NeuroStar Advanced TMS Therapy, is a treatment for depression. This is a non-invasive, non-drug, FDA approved, outpatient procedure which uses a pulsed magnetic field to stimulate function in brain regions known to affect mood.
NeuroStar Advanced TMS Therapy is performed in a psychiatrist’s office under their supervision while the patient remains awake and alert.
NeuroStar Advanced Therapy is available by prescription only. It is not for everyone with depression, so patients should consult a NeuroStar doctor to determine this.
TMS therapy is well tolerated, and treatment is less than 19 minutes, 5 days a week for 4-6 weeks.
Clinical trials have demonstrated the effectiveness of NeuroStar TMS Therapy in treating patients who have not benefited from prior antidepressant medication. NeuroStar TMS Therapy was studied in adult patients suffering from Major Depressive Disorder, all of whom had not received satisfactory improvement with previous treatments.
An Effective and Durable Option for Treating Major Depressive Disorder
In an independent, randomized, controlled trial funded by the National Institute of Mental Health, 307 patients were treated with the NeuroStar TMS System for four to six weeks, similar to real clinical context.
Patients were divided into two groups:
Low Treatment Resistance: Patients who have failed to improve their depression symptoms after a single antidepressant treatment of adequate dose and duration.
High Treatment Resistance: Patients who have failed to improve their depression symptoms after a multiple (2-14) antidepressant treatments of adequate dose and duration.
At the end of their treatments, patients who had received NeuroStar TMS Therapy were four times more likely to achieve remission compared to patients receiving a sham treatment. One in two patients experienced significant improvement in their depression symptoms and one in three experienced complete remission. Patients treated with the NeuroStar TMS System also experienced significant improvement in anxiety and physical symptoms (such as appetite changes, aches and pains, and lack of energy) associated with depression.
Durability of TMS Treatments
NeuroStar TMS is the only TMS system with the durability of its effects established over 12 months.
In a trial with physicians directed standard of care, meaning NeuroStar TMS Therapy could be used in conjunction with antidepressants as needed, patients who had received treatment then reported their symptom levels at 3,6,9, and 12 months to determine the durability of their treatments. By the end of the 12-month period, two out of three patients who had either responded or completely remitted after TMS treatment remained at the symptom levels they reported at the end of the treatment phase.
After the end of the treatment period, only one in three patients needed to come back for maintenance TMS sessions, or ‘reintroduction’ during this 12-month period.
Additionally, Neuronetics has developed a new tool to use in educating patients on the best practices of treating depression. The Best Practices Treatment Guideline for Depression has been developed to help patients understand TMS Therapy as an option if their first line antidepressant medications stop working. This guideline is based on the 2010 American Psychiatric Association’s practice guidelines and NeuroStar TMS Therapy indication for use, which says:
NeuroStar TMS Therapy is indicated for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication at or above the minimal effective does and duration in the current episode.
Please see the Treatment Algorithm for an effective illustration of the use of NeuroStar TMS Therapy early on in the treatment of depression.
NeuroStar TMS has not been studied in patients who have not receieved prior antidepressant treatment.
Carpenter LL, et al. (2012). Depress Anxiety, 29(7):587-596.
Clinical trials have demonstrated that safety of NeuroStar TMS Therapy in treating patients who have had an inadequate response to prior antidepressant medications.
Treatment with NeuroStar TMS Therapy caused very few side effects and was generally well tolerated by patients. The most common side effect reported during clinical trials was scalp discomfort – generally mild to moderate and occurring less frequently after the first week of treatment.
Fewer than 5% of patients discontinued treatment with NeuroStar TMS Therapy due to adverse events.
Over 10,000 active treatments were preformed across all NeuroStar clinical trials demonstrating its safety.
No systemic side effects
No weight gain
No sexual dysfunction
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.
NeuroStar TMS Therapy should not be used in patients with implants controlled by physiological signals. This includes pacemakers, implantable cardioveter defibrillators (ICDs), and vagus nerve stimulators (VNS).
