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NeuroStar Safety

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

 

Treatment with NeuroStar TMS 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 TMS Therapy due to adverse events.

 

Over 10,000 active treatments were performed across all NeuroStar® clinical trials demonstrating its safety1

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

 

TMS Therapy Treatments

 

Procedure

 

A NeuroStar® TMS Therapy 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 provider 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 provider 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 provider 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 technician will then administer TMS Therapy 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 TMS team 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 technician 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 TMS Therapy 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 TMS team 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. Our staff will check your TMS benefits for you and review the details with you prior to treatment.

References:

  1. Janicak, P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal of Clinical Psychiatry, February 2008.

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