out of 3 patients who had either responded to treatment or completely remitted their depression symptoms reported 12 months later that they remained at the level they were at the end of the trial. Additionally, after the trial, only 1 in 3 patients needed to return for 'maintenance' TMS sessions.
Yes. In clinical trials, NeuroStar TMS Therapy was safely administered with and without other antidepressant medications.
No, the NeuroStar TMS Therapy system is the first TMS device to be cleared by the U.S. Food and Drug Administration (FDA) for the treatment of major depression. The NeuroStar TMS Therapy system is also the first TMS device to have been evaluated in a large, multicenter, controlled clinical trial, as well as the only TMS system with the durability of its effects over 12 months established.
