FAQ - Frequently Asked Questions about TMS Therapy

• The NeuroStar TMS Therapy system is the first and only TMS Therapy^® device cleared by the FDA for the treatment of depression.

• TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation, which stimulates nerve cells in an area of the brain that is linked to depression, by delivering highly focused MRI-strength magnetic pulses.

• Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert.

• It is a 37-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist’s office.

• The treatment is typically administered daily for 4-6 weeks.

• During NeuroStar TMS Therapy, pulsed magnetic fields are repetitively transmitted into the left prefrontal cortex, the part of the brain that is thought to regulate mood, in order to stimulate the firing of neurons (nerve cells).

• This is believed to trigger a cascade of neurochemical events, including the release of neurotransmitters (such as serotonin, norepinephrine, and dopamine) and to help normalize neurotransmitter function.

• In clinical trials, patients received NeuroStar TMS Therapy 5 times per week for 37 minutes each session for 4-6 weeks.
• Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgment.

• NeuroStar TMS Therapy is the first and only non-systemic and non-invasive depression treatment to be cleared by the FDA for the treatment of depression

• It is indicated for adult patients who did not achieve satisfactory improvement from prior antidepressant medication in the current depressive episode.

• Median of 4 treatment attempts, 1 of which was adequate in dose and duration

• In clinical trials, 1 in 2 patients had significant improvement in symptoms and 1 in 3 had complete symptom resolution

• It is non-systemic, which means it does not have side effects such as weight gain, sexual dysfunction, nausea, sedation, or dry mouth.

During the six-month maintenance of effect study with NeuroStar TMS Therapy, patients were maintained on antidepressant monotherapy and received periodic NeuroStar TMS Therapy for symptom worsening. During this study:

• For patients previously treated with NeuroStar TMS Therapy,less than 10% relapsed at the end of 6 months
• Approximately half of the patients experienced symptom breakthrough and required TMS Therapy re-treatment

• Comparison of NeuroStar TMS and AD medication efficacy can be done using statistical methods that permit valid cross-study comparisons . These methods show that NeuroStar TMS Therapy efficacy compares favorably with that of current antidepressant medication treatment options; however, NeuroStar TMS has not been compared in head-to-head studies with antidepressant medications.

• Trials to compare NeuroStar TMS vs. drugs have not been performed because these treatment are directed towards patient populations that differ in their level of “treatment resistance", which means how many times they received antidepressant medication and did not receive benefit.

  + The patients for which NeuroStar has been FDA-cleared had failed multiple antidepressant treatment attempts, one of which achieved an adequate dose and duration

  + Almost all antidepressant medications have been studied for 1st-line treatment, that is, in patients who have had no prior antidepressant treatments.

• Differences in safety and tolerability between TMS Therapy and AD treatment are important considerations.

  + TMS is non-systemic, so it does not cause side effects such as weight gain, sexual dysfunction, nausea, dry mouth, and sedation, all of which are side effects associated with AD treatment.

  + The most common adverse event related to TMS treatment is scalp pain or discomfort at the treatment area during active TMS treatment. These effects are transient and mild to moderate in severity and the incidence of this side effect declines markedly after the first week of treatment.

• NeuroStar TMS Therapy is the only TMS device that is FDA-cleared, and proven to be safe and effective for the treatment of patients with depression who have failed to achieve satisfactory improvement from prior antidepressant treatment.

• NeuroStar TMS is non-systemic, which means it does not have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, or sedation.

• The most common adverse event related to treatment was scalp pain or discomfort at the treatment area during active treatments, which was transient and mild to moderate in severity. The incidence of this side effect declined markedly after the first week of treatment.

• There is a rare risk of seizure associated with TMS Therapy.

• Not all patients may benefit from NeuroStar TMS Therapy. Like any treatment option, patients and clinicians should work together to find the most appropriate treatment option.

