- What is NeuroStar TMS treatment?
- What happens during NeuroStar TMS treatment?
- How long does a patient undergo NeuroStar TMS treatment?
- What are the benefits of NeuroStar TMS treatment?
- How long does the antidepressant effect of NeuroStar TMS treatment last?
- Is NeuroStar TMS treatment a good alternative for patients who are fearful of the side effects associated with antidepressant medications?
- Does NeuroStar TMS cause brain tumors?
- What is the FDA-cleared indication and what does it mean?
- What are the risks of NeuroStar TMS treatment?
- Is NeuroStar TMS treatment intended to replace antidepressant medications?
- If patients have to go back on antidepressant drug use after TMS treatment, then why even use TMS?
- What is the history of TMS treatment?
- Will NeuroStar TMS treatment be covered by insurance and/or Medicare?
- Is NeuroStar TMS treatment like the magnetic bracelets?
- Does NeuroStar cause memory loss?
- What were the safety results from the clinical trials?
- Is there data available on suicide and/or violent behavior rates during treatment in the NeuroStar clinical trials?
- Is NeuroStar TMS treatment effective in treating other disorders?
- How is NeuroStar TMS treatment different from Cyberonics' VNS treatment?
- How does NeuroStar TMS treatment compare to ECT? Is TMS a replacement for ECT?
- Is NeuroStar TMS treatment less effective than ECT?
What is NeuroStar TMS treatment?
The NeuroStar TMS treatment systems in the first and only TMS treatment device cleared by the FDA for the treatment of depression.
TMS treatment 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 treatment do not require anesthesia or sedation and remain awake and alert.
It is typically a 37-minute procedure that is prescribed by a psychiatrist and performed in a psychiatrist's office as an outpatient.
The treatment is typically administered daily for 4-6 weeks.
What happens during NeuroStar TMS treatment?
During NeuroStar TMS treatment, 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.
How long does a patient undergo NeuroStar TMS treatment?
In clinical trials, patients received NeuroStar TMS treatment 5 times per week for 37 minutes each session for 4-6 weeks.
Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgement.
What are the benefits of NeuroStar TMS treatment?
NeuroStar TMS treatment is the first and only non-systemic and non-invasive depression treatment to be cleared by the FDA for the treatment of depression.
It is indicated for adult patients who did not achieve satisfactory improvement from prior antidepressant medication in the current depressive episode. A median of 4 treatment attempts, 1 of which was adequate in dose and duration.
In clinical trials, 1 in 2 patients had significant improvement in symptoms and 1 in 3 had complete symptoms resolution.
It is non-systemic, which means it does not have side effects such as weight gain, sexual dysfunction, nausea, sedation, or dry mouth.
How long does the antidepressant effect of NeuroStar TMS treatment last?
During the six-month maintenance of effect study with NeuroStar TMS treatment, patients were maintained on antidepressant mono treatment and received periodic NeuroStar TMS treatment for symptom worsening. During this study:
- For patients previously treated with NeuroStar TMS treatment, less than 10% relapsed at the end of 6 months.
- Approximately half of the patients experienced symptom breakthrough and required TMS treatment re-treatment.
Is NeuroStar TMS treatment a good alternative for patients who are fearful of the side effects associated with antidepressant medications?
NeuroStar TMS treatment is the only TMS device that is FDA-cleared, and proven to be safe and effective for the treatment of patients with depression who have failed to achieve satisfactory improvement from prior antidepressant treatment.
NeuroStar TMS is non-systemic, which means it does not have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, or sedation.
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 the side effect declined markedly after the first week of treatment.
There is a rare risk of seizure associated with TMS treatment.
Not all patients may benefit from NeuroStar TMS treatment. Like any treatment option, patients and clinicians should work together to find the most appropriate treatment option.
Does NeuroStar TMS cause brain tumors?
There is no evidence of these types of magnetic fields causing tumors. TMS treatment uses the same type and strength of magnetic fields as MRIs, which have been used in tens of millions of patients are the world and have not been shown to cause tumors.
The amount of the magnetic field exposure for a full course of TMS treatment is a small fraction of just one brain scan with an MRI.
Longer term effects of exposure to NeuroStar TMS treatment system's magnetic fields are not known. Experimental and observational evidence indicates that exposure to the type of magnetic fields produced by the NeuroStar TMS System coil does not present any significant risk of acute or long term adverse events.
What is the FDA-cleared indication and what does it mean?
NeuroStar TMS treatment 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 treatment is for patients with MDD who failed to benefit from prior antidepressant medications. It was not studied in patients who have had no prior antidepressant treatment.
- 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 only had 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 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 Antidepressant treatment Record supplied by Neuronetics and described in the User Manual can be used by the physician to identify the indicated population.
What are the risks of NeuroStar TMS treatment?
NeuroStar TMS treatment is contraindicated (should not be used) in patients who have conductive, ferromagnetic, or other magnetic sensitive metals implanted in their head or are non-removable and within 30 cm of the treatment coil. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, and bullet fragments. Failure to follow this restriction could results in serious injury or death. The NeuroStar TMS system should be used with caution in the following situations. All patients must be screened for these conditions and appropriate cautionary measures should be taken.
- Implants controlled by physiological signals.
- Implants not controlled by physiological signals within 30 cm of the coil.
- Wearable or removable devices or objects that may be affected by the magnetic field.
Is NeuroStar TMS treatment intended to replace antidepressant medications?
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.
TMS treatment, is not likely to displace the need for other antidepressant treatment options, but it provides patients with a non-invasive, non-systemic treatment alternative for patients who have failed to benefit from their initial treatment. For these patients, there are very few FDA approved treatment options.