Click here to learn about a typical NeuroStar TMS Therapy treatment session.
Janicak, P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal of Clinical Psychiatry, February 2008.
A NeuroStar TMS Therapy treatment session is a short outpatient procedure that lasts about 19-37 minutes, depending on what the doctor determines is the correct protocol. During treatment, you can relax in the treatment chair. You can also speak with our TMS Specialists whenever necessary. After the procedure, you can immediately return to your normal routine, including driving.
Your first treatment session
Because your TMS-certified physician needs to determine how to most effectively administer treatment, your first session could last up to an hour and a half. You will be provided and asked to wear protective earplugs, as the system emits a tapping sound during operation.
Your TMS physician will first perform a test to identify your motor threshold. The motor threshold is the amount of magnetic field strength that results in a movement of your right thumb. This test is important because it identifies the magnetic field strength that will be used in your treatment. This field strength is customized for each patient to deliver the correct treatment dose.
After this initial procedure, the TMS physician will determine the place on the head where the TMS treatment will be applied and the magnetic coil will be moved to that location. This will allow you to receive optimal treatment.
The TMS Specialist will then administer TMS Therapy over an approximately 19-40 minute period. In 30-second intervals, the device will deliver rapid "pulses" of the magnetic fields. These will feel like tapping on your scalp. Some patients may find this tapping uncomfortable. Your physician may be able to make adjustments to reduce this discomfort.
After the procedure
Immediately following each treatment session, you may return to your normal daily routine, including driving. During or after treatment you may experience headache or discomfort at the site of stimulation. These are common side effects that often improve as further treatment sessions are administered. If necessary, you can treat this discomfort with an over-the-counter analgesic. If these side effects persist, your TMS physician can temporarily reduce the strength of the magnetic field pulses being administered in order to make treatment more comfortable.
In clinical trials, most patients who benefited from NeuroStar TMS Therapy experienced results by the fourth week of treatment. Some patients may experience results in less time, while others may take longer. You should discuss your depression symptoms with your physician throughout the treatment course. If symptoms persist, you may want to consider other antidepressant options.
TMS Therapy Insurance Coverage
Since the FDA clearance of TMS in 2008, insurance coverage for eligible patients has increased significantly. Currently, there are over 60 coverage polices for TMS, including most Medicare contractors. Although TMS is not a first line of treatment, it is an alternative option for those who are not responding to or cannot tolerate medications. Patients are encouraged to speak directly with their Doctor regarding any specific insurance questions. Patients can also contact a Reimbursement Specialist and receive assistance with understanding insurance coverage and verifying insurance benefits. For a list of the insurance companies and applicable states that cover TMS Therapy, please click here.
Click here to learn about NeuroStar Advanced Therapy.
Frequently Asked Questions
How does TMS work?
The Neurostar system uses short pulses of magnetic fields to stimulate the area of the brain that is thought to function abnormally in patients who suffer from depression. An electronic current is created by the magnetic field, which stimulates the brain cells.
Neurostar TMS is covered by many commercial and Medicare plans. Please click here to see if your insurance qualifies.
Is TMS Therapy a good alternative for patients who cannot tolerate the side effects associated with antidepressant medications?
NeuroStar 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.
Is TMS Therapy uncomfortable?
No, the most frequent side effect associated to treatment is scalp discomfort during treatment sessions. This side effect has been reported to decrease after the first week of treatment.
You can treat the scalp discomfort with over-the-counter medicine. If the side effects continue, your physician can temporarily reduce the strength of magnetic field pulses being used.
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 being used in a MRI. These techniques differ radically from the popular use of low intensity, static magnetic fields.
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 19-37 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 even a few hours after 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 five times per week for 19-37 minutes sessions, depending on what the doctor determines is the correct protocol, over four to six 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.
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, two out of three 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 one in three 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.