• TMS Therapy has been reimbursed by some insurance plans on a case-by-case basis

• Once in treatment, NeuroStar Care Connection (NCC) can help in the attempt to secure health plan coverage for treatment

• If treatment is reimbursed, there will likely be some out of pocket costs

  • A per treatment co-pay

  • The full cost of TMS will likely not be reimbursed, you will be responsible for the remaining amount

• In mean time, out-of-pocket payment may be required

  • Can be paid from healthcare flexible spending account

  • Patient financing option available through Clark Behavioral Healthcare Financing

• In a health-economic study, NeuroStar TMS Therapy as compared to anti-depressant medication showed favorable value to both patients and health insurance companies

  • It has a favorable benefit/risk ratio compared to alternatives

  • It is associated with less hospitalizations, doctor visits, drugs, etc (data on file).

  • It is one of the only evidence-based treatments for MDD patients who have not adequately benefitted from prior antidepressant medication

  • It provides a significant chance of improvement (1 in 2)

    • Despite not having adequately benefited from previous treatment attempts

  • It has no systemic side effects, such as weight gain and sexual dysfunction

  • It is non-invasive, no anesthesia, no sedation

  • Most common side effects are scalp pain or discomfort and headache

• The most common adverse event related to treatment was scalp pain or discomfort at the treatment area during active TMS treatments, which was transient and mild to moderate in severity. The incidence of this side effect declined markedly after the first week of treatment.

• There is a rare risk of seizure associated with TMS Therapy.

• Less than 5% of patients discontinued the study due to adverse events.

• There is no evidence of these types of magnetic fields causing tumors. TMS Therapy uses the same type and strength of magnetic fields as MRIs, which have been used in tens of millions of patients around the world and have not been shown to cause tumors.

• The amount of magnetic field exposure for a full course of TMS Therapy is a small fraction of just one brain scan with an MRI.

• Longer term effects of exposure to NeuroStar TMS Therapy system’s magnetic fields are not known. Experimental and observational evidence indicates that exposure to the type of magnetic fields produced by the NeuroStar TMS System coil does not present any significant risk of acute or longterm adverse effects.

• NeuroStar TMS Therapy was systematically evaluated for its effects on memory.

• The clinical trials demonstrated that NeuroStar TMS Therapy does not result in adverse effects on memory or concentration

• TMS is an acute therapy.

• With regard to long-term safety, TMS uses the same type and strength of magnetic fields as MRIs, which have been used in tens of millions of patients around the world and have not been shown to have long-term consequences.

• The amount of magnetic field exposure for a full course of TMS Therapy is only a small fraction of one brain scan with an MRI.

• If a patient had multiple courses of acute TMS, the magnetic field exposure would be less than the exposure from a few MRI sessions.

NeuroStar TMS Therapy is indicated for adult patients with major depressive disorder who failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

The important points are:

• NeuroStar TMS Therapy is for patients with MDD who failed to benefit from prior antidepressant medications. It was not studied in patients who have had no prior antidepressant treatment.

• It was only studied in adults (22 years by FDA definition) and was not studied in children (i.e., less than 18 years) or for geriatric use (i.e., older than 70 years)

• “One prior antidepressant medication at minimal effective dose and duration” means a previous antidepressant medication that was given at its minimum labeled dose for at least 4 weeks

• Patients had only ONE exposure that reached this level of adequacy (patients had also had a median of 4 exposures that did not reach this level of adequacy)

• “In the current episode” means that the antidepressant treatments occurred in the current depressive episode.However, if the patient had NO treatment in the current episode, then treatments in the prior episode can be used to determine if there was one adequate antidepressant treatment to which the patient did not benefit

• The Antidepressant Treatment Record supplied by Neuronetics and described in the User Manual can be used by the physician to identify the indicated population.

NeuroStar TMS Therapy is contraindicated (should not be used) in patients who have conductive, ferromagnetic, or other magnetic sensitive metals implanted in their head or are non-removable and within 30 cm of the treatment coil.

Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, and bullet fragments.  Failure to follow this restriction could result in serious injury or death.

