TMS - FAQ
For more information about TMS, review the following sources:
- EVMS video on TMS
- TMS Grand Rounds presentation on Feb. 9, 2011 by Dr. Janicak
- NIMH study
- Neurostar TMS Patient Video
What is NeuroStar TMS Therapy?
- The NeuroStar TMS Therapy system is the first and only TMS Therapy® device cleared by the FDA for the treatment of depression.
- TMS Therapy is non-invasive (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.
- Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert.
- It is a 37-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist's office.
- The treatment is typically administered 5 times per week for 4-6 weeks. Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgment.
How long does the antidepressant effect of NeuroStar TMS Therapy last? Do patients need to go back for another treatment session?
During the six-month maintenance of effect study with NeuroStar TMS Therapy,
- For patients previously treated with NeuroStar TMS Therapy, less than 10% relapsed at the end of 6 months.
- Approximately half of the patients experienced symptom breakthrough and required TMS Therapy re-treatment.
What is the FDA-cleared indication and what does it mean?
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 (i.e., less than 18 years) or for geriatric use (i.e., 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.
How does NeuroStar TMS Therapy compare to antidepressant drugs (AD) as a depression treatment?
- Comparison of NeuroStar TMS and AD medication efficacy can be done using statistical methods that permit valid cross-study comparisons. These methods show that NeuroStar TMS Therapy efficacy compares favorably with that of current antidepressant medication treatment options; however, NeuroStar TMS has not been compared in head-to-head studies with antidepressant medications.
- Trials to compare NeuroStar TMS vs. drugs have not been performed because these treatments are directed towards patient populations that differ in their level of "treatment resistance", which means how many times they received antidepressant medication and did not receive benefit.
- The patients for which NeuroStar has been FDA-cleared had failed multiple antidepressant treatment attempts, one of which achieved an adequate dose and duration
- Almost all antidepressant medications have been studied for 1st-line treatment, that is, in patients who have had no prior antidepressant treatments.
- Differences in safety and tolerability between TMS Therapy and AD treatment are important considerations.
- TMS is non-systemic, so it does not cause side effects such as weight gain, sexual dysfunction, nausea, dry mouth, and sedation, all of which are side effects associated with AD treatment.
- The most common adverse event related to TMS treatment is scalp pain or discomfort at the treatment area during active TMS treatment. These effects are transient and mild to moderate in severity and the incidence of this side effect declines markedly after the first week of treatment.
Is NeuroStar TMS Therapy intended to replace antidepressant medications?
TMS Therapy is not likely to displace the need for other antidepressant treatment options. Multiple treatment options are needed to address the significant unmet need in the treatment of depression. Currently, there are few options for patients who have had an inadequate response to previous antidepressant treatments. These patients are often faced with choosing between a complex regimen of multiple drugs or, for more severe cases, more invasive procedures.
Can patients treated with NeuroStar TMS Therapy also take an antidepressant(s)?
NeuroStar TMS Therapy safety 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.
If patients have to go back on antidepressant drug use after TMS treatment, then why even use TMS?
- 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.
What is the history of TMS Therapy?
- 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 utilized the NeuroStar TMS Therapy system.
- The NeuroStar TMS Therapy system was cleared by the U.S. Food and Drug Administration for the treatment of adult patients with major depressive disorder who have failed to receive satisfactory improvement from prior medication antidepressant treatment
- 4 attempts of which 1 was adequate in the current episode.
Will NeuroStar TMS Therapy be covered by insurance and/or Medicare?
- 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.
How does NeuroStar TMS Therapy compare to ECT? Is TMS a replacement for ECT?
- 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 non-invasive.
- 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, and has an excellent safety and tolerability profile.
How the NeuroStar clinical trials designed and what were the results of the trials?
- NeuroStar TMS Therapy was studies in 301 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.
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 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 HAMD 24-item scale at the end of 6 weeks
- Similar results were observed using the MADRS rating scale.
Are the rates of response and remission clinically meaningful to patients?
- 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 3x 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, ~1 in 2 patients had a significant improvement and 1 in 3 had complete symptom resolution.
What were the patient selection criteria for the NeuroStar study?
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.
Is there data available on suicide and/or violent behavior rates during treatment in the NeuroStar clinical trials?
- 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.