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 7 weeks.
The NeuroStar Advanced 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.
It usually takes time for healthcare insurers to establish coverage policies for newly approved treatments such as NeuroStar Advanced Therapy TMS. However, many commercial and Medicare plans have recognized the effectiveness of treating depression with TMS Therapy and now cover TMS as part of their plans. See here for a full list of insurance plans that cover TMS.
NeuroStar® Advanced Therapy is non-systemic (does not circulate in the blood throughout the body), so it does not have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc. The most common side effects reported during clinical trials were headache and scalp discomfort – generally mild to moderate – occurring less frequently after the first week of treatment.
No. NeuroStar Advanced Therapy TMS involves a unique method of using pulsed magnetic fields for therapeutic benefit. The intensity of the magnetic field is similar to that of the magnetic fields used in magnetic resonance imaging, or MRI. These techniques differ radically from the popular use of low intensity, static magnetic fields. These products deliver weak and undirected static fields that are not capable of activating brain cells.
No, the two procedures are very different. While both are effective in the treatment of depression, there are many differences in safety and tolerability.
During NeuroStar Advanced Therapy TMS, patients sit in a chair and are awake and alert throughout the entire 19-37 minute procedure – no sedation is used with NeuroStar Advanced Therapy TMS. Patients can transport themselves to and from treatment.
In over 10,000 active treatments with the NeuroStar Advanced Therapy system in clinical trials, no seizures were observed. NeuroStar Advanced Therapy TMS was also shown to have no negative effects on memory function in these studies.
In contrast, “shock therapy,” or electroconvulsive therapy (ECT), intentionally causes a seizure. Patients receiving ECT must be sedated with general anesthesia and paralyzed with muscle relaxants. Recovery from an ECT treatment session occurs slowly, and patients are usually closely monitored for minutes or a even few hours after a treatment.
Short-term confusion and memory loss are common with ECT, and long-term disruptions in memory have been shown to occur and may persist indefinitely in some people. Because of the side effects associated with ECT, a significant amount of caregiver support is required.
A typical course of NeuroStar Advanced Therapy TMS is 5 times per week for 19-37 minutes sessions, depending on what the doctor determines is the correct protocol, over 7 weeks.
Any additional treatments are based on clinical judgment.
NeuroStar Advanced Therapy has been shown to be well tolerated and the Neurostar Advanced 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 Advanced 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 Advanced 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.
No, NeuroStar Advanced Therapy uses the same type and strength of magnetic fields as MRIs (magnetic resonance imaging), which have been used in tens of millions of patients around the world and have not been shown to cause tumors. The magnetic energy used in a full course of NeuroStar is a small fraction of just one brain scan with an MRI.
No, the NeuroStar Advanced Therapy system was systematically evaluated for its effects on memory.
No, the most common 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.
If necessary, you can treat this discomfort with an over-the-counter analgesic. If these side effects persist, your doctor can temporarily reduce the strength of the magnetic field pulses being administered in order to make treatment more comfortable.
Less than 5% of patients treated with NeuroStar Advanced TMS Therapy discontinued treatment due to side effects.
NeuroStar Advanced Therapy 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 Advanced Therapy TMS was safely administered with and without other antidepressant medications.
No, the NeuroStar Advanced Therapy TMS system is the first TMS device to be cleared by the U.S. Food and Drug Administration (FDA) for the treatment of major depression.
TheNeuroStar Advanced Therapy TMS 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.
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Indication
NeuroStar Advanced Therapy is only available by prescription. A doctor can help decide if NeuroStar Advanced Therapy is right for you. Patients’ results may vary. The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). Visit neurostar.com for full safety and prescribing information.
Important Safety Information
The most common side effect is pain or discomfort at or near the treatment site. These events are transient; they occur during the TMS treatment course and do not occur for most patients after the first week of treatment. There is a rare risk of seizure associated with the use of TMS therapy (<0.1% per patient). NeuroStar Advanced Therapy should not be used with patients who have non-removable conductive metal in or near the head. NeuroStar Advanced Therapy has not been studied in patients who have not received prior antidepressant treatment.