The NeuroStar TMS system should be used with caution in the following situations.  All patients must be screened for these conditions and appropriate cautionary measures should be taken.

• Implants controlled by physiological signals

• Implants not controlled by physiological signals within 30 cm of the coil

• Wearable or removable devices or objects that may be affected by the magnetic field

• There is a rare risk of seizure with TMS Therapy.  It should be used with caution in patients with the potential for seizure based on medical or genetic history.

• Depression is a lethal disease and, as with all antidepressants, patients treated with NeuroStar TMS Therapy should be monitored for signs or symptoms of worsening depression.

• The efficacy of NeuroStar TMS Therapy in patients with depression who have failed 2 or more antidepressant treatments has not been proven and it has not been studied in patients who have had no prior antidepressant treatment in the current episode.

• Multiple treatment options are needed to address the significant unmet need in the treatment of depression. Currently, there are few options for patients who have had an inadequate response to previous antidepressant treatments. These patients are often faced with choosing between a complex regimen of multiple drugs or, for more severe cases, more invasive procedures.

• TMS Therapy, is not likely to displace the need for other antidepressant treatment options, but it provides patients with a non-invasive, non-systemic treatment alternative for patients who have failed to benefit from their initial treatment. For these patients, there are very few FDA approved treatment options.

• The safety of NeuroStar TMS Therapy provides a benefit as compared to antidepressant drug classes that carry a significant safety or tolerability burden.

• NeuroStar TMS Therapy was studied as a monotherapy, without  concurrent antidepressants, in the controlled clinical trial and did not study efficacy with additional antidepressants (i.e., as adjunctive therapy).

• NeuroStar TMS Therapy safety during administration with concurrent antidepressant medication was demonstrated in the NeuroStar clinical trials during:

  • The taper phase at the end of two of the acute studies.

  • In the maintenance of effect study, patients who were being treated with antidepressant monotherapy also had periodic reintroductions of TMS Therapy.

• First used in 1985, TMS has been used by researchers around the world to help understand the functions of different parts of the brain. Several hundred manuscripts have been published regarding its use in stimulating select regions of the brain.

• Since the mid 1990s, TMS has been studied as an antidepressant therapy.

• In 2006, the largest randomized, controlled study ever conducted with TMS Therapy was completed. This study was sponsored by Neuronetics and utilized the NeuroStar TMS Therapy system

• The NeuroStar TMS Therapy system was cleared by the U.S. Food and Drug Administration for the treatment of adult patients with major depressive disorder who have failed to receive satisfactory improvement from prior medication antidepressant treatment:

    4 attempts of which 1 was adequate in the current episode

No. There are four main differences between the magnet used in NeuroStar TMS Therapy and the regular magnets used in alternative therapies:

• Regular magnets are typically weak in field strength, while the magnets used in NeuroStar TMS Therapy are much stronger and the same as those used in MRI machines

• Alternative therapy magnets create magnetic fields which do not move in space or time. The magnet used in NeuroStar TMS Therapy is pulsed, which causes the magnetic fields to move rapidly over time. This rapid magnetic field movement is what induces an electric current and then stimulates brain cells.

• No scientific evidence exists to support the therapeutic benefit of regular magnets in the treatment of depression, while rigorous clinical trials have proven the effectiveness of the powerful pulsed magnetic fields used in the NeuroStar TMS Therapy device.

• NeuroStar TMS Therapy is cleared by the FDA, for the treatment of depression while regular magnets are not.

• NeuroStar TMS is the only FDA cleared treatment for depression that uses pulsed magnetic fields.

• NeuroStar TMS Therapy is the first and only TMS device to have been evaluated for safety and effectiveness in a large, multicenter, controlled clinical trial

• NeuroStar is the first and only TMS device to be cleared by the U.S. FDA for the treatment of major depression.

• Any other TMS Device that is claimed to be “FDA-approved” is not cleared for the treatment of depression and has not been shown to be safe and effective for this use.