What is TMS Therapy?
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 37 minutes daily over 4-6 weeks.
How does TMS Therapy work?
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.
Does NeuroStar TMS therapy have negative side effects?
NeuroStar® 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.
Is TMS Therapy like other alternative therapies which use magnets to treat some illnesses?
No. TMS Therapy 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.
Is TMS Therapy like electroconvulsive therapy (ECT)?
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 TMS Therapy, patients sit in a chair and are awake and alert throughout the entire 37-minute procedure – no sedation is used with TMS Therapy. Patients can transport themselves to and from treatment. In over 10,000 active treatments with the NeuroStar TMS Therapy system in clinical trials, no seizures were observed. TMS Therapy 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.
What is a typical course of treatment with NeuroStar TMS Therapy?
A typical course of TMS Therapy is 5 times per week for 37 minutes sessions over 4-6 weeks. Any additional treatments are based on clinical judgment.
What are the potential risks of NeuroStar TMS Therapy?
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.
Can NeuroStar TMS Therapy cause brain tumors?
No, NeuroStar TMS 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 TMS Therapy is a small fraction of just one brain scan with an MRI.
Does TMS Therapy cause memory loss?
No, the NeuroStar TMS Therapy system was systematically evaluated for its effects on memory. Clinical trials demonstrated that NeuroStar TMS Therapy does not result in any negative effects on memory or concentration.
Is TMS Therapy uncomfortable?
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 TMS Therapy discontinued treatment due to side effects.
How long does the antidepressant effect last? Will I need any therapy beyond the first treatment regimen?
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.
Can I also take antidepressant(s) if I am receiving NeuroStar TMS Therapy?
Yes. In clinical trials, NeuroStar TMS Therapy was safely administered with and without other antidepressant medications.
Does FDA-clearance of the NeuroStar TMS Therapy system mean that all TMS devices are cleared for use in major depression within the United States?
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.