The safety of NeuroStar TMS treatment provides a benefit as compared to antidepressant drug classes that carry a significant safety or tolerability burden.
If patients have to go back on antidepressant drug use after TMS treatment, then why even use TMS?
NeuroStar TMS treatment is used for the acute treatment of patients with depression who have not received satisfactory improvement from prior antidepressant treatment.
The NeuroStar clinical studies included patients who did not receive adequate treatment for one or more concurrent antidepressant medication.
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 treatment.
Psychiatrists should use their clinical judgement to determine whether or not antidepressant medications should be prescribed or resumed after acute TMS treatment is completed as based on the individual patient psychiatric and medication history.
What is the history of TMS treatment?
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 studies as an antidepressant treatment.
In 2006, the largest randomized, controlled study ever conducted with TMS treatment was completed. This study was sponsored by Neuronetics and utilized the NeuroStar TMS treatment system.
The NeuroStar TMS treatment 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 treatment be covered by insurance and/or Medicare?
TMS treatment has been reimbursed by some insurance plans on a case-by-case basis.
If treatment is reimbursed, there will likely be some out of pocket costs:
- A per treatment co-pay.
- The full costs of TMS will likely not be reimbursed, if at all. You will be responsible for paying the full amount.
In the meantime, out-of-pocket payment may be required, though several financing options are available.
- Can be paid from health care flexible spending account.
- Patient financing options available through Clark Behavioral Health care Financing and the Help Card.
In a health-economic study, NeuroStar TMS treatment as compared to antidepressant medication showed favorable value to both patients and health insurance companies.
- It has favorable benefit/risk ratio compared to alternatives.
- It is associated with less hospitalizations, doctor visits, drugs, etc (data on file).
- It is one of the only evidence-based treatments for MDD patients who have not adequately benefitted from prior antidepressant medication.
- It provides a significant chance of improvement (1 in 2), despite not having adequately benefited from previous treatment attempts.
- It has no systemic side-effects, such as weight gain and sexual dysfunction.
- It is non-invasive, no anesthesia, no sedation.
- Most common side-effects are scalp pain or discomfort and headache.
Is NeuroStar TMS treatment like the magnetic bracelets?
No. There are four main differences between the magnet used in NeuroStar TMS treatment and the regular magnets used in alternative therapies:
- Regular magnets are typically weak in field strength, while the magnets used in NeuroStar TMS treatment are much stronger and the same as those used in MRI machines.
- Alternative treatment magnets create magnetic fields which do not move in space or time. The magnet used in NeuroStar TMS treatment is pulsed, which causes the magnetic fields to move rapidly over time. This rapid magnetic field movement is what induces an electric current and then stimulates brain cells.
- No scientific evidence exists to support the therapeutic benefit of regular magnets in the treatment of depression, while rigorous clinical trials have proven the effectiveness of the powerful pulsed magnetic fields used in the NeuroStar TMS treatment device.
- It provides a significant chance of improvement (1 in 2), despite not having adequately benefited from previous treatment attempts.
- NeuroStar TMS treatment is cleared by the FDA, for the treatment of depression, while regular magnets are not.
Does NeuroStar cause memory loss?
NeuroStar TMS treatment was systematically evaluated for its effects on memory.
The clinical trials demonstrated that NeuroStar TMS treatment does NOT result in adverse effects on memory or concentration.
What were the safety results of the clinical trials?
Throughout the clinical studies, more than 10,000 active TMS treatments demonstrated the safety of NeuroStar TMS treatment. The following were the safety results observed:
- No systemic side effects, such as weight gain, sexual dysfunction, sedation, nausea, or dry mouth.
- The most commonly reported side effect related to treatment was scalp pain or discomfort during the TMS treatment session.
- There was a less than 5% discontinuation rate due to adverse events.
- No seizures were reported.
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 treatment during the clinical trials.
Patients who were at high risk of of suicide were not included in the trial.
In addition, a careful analysis of the safety data showed that there was no evidence that NeuroStar TMS treatment was associated with worsening of suicidal ideation during acute treatment.
Is NeuroStar TMS treatment effective in treating other disorders?
NeuroStar TMS treatment 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.
For more information on other potential uses for TMS, contact Neuronetics Customer Service and our Medical Affairs staff can provide you with this information.
How is NeuroStar TMS treatment different from Cyberonics' VNS treatment?
VNS treatment requires a surgical procedure, during which the patient is anesthetized and has a device implanted in the neck and chest; NeuroStar is completely non-invasive.
Unlike VNS, NeuroStar TMS treatment is non-invasive and does not require surgery, anesthesia or sedation. With NeuroStar TMS, patients can return to their normal activities immediately after the typically 37 minute treatment session.
VNS treatment is approved as an adjunctive treatment to treat depressed patients who have failed at least four previous antidepressant medications. NeuroStar TMS can be used as a mono treatment and is intended to be used earlier in the treatment algorithm.
VNS is not an acute treatment; NeuroStar TMS is an acute treatment.
How does NeuroStar TMS treatment 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 it is non-invasive and has an excellent safety profile.
ECT and TMS both use 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.
TMS will likely be used much earlier in the treatment algorithm than ECT for depression patients because of its favorable risk/benefit ratio.
ECT will continue to have an important role for certain depression patients despite safety concerns; however it is usually reserved as a treatment of "last resort".
Is NeuroStar TMS treatment less effective than ECT?
NeuroStar TMS treatment has not been compared to ECT in randomized, controlled head-to-head clinical studies.
ECT is known to be an effective antidepressant but its significant side effects detract from its clinical utility for many patients.
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.
The proven effectiveness of TMS and its excellent safety and tolerability indicate that TMS will likely be used much earlier in the treatment algorithm, because of this favorable risk/benefit ration.