Category: Service Details

Procedure

A NeuroStar Advanced Therapy TMS 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 NeuroStar Advanced Therapy TMS over an approximately 19-37 minute period. In 10-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 a 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 Advanced Therapy TMS 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 NeuroStar Advanced Therapy TMS, please click here.

Clinical trials have demonstrated the safety of NeuroStar Advanced Therapy® in treating patients who have had an inadequate response to prior antidepressant medications.

Treatment with NeuroStar Advanced 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 Advanced Therapy TMS due to adverse events.

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 Advanced Therapy TMS 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 Advanced Therapy TMS should not be used in patients with implants controlled by physiological signals. This includes pacemakers, implantable cardioverter defibrillators (ICDs), and vagus nerve stimulators (VNS).

Learn about a typical NeuroStar Advanced Therapy TMS treatment session.

Clinical trials have demonstrated the effectiveness of NeuroStar Advanced Therapy TMS in treating patients who have not benefited from prior antidepressant medication. NeuroStar Advanced Therapy TMS 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 Advanced Therapy TMS for 4 to 6 weeks, similar to real clinical context.¹

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 Advanced Therapy TMS were four times more likely to achieve remission compared to patients receiving a sham treatment. 1 in 2 patients experienced significant improvement in their depression symptoms and 1 in 3 experienced complete remission. Patients treated with NeuroStar Advanced Therapy 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 is the only TMS system with the durability of its effects established over 12 months.

In a trial with physician directed standard of care, meaning NeuroStar Advanced 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, 2 out of 3 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.¹

After the end of the treatment period, only 1 in 3 patients needed to come back for maintenance TMS sessions, or ‘reintroduction’ during this 12-month period.¹

Treatment Algorithm

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 Advanced 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 dose and duration in the current episode.

Please see the Treatment Algorithm for an effective illustration of the use of NeuroStar Advanced Therapy TMS early on in the treatment of depression.

NeuroStar Advanced Therapy has not been studied in patients who have not received prior antidepressant treatment.

View TMS Therapy safety data

TMS+YOU is an online community and national patient advocacy site for TMS Therapy. Those considering Transcranial Magnetic Stimulation can connect with patients who have had the treatment to answer questions, share insights, and get the latest information.

References:

Carpenter LL, et al. (2012). Depress Anxiety, 29(7):587-596.

NeuroStar Advanced Therapy is the first non-systemic and non-invasive outpatient depression treatment cleared by the US Food and Drug Administration (FDA) for patients who have not benefited from prior antidepressant treatment. NeuroStar Advanced Therapy TMS uses highly focused, pulsed magnetic fields to stimulate function in targeted brain regions.

NeuroStar Advanced Therapy TMS 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.

Learn more about this non-drug depression treatment

TMS+YOU is an online community and national patient advocacy site for TMS Therapy. Those considering Transcranial Magnetic Stimulation can connect with patients who have had the treatment to answer questions, share insights, and get the latest information.

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 19-37 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.

Is NeuroStar TMS therapy covered by my insurance?

It usually takes time for healthcare insurers to establish coverage policies for newly approved treatments such as NeuroStar 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.

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, 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 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 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 19-37 minutes sessions, depending on what the doctor determines is the correct protocol, 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.