Frequently Asked Questions
Simply click on any question below to expand and read the answer.
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 a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation, which 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 40-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist’s office.
The treatment is typically administered daily for 4-6 weeks.
TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation, which 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 40-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist’s office.
The treatment is typically administered daily for 4-6 weeks.
What happens during TMS Therapy? What’s the mechanism of action?
During NeuroStar TMS Therapy, pulsed magnetic fields are repetitively transmitted into the left prefrontal cortex, the part of the brain that is thought to regulate mood, in order to stimulate the firing of neurons (nerve cells).
This is believed to trigger a cascade of neurochemical events, including the release of neurotransmitters (such as serotonin, norepinephrine, and dopamine) and to help normalize neurotransmitter function.
This is believed to trigger a cascade of neurochemical events, including the release of neurotransmitters (such as serotonin, norepinephrine, and dopamine) and to help normalize neurotransmitter function.
How long does a patient undergo TMS therapy?
In clinical trials, patients received NeuroStar TMS Therapy 5 times per week for approximately 40 minutes during each session for 4-6 weeks.
What are the benefits of TMS?
NeuroStar TMS Therapy is the first and only non-systemic and non-invasive depression treatment to be cleared by the FDA.
It is indicated for adult patients who did not achieve satisfactory improvement from prior antidepressant medication
- Median of 4 treatment attempts, 1 of which was adequate
In clinical trials, 1 in 2 patients had significant improvement in symptoms and 1 in 3 had complete symptom resolution
Since it’s non-systemic, it doesn't have side effects such as weight gain, sexual dysfunction, nausea, sedation, dry mouth, etc.
- Median of 4 treatment attempts, 1 of which was adequate
In clinical trials, 1 in 2 patients had significant improvement in symptoms and 1 in 3 had complete symptom resolution
Since it’s non-systemic, it doesn't have side effects such as weight gain, sexual dysfunction, nausea, sedation, dry mouth, etc.
How long does the antidepressant effect last? Do patients need to go back for another session?
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 10% relapse rate at the end of 6 months
~ Half of patients experienced symptom breakthrough and required TMS Therapy re-treatment
Patients previously treated with NeuroStar TMS Therapy had less than 10% relapse rate at the end of 6 months
~ Half of patients experienced symptom breakthrough and required TMS Therapy re-treatment
Is TMS therapy a good alternative for patients who are fearful of the side effects associated with antidepressant medications?
NeuroStar TMS Therapy has been cleared by U.S. FDA for the treatment of patients with depression who have failed to achieve satisfactory improvement from prior antidepressant treatment. NeuroStar is non-systemic, so it doesn’t have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc. Like any treatment option, patients and clinicians should work together to find the most appropriate treatment option for each patient.
Does NeuroStar TMS hurt?
The most common adverse event related to treatment was scalp pain or discomfort at the treatment area during active treatments, which was transient and mild to moderate in severity. The incidence of this side effect declined markedly after the first week of treatment.
Less than 5% of patients discontinued the study due to adverse events.
Does NeuroStar TMS cause brain tumors?
No, TMS Therapy 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 tumors. The amount of magnetic field exposure for a full course of TMS Therapy is a small fraction of just one brain scan with an MRI.
What are the long-term consequences of TMS treatment?
TMS is 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
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
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 is for patients with MDD only who failed to benefit from prior antidepressant medications
It 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.
Patients had only ONE exposure that reached this level of adequacy (patients had also had a median of 4 exposures that did not reach this level of adequacy)
"In the current episode" means all of this applies only to the current depressive episode, however, if the patient had NO treatment in the current episode, then one can look back to the prior episode to see if there was one adequate treatment to which the patient did not benefit.
NeuroStar TMS Therapy is for patients with MDD only who failed to benefit from prior antidepressant medications
It 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.
Patients had only ONE exposure that reached this level of adequacy (patients had also had a median of 4 exposures that did not reach this level of adequacy)
"In the current episode" means all of this applies only to the current depressive episode, however, if the patient had NO treatment in the current episode, then one can look back to the prior episode to see if there was one adequate treatment to which the patient did not benefit.
