What is TMS?

NeuroStar Transcranial Magnetic Stimulation (TMS) is a new treatment cleared by the US Food and Drug Administration (FDA) for patients suffering from depression who have not achieved satisfactory improvement from prior antidepressant treatment. TMS is

  • Non-invasive, meaning that it does not involve surgery. It does not require any anesthesia or sedation, as the patient remains awake and alert during the treatment.
  • Non-systemic, meaning that it is not taken by mouth and does not circulate in the blood stream throughout the body.

 

 How does it work?

Through a magnetic coil, the NeuroStar TMS Therapy system generates highly concentrated magnetic fields, which turn on and off very rapidly. These magnetic fields are the same type and strength as those produced by a magnetic resonance imaging (MRI) machine.

The treatment coil is applied to the head above the left prefrontal cortex. This part of the brain is involved with mood regulation, and therefore is the location where the magnetic fields are focused. These magnetic fields do not directly affect the whole brain; they only reach about 2-3 centimeters into the brain directly beneath the treatment coil. As these magnetic fields move into the brain, they produce very small electrical currents. These electrical currents activate cells within the brain, which are thought to release neurotransmitters like serotonin, norepinephrine, and dopamine. Since depression is thought to be the result of an imbalance of these chemicals in the brain, TMS can restore that balance and, thus, relieve depression.

 

How effective is TMS?

Clinical trials have demonstrated the effectiveness of NeuroStar® TMS Therapy in treating patients who have not benefited from prior antidepressant medication. NeuroStar TMS Therapy was studied in adult patients suffering from Major Depressive Disorder, all of whom had not received satisfactory improvement with previous treatments.

In a study where 307 patients received active treatment (similar to a real clinical context), as well as a 12-month follow up, over half of the patients treated with NeuroStar TMS Therapy experienced significant improvement in their depression, anxiety, and physical symptoms. About a third of the patients experienced complete symptom relief at the end of six weeks.

NeuroStar TMS Therapy has not been studied in patients who have not received
prior antidepressant treatment. Its effectiveness has also not been established in patients that have failed to receive benefit from two or more prior antidepressant medications at minimal effective dose and duration in the current episode.

 

What can I expect at my first session?

Because your TMS-certified physician needs to determine how to most effectively administer treatment, your first session could last up to an hour and a half. The physician 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 physician 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 Specialist will then administer TMS Therapy over an approximately 40-minute period. In 30-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 physician may be able to make adjustments to reduce this discomfort.

 

What can I expect after the procedure?

Immediately following each treatment session, you may return to your normal daily routine, including driving.

 

Are there any side effects?

Treatment with NeuroStar TMS Therapy caused very few side effects and was generally well tolerated by patients.

  • No Weight Gain
  • No Sexual Dysfunction
  • No Dry Mouth
  • No Sedation
  • No Nausea
  • No Adverse Effects on Concentration or Memory
  • No Drug Interactions

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.

During or after treatment you may experience 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 physician can temporarily reduce the strength of the magnetic field pulses being administered in order to make treatment more comfortable.

 

How long before I can expect to see results?

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 physician throughout the treatment course. If symptoms persist, you may want to consider other antidepressant options.

 

Is TMS safe?

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

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

 

Will my insurance cover TMS?

It usually takes time for healthcare insurers to establish coverage policies for newly approved treatments such as NeuroStar TMS. Thus, NeuroStar TMS might not be covered currently by your health insurance plan.

If your healthcare provider does not cover NeuroStar TMS, you can work with your provider and the NeuroStar Reimbursement Support program to seek case-by-case reimbursement for your treatment. More information about the NeuroStar Reimbursement Support Program can be found at: http://neurostar.com/neurostar-health-insurance-coverage/

 

Where can I learn more about TMS?

Answers to other questions can be found here.