TMS - Risks and Benefits

Benefits of TMS

What are the benefits of NeuroStar TMS Therapy?

  • 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 
  • 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

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

  • 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.

 

Risks of TMS

What are the risks of NeuroStar TMS therapy?

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

Commonly reported side effects include:

  • Scalp discomfort 
  • Headache 
  • Neck Pain

Combination of TMS with bupropion (Wellbutrin) has been reported to cause tinnitus, or ringing in the ears. Other medications may increase the risk of seizure including, antipsychotic medications and tricyclic antidepressants. Please notify your physician if you are taking one of these medications, as your dosage may need to be adjusted prior to TMS treatment.

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

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.

Does NeuroStar TMS cause brain tumors?

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.

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

What side effects did patients participating in the clinical trials experience during NeuroStar TMS Therapy?

Throughout the clinical studies, more than 10,000 active TMS treatments demonstrated the safety of NeuroStar TMS Therapy. The following were the safety results observed:

  • There were no systemic side effects, such as weight gain, sexual dysfunction, sedation, nausea, or dry mouth. 
  • 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. 
  • Less than 5% of patients discontinued the study due to adverse events.
  • There is a rare risk of seizure associated with TMS Therapy; however, no seizures were reported during the study.

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 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.
  • 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 long-term adverse effects.