- What is TMS Therapy?
TMS stands for transcranial magnetic stimulation. It is used to treat depression by stimulating the brain non-invasively using an electromagnetic field, similar to those magnetic fields produced by an MRI machine. During TMS Therapy, a magnetic field is administered in very short pulses to the part of your 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 differently in patients with depression. The magnetic field produces an electric current in the brain that stimulates the brain cells (neurons). This results in changes in the brain that are thought to be beneficial in the treatment of depression.
- Is TMS Therapy a good alternative for patients who cannot tolerate the side effects associated with antidepressant medications?
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, among others that are commonly found with antidepressant drugs. The most common side effects reported with NeuroStar® TMS during clinical trials were headache and scalp pain or discomfort – generally mild to moderate – occurring less frequently after the first week of treatment. NeuroStar® TMS Therapy is cleared by the U.S. Food and Drug Administration (FDA) for the treatment of patients with depression who have failed to achieve satisfactory improvement from prior antidepressant medication. TMS Therapy may not work for all patients with depression. You should speak with your doctor to determine if TMS Therapy is an appropriate treatment option for you.
- 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 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 the TMS Therapy procedure, 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 NeuroStar® TMS Therapy in clinical trials, no seizures were observed. TMS Therapy was also shown to have no negative effects on memory function in clinical studies. However, there is a remote risk of seizure with TMS Therapy. 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 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?
In clinical trials, patients received NeuroStar® TMS Therapy 5 times per week for 37 minutes sessions over 4-6 weeks. Patients treated with NeuroStar® TMS Therapy are likely to receive treatment for a minimum of four weeks with additional treatments based on clinical judgment.
- What are the potential risks of NeuroStar® TMS Therapy?
NeuroStar® TMS Therapy is well tolerated and has been proven 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 were scalp pain or discomfort during treatment sessions. These side effects were 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 proven 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.
- Who should not receive NeuroStar® TMS Therapy?
NeuroStar® TMS Therapy should not be used (is contraindicated) in patients with implanted metallic devices or non-removable metallic objects in or around the head. NeuroStar® TMS Therapy should be used with caution in patients with implanted devices that are controlled by physiological signals. This includes pacemakers and implantable cardioverter defibrillators (ICDs). It should be used in caution with patients using wearable cardioverter defibrillators.
- Does 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 NeuroStar® cause memory loss?
No, NeuroStar® TMS Therapy 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?
The most common side effect related to treatment is scalp pain or discomfort during treatment sessions — generally mild to moderate. 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 4-6 weeks?
In most patients, the clinical benefit of NeuroStar® TMS Therapy was maintained through 6 months of follow-up study. Talk to your doctor about your long-term treatment path.
- 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 can be used to treat major depression within the United States?
No, the NeuroStar® TMS Therapy system is the first and only 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 and only TMS device to have been evaluated in a large, multicenter, controlled clinical trial for the treatment of depression.No other TMS device can claim to be “FDA-cleared” for the treatment of depression. These devices have not been proven to be safe and effective for treating depression.