Why does it not work/not FDA-cleared in patients who failed to benefit from more than one antidepressant medication? Isn’t that where the need is? Why such a narrow indication?
The NeuroStar studies did not include enough patients who failed more than 1 prior adequate medication to determine if NeuroStar is effective in these patients.
Therefore, one can only conclude that efficacy has not been established in these patients.
NeuroStar was safely administered to these patients.
Therefore, one can only conclude that efficacy has not been established in these patients.
NeuroStar was safely administered to these patients.
What are the risks of TMS therapy?
NeuroStar TMS Therapy is contraindicated (should not be used) in patients with implanted metallic devices or non-removable metallic objects in or around the head. It also should not be used in patients with implanted devices that are controlled by physiological signals such as pacemakers, etc…
Are there other patients for whom NeuroStar TMS Therapy could pose a risk?
Depression is a lethal disease and, as with all antidepressants, patients treated with NeuroStar TMS Therapy should be monitored for signs or symptoms of worsening depression. The efficacy of NeuroStar TMS Therapy in patients with depression who have failed 2 or more antidepressants has not been proven and it has not been studied in patients who have had no prior antidepressant treatment in the current episode.
Is TMS therapy a good alternative for patients who are fearful of the side effects associated with antidepressant medications?
NeuroStar TMS Therapy has been cleared by U.S. FDA for the treatment of patients with depression who have failed to achieve satisfactory improvement from prior antidepressant treatment. NeuroStar is non-systemic, so it doesn’t have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc. Like any treatment option, patients and clinicians should work together to find the most appropriate treatment option for each patient.
How effective is TMS therapy compared with drugs?
NeuroStar was not compared in head-to-head studies with antidepressant medications.
It is difficult to compare NeuroStar vs. drugs, because they have been studied in different patient populations
· The patients for which NeuroStar has been FDA-cleared had failed multiple treatment attempts, one of which achieved an adequate dose and duration
· Almost all antidepressant medications have been studied and approved for 1st-line treatment.
In the NeuroStar randomized controlled trial, almost 3x the number of NeuroStar-treated patients had a significant improvement in symptoms compared to placebo.
Finally, it’s also important to consider safety and tolerability.
· TMS is non-systemic, so it doesn’t cause side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc.
It is difficult to compare NeuroStar vs. drugs, because they have been studied in different patient populations
· The patients for which NeuroStar has been FDA-cleared had failed multiple treatment attempts, one of which achieved an adequate dose and duration
· Almost all antidepressant medications have been studied and approved for 1st-line treatment.
In the NeuroStar randomized controlled trial, almost 3x the number of NeuroStar-treated patients had a significant improvement in symptoms compared to placebo.
Finally, it’s also important to consider safety and tolerability.
· TMS is non-systemic, so it doesn’t cause side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc.
Is TMS Therapy intended to replace antidepressant medications?
No, there is a 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. They are often faced with choosing between a complex regimen of multiple drugs or, for more severe cases, more invasive procedures.
While TMS Therapy is a new treatment option, we do not believe it will displace the need for other antidepressants.
Based on its excellent safety profile, NeuroStar TMS Therapy may be used earlier in the treatment algorithm than antidepressant drug classes that carry a significant safety/tolerability burden.
Can TMS patients also take an antidepressant(s)?
NeuroStar TMS Therapy was studied as a monotherapy without additional antidepressants in the controlled clinical trial so the efficacy with additional antidepressants (i.e., as adjunctive therapy) is not known.
NeuroStar TMS Therapy was safety administered in conjunction with medication antidepressants and this replicated what has been shown in the many literature-based single center trials of TMS
In clinical trials, patients were administered antidepressant medications 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 and also had periodic reintroductions of TMS Therapy.
NeuroStar TMS Therapy was safety administered in conjunction with medication antidepressants and this replicated what has been shown in the many literature-based single center trials of TMS
In clinical trials, patients were administered antidepressant medications 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 and also had periodic reintroductions of TMS Therapy.