FAQ About TMS

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ABOUT NEUROSTAR TMS THERAPY

What is NeuroStar 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 40-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist’s office.
  • The treatment is typically administered five times weekly for four to six weeks.

What happens during TMS Therapy? What’s the mechanism of action?

  • 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.

How long does a patient undergo TMS therapy?

In clinical trials, patients received NeuroStar TMS Therapy five times per week for approximately 40 minutes during each session for four to six weeks. Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgment.

What are the benefits of TMS?

  • NeuroStar TMS Therapy is the first and only non-systemic and non-invasive depression treatment to be cleared by the FDA.
  • It is indicated for adult patients who did not achieve satisfactory improvement from prior antidepressant medication.
  • In clinical trials, one in two patients had significant improvement in symptoms, and one in three had complete symptom resolution.
  •  Since TMS is non-systemic, it doesn’t have side effects such as weight gain, sexual dysfunction, nausea, sedation, dry mouth, etc.

How long does the antidepressant effect last? Do patients need to go back for another session?

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:

  • Patients previously treated with NeuroStar TMS Therapy had less than 10% relapse rate at the end of six months.
  • Half of patients experienced symptom breakthrough and required TMS Therapy re-treatment.

Is TMS therapy a good alternative for patients who are fearful of the side effects associated with antidepressant medications?

  • NeuroStar TMS Therapy has been cleared by the U.S. FDA for the treatment of patients with depression who have failed to achieve satisfactory improvement from prior antidepressant treatment.
  • NeuroStar is non-systemic, so it doesn’t have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc.
  • Like any treatment option, patients and clinicians should work together to find the most appropriate treatment option for each patient.

Does NeuroStar TMS hurt?

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

Does NeuroStar TMS cause brain tumors?

  • No, 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.

What are the long-term consequences of TMS treatment?

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

What is the FDA-cleared indication and what does it mean?

  • 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 only who failed to benefit from prior antidepressant medications.
    • 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 four weeks.
    • Patients had only one exposure that reached this level of adequacy. (Patients had also had a median of four exposures that did not reach this level of adequacy.)
    • “In the current episode” means all of this applies only to the current depressive episode, however, if the patient had no treatment in the current episode, then one can look back to the prior episode to see if there was one adequate 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.

Why does it not work/not FDA-cleared in patients who failed to benefit from more than one antidepressant medication? Isn’t that where the need is? Why such a narrow indication?

  • The NeuroStar studies did not include enough patients who failed more than one prior adequate medication to determine if NeuroStar is effective in these patients.
  • Therefore, one can only conclude that efficacy has not been established in these patients. NeuroStar was safely administered to these patients.

What are the risks of TMS therapy?

NeuroStar TMS Therapy is contraindicated (should not be used) in patients with implanted metallic devices or non-removable metallic objects in or around the head. It also should not be used in patients with implanted devices that are controlled by physiological signals such as pacemakers, etc.

Are there other patients for whom NeuroStar TMS Therapy could pose a risk?

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 two or more antidepressants has not been proven and it has not been studied in patients who have had no prior antidepressant treatment in the current episode.

How effective is TMS therapy compared with drugs?

  • NeuroStar was not compared in head-to-head studies with antidepressant medications.
  • It is difficult to compare NeuroStar vs. drugs, because they have been studied in different patient populations.
    • The patients for whom NeuroStar has been FDA-cleared had failed multiple treatment attempts, one of which achieved an adequate dose and duration.
    •  Almost all antidepressant medications have been studied and approved for first-line treatment.
    • In the NeuroStar randomized controlled trial, almost three times the number of NeuroStar-treated patients had a significant improvement in symptoms compared to placebo.
    • Finally, it’s also important to consider safety and tolerability.
      • TMS is non-systemic, so it doesn’t cause side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc.

Is TMS Therapy intended to replace antidepressant medications?

  • No, there is a 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. They are often faced with choosing between a complex regimen of multiple drugs or, for more severe cases, more invasive procedures.
  • While TMS Therapy is a new treatment option, we do not believe it will displace the need for other antidepressants.
  • Based on its excellent safety profile, NeuroStar TMS Therapy may be used earlier in the treatment algorithm than antidepressant drug classes that carry a significant safety/tolerability burden.

Can TMS patients also take an antidepressant(s)?

  • NeuroStar TMS Therapy was studied as a monotherapy without additional antidepressants in the controlled clinical trial, so the efficacy with additional antidepressants (i.e., as adjunctive therapy) is not known.
  • NeuroStar TMS Therapy was safely administered in conjunction with medication antidepressants, and this replicated what has been shown in the many literature-based single center trials of TMS.
  • In clinical trials, patients were administered antidepressant medications 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 and also had periodic reintroductions of TMS Therapy.

If patients have to go back on drugs anyway, then what’s the point?

  • NeuroStar is used for the acute treatment of patients with depression who have not received satisfactory improvement from prior antidepressant treatment.
  • Most patients who benefited from TMS were able to retain effect for up to six months on only one antidepressant medication at a minimal dose.
  • These patients had failed a median of four antidepressant treatment attempts, one adequate treatment.
  • In the open-label trial, which is most like the real world, among NeuroStar-treated patients, one in two achieved a significant improvement in symptoms and one in three had complete symptom resolution.
  • Since NeuroStar is non-systemic, these results were achieved without side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc.

What is the history of TMS Therapy?

  • First used in 1985, TMS has been used by researchers around the world to help understand the function 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.
  • Recently, 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, four attempts of which one was adequate in the current episode.

Will treatment be covered by insurance and/or Medicare?

  • Over 130 million patients have insurance policies that cover NeuroStar TMS Therapy through their health plans.
  • TMS Therapy has been reimbursed by some inruance plans on a case-by-case basis. However, the process for unique, new procedures like this to be reimbursed by most insurance plans usually takes on to two years.
  • We believe there are compelling reasons for it to be reimbursed:
    • Target patients have few proven and tolerable options
    • Rigorously-designed clinical studies
    • Benefit-risk ratio compares favorably to alternatives
    • Compelling health economics for payers

Is TMS Therapy like the magnetic bracelets?

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

Are there other treatments for depression that rely on magnetic fields?

  • No.

Does NeuroStar cause memory loss?

  • 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.

Does clearance of NeuroStar TMS Therapy mean that all TMS devices are cleared for use in major depression within the United States?

  • No. NeuroStar TMS Therapy is the first and only TMS device to have been evaluated 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.