FAQ

• No side effects such as weight gain, sexual problems, stomach problems, sleepiness, or dry mouth were seen during trials
• There were no negative effects on memory or ability to concentrate

The most commonly reported side effect related to treatment was scalp pain or discomfort during the treatment session. This side effect was generally mild to moderate, and occurred less frequently after the first week of treatment. Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment due to side effects.

NeuroStar TMS Therapy has been demonstrated to be effective in Major Depressive Disorder. Efficacy was established in a controlled clinical trial comparing active treatment with the NeuroStar TMS Therapy system to an inactive device. Patients treated with active NeuroStar TMS Therapy experienced an average reduction in their depression symptom score of 22.1% compared to a 9% average reduction in patients receiving inactive treatment. NeuroStar-treated patients also experienced significant improvement in anxiety, appetite changes, aches and pains, and lack of energy associated with depression.

In an open label trial, which is most like a real world clinical practice, approximately 1 out of 2 patients treated with NeuroStar TMS Therapy experienced significant improvement in depression symptoms. Approximately 1 out of 3 patients treated with NeuroStar TMS Therapy experienced complete symptom relief at the end of 6 weeks. As with any antidepressant treatment, patients should be monitored for symptoms of worsening depression.

NeuroStar TMS Therapy is an appropriate treatment option for adult patients with Major Depressive Disorder who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. In clinical trials, half of the patients had been treated with at least four medication treatment attempts, one of which was at an adequate dose and duration.

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

Not all patients are appropriate candidates for NeuroStar TMS Therapy. To determine if NeuroStar TMS Therapy may be right for you, contact our office for an assessment.

TMS should not be used in people with metal implants or non-moveable metal objects in or around the head. If you have a metal plate or an aneurysm coil, this could result in serious brain injury.

Patients with braces and/or metal fillings are acceptable for treatments. Any other metal within your mouth (tongue piercings, etc.) should be discussed with the TMS Coordinator.

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).

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 a 10% relapse rate at the end of six months.
• Half of the patients experienced symptom breakthrough and required re-treatment with TMS.

TMS is considered 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 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 exposure from a few MRI sessions.

No. There is a significant gap in the treatment of depression when patients do not respond to medication treatments. Currently there are few options for patients who have had an inadequate response to previous antidepressant treatments. They may be placed on a complex regimen of multiple medications that could have an impact on other medical conditions or choose to be treated with more serious and invasive procedures. While TMS therapy is a new treatment option, it does not displace the need for other antidepressants.

NeuroStar TMS therapy has an excellent safety profile. Depending on the person’s prior medication response or other medical conditions, TMS may be used earlier in the treatment than some antidepressant drug classes that may pose safety or tolerability risks.

NeuroStar TMS Therapy was studied in depressed patients who had failed to receive benefit from prior antidepressant medications. A 6-week, randomized, placebo-controlled, double-blind, study was conducted to evaluate the safe and effective use of NeuroStar TMS as a monotherapy.

An analysis for predictors of response demonstrated that the patients with the best response to NeuroStar TMS Therapy were adults who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. They had received a median of 4 total prior antidepressant treatment attempts in the current episode, one of which achieved treatment adequacy at or above the minimal effective dose and duration.

In these patients, the following efficacy results were observed in the randomized, controlled study:

• The primary efficacy measure was statistically superior to placebo (p=0.0006) among NeuroStar treated patients.
• NeuroStar TMS therapy-treated patients had statistically significant response and remission rates which were approximately twice the rate of placebo-treated patients.

Patients who did not respond in the randomized, controlled study entered into a 6-week, open-label treatment study. In the open-label study, which is most like real-world clinical practice, the following was observed:

• Patients treated for the first time with NeuroStar TMS therapy achieved a 54% response rate and a 33% remission rate on the HAM-D 25 item scale at the end of six weeks of treatment.
• Similar results were observed using the MADRS rating scale.

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

• No systemic side effects, such as weight gain, sexual dysfunction, sedation, nausea, or dry mouth.
• The most common side effect reported related to TMS treatment was scalp discomfort during the treatment session.
• There was a less than 5% discontinuation rate due to adverse events.

NeuroStar has only systematically been evaluated in patients with unipolar, non-psychotic major depression. While there is promising data in a variety of other disorders, these data are preliminary and require systematic evaluation in controlled clinical trials.

Clinical trials are underway for expanded use of TMS. You can find out more about the TMS clinical trials for a variety of disorders on http//:clinicaltrials.gov. These are closely controlled, scientific research studies involving patients and volunteers. Once the trials are completed, detailed analysis of the data will result in published findings about the efficacy of the TMS treatment for the disorder being studied.

ECT and TMS both used applied energy to the brain to cause neural stimulation for relieving the symptoms of depression. ECT uses electrical energy applied to the whole brain, while TMS uses magnetic energy applied only to the left prefrontal cortex.

ECT is an effective acute treatment for major depression, but is highly invasive (causing seizure induction and requiring anesthesia) and has significant adverse effects. In contrast, TMS is also effective in patients with Major Depressive Disorder but is non-invasive and has an excellent safety profile.

TMS will likely be used much earlier in the treatment algorithm, because of its favorable risk/benefit ratio. ECT will always have an important role for certain depression patients despite safety concerns; however, will be reserved as a “last resort”.

NeuroStar TMS therapy is an outpatient procedure. Unlike electroconvulsive therapy, TMS does not require anesthesia, sedation and the production of a convulsion. Also different from ECT, NeuroStar TMS therapy does not result in adverse effects on memory or concentration. Because of these issues, ECT is often reserved as a last resort.

TMS will likely be used much earlier in the treatment choice algorithm, because of its favorable risk/benefit to the patient.

Insurance coverage varies based on the payer and is handled on a case by case basis. While many insurances have not initially covered this treatment, some have recently provided approval. We are currently working with a third party agency that will contact your insurance company and advocate of your behalf in attempt to get either partial or full coverage.

If you do not have insurance coverage, we will provide assistance with how payment can be managed.

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