FAQs

The NeuroStar TMS Therapy system is the first TMS Therapy device cleared by the FDA for the treatment of depression. TMS Therapy is noninvasive (does not involve surgery) and stimulates nerve cells in an area of the brain that is linked to depression by delivering highly-focused MRI-strength magnetic pulses.  

NeuroStar TMS Therapy is a 37-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist's office. Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert. The treatment is typically administered five times per week for four to six weeks. Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgment.

During the six-month maintenance of effect study with NeuroStar TMS Therapy:

• Less than 10% of patients who were previously treated with NeuroStar TMS Therapy relapsed at the end of six months. 
• Approximately half of the patients experienced symptom breakthrough and required TMS Therapy retreatment.

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 was only studied in adults (22 years by FDA definition) and was not studied in children (less than 18 years) or for geriatric use (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. 
• "In the current episode" means that the antidepressant treatments occurred in the current depressive episode. However, if the patient had no treatment in the current episode, then treatments in the prior episode can be used to determine if there was one adequate antidepressant treatment to which the patient did not benefit.

The safety of NeuroStar TMS Therapy during administration with concurrent antidepressant medication was demonstrated in the NeuroStar clinical trials 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.

In the NeuroStar clinical studies, patients who had completed a full course of TMS treatments were transitioned to one antidepressant medication in order to minimize the return of symptoms and were able to maintain their symptom improvement achieved with NeuroStar TMS therapy. 

Psychiatrists should use their clinical judgment to determine whether or not antidepressant medications should be prescribed or resumed after acute TMS therapy is completed as based on the individual patient psychiatric and medication history.

First used in 1985, TMS has been used by researchers around the world to help understand the functions 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 used the NeuroStar TMS Therapy system. 

The NeuroStar TMS Therapy system was cleared by the U.S. Food and Drug Administration in 2008 for the treatment of adult patients with major depressive disorder who have failed to receive satisfactory improvement from prior medication antidepressant treatment.

Initial evaluations for TMS treatment are covered by insurance companies.

Not all insurers cover TMS. As such, patients are responsible for all costs incurred with this service upfront. Patients may consider using a healthcare flexible spending account or a financing option through a bank or other lender.

It is recommended that patients work directly with their insurance companies to determine coverage and inquire about assistance for reimbursement of out-of-pocket expenses. EVMS and Neuronetics, the manufacturer of the TMS equipment, can assist patients with this process through the Neurostar Care Connection program.

ECT is an effective acute treatment for major depression, but it 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 noninvasive.

ECT and TMS use applied energy to the brain to cause neural stimulation to relieve depression symptoms. ECT uses electrical energy applied to the whole brain and is usually reserved as a treatment of "last resort," while TMS uses magnetic energy applied only to a specific area.

Unlike ECT, TMS:

• Does not require anesthesia, sedation and the production of a convulsion
• Does not result in adverse effects on memory or concentration
• Has an excellent safety and tolerability profile

NeuroStar TMS Therapy was studied in 301 depressed patients who had failed to receive benefit from prior antidepressant medications.  A six-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.

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

• The primary efficacy measure was statistically significantly 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 six-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 HAMD 24-item scale at the end of six weeks.
• Similar results were observed using the MADRS rating scale.

Yes, particularly in patients who had failed multiple treatment attempts, one of which achieved an adequate dose and duration. 

In the randomized, controlled trial, almost three times the number of NeuroStar-treated patients had a significant improvement in symptoms as compared to placebo. In the NeuroStar open-label trial (which is most like the real world) about one in two patients had a significant improvement and one in three had complete symptom resolution.

• Adults
• Unipolar
• Non-psychotic depression diagnosis
• Failed at least one, but no more than four previous medications at an adequate dose and duration in the current episode

There were no incidents of reported suicide or suicide attempts in patients treated with NeuroStar TMS Therapy during the clinical trials. Patients who were at high risk of suicide were not included in the trial. In addition, there was no evidence that NeuroStar TMS Therapy was associated with worsening of suicidal ideation during acute treatment.