Frequently Asked Questions

  • 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 5 days per week 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 approximately 40 minutes during each session for 4-6 weeks.
  • Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgment.

  • It is indicated for adult patients who did not achieve satisfactory improvement from prior antidepressant medication.
  • In clinical trials, 1 in 2 patients had significant improvement in symptoms and 1 in 3 had complete symptom resolution.
  • NeuroStar is non-systemic, so it doesn’t have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc .

  • Patients treated with NeuroStar TMS Therapy had less than 10% relapse rate at the end of 6 months.
  • Half of patients experienced symptom breakthrough and required TMS Therapy re-treatment.

  • Like any treatment option, patients and clinicians should work together to find the most appropriate treatment option for each patient.

  • 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.

  • 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.

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

  • The NeuroStar studies did not include enough patients who failed more than 1 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.

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.

Depression is a 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 antidepressants has not been proven and it has not been studied in patients who have had no prior antidepressant treatment in the current episode.

  • 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 which 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 1st-line treatment.
  • In the NeuroStar randomized controlled trial, almost 3x the number of NeuroStar-treated patients had a significant improvement in symptoms compared to placebo.
  • 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.

  • 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.

  • 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 safety 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 also had periodic reintroductions of TMS Therapy.

  • 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 6 months on only one antidepressant medication at a minimal dose.
  • These patients had failed a median of 4 antidepressant treatment attempts, one adequate treatment.
  • In the open-label trial, which is most like the real world, among NeuroStar-treated patients, 1 in 2 achieved a significant improvement in symptoms and 1 in 3 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.

  • 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

  • We certainly hope, and expect, that it will.
  • However, the process for unique, new procedures like this to be reimbursed usually takes 1-2 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

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

  1. 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.
  2. 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.
  3. 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.
  4. NeuroStar TMS Therapy is cleared by the FDA, while regular magnets are not.

No.

  • 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.

  • 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.