This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. The FDA cleared BrainsWay D treatment of Major Depression in patients who failed to respond to one or more anti-depressants in the current episode.
Brainsway® has ushered in a new era in major depressive disorder treatment, with the introduction of a novel, well-tolerated and clinically proven alternative to traditional therapies. With Brainsway Deep TMS, or deep transcranial magnetic stimulation, patients can achieve significant improvement in a relatively short time, and without significant interruptions to their daily routine, and without the severe side effects that associated with antidepressants and ECT. Deep TMS is effective even in treatment-resistant depression
BrainsWay Therapy vs. Antidepressants for Major Depressive Disorder
In the NIH-sponsored STAR*D study (Sequenced Treatment Alternatives to Relieve Depression) it was found that 63.2% of patients suffering from major depression fail to benefit from the first line of antidepressant treatment. 33% of patients do not respond to any drug treatment.1
Brainsway Deep TMS was tested in patients who failed to benefit from at least one antidepressant, and was found effective even for patients who failed to benefit from several prior antidepressant medications2
|Parameter||Brainsway Deep TMS||Antidepressants|
|Side effects||The most common side effect is temporary, mild pain or discomfort at or around the site of TMS application, which occurs during treatment. This typically occurs only during the first week of treatment. There is a rare risk of seizure.*||The most common side effects include the following: Nausea, insomnia, anxiety, weight gain and sexual dysfunction, as well as diarrhea, dry mouth, and sweating. 6|
|Overall treatment term||Limited to the depressive episode, with an option for maintenance, if required.||Generally, antidepressants are prescribed for an indefinite or permanent period.|
|Clinical results achieved in||4-6 weeks 1, 3-5||4-6 weeks|
It is noteworthy that in real-life clinical practice settings, many patients receive Deep TMS therapy concomitantly with antidepressants. Continued antidepressant use is not contraindicated in patients receiving Deep TMS.
Brainsway Deep TMS vs. ECT for Major Depressive Disorder
While ECT is considered to be very effective for severe, treatment-resistant depression, no multicenter trial was conducted to evaluate the effectiveness of ECT in the treatment of major depression. It also has some downsides. Many patients do hesitate undergoing ECT (Electro convulsive therapy) due to the side effects, anesthesia and hospitalization that might be required.
Deep TMS therapy, was tested in a large, multicenter trial. And showed to be effective for patients with severe depression.
|Parameter||Brainsway Deep TMS||ECT|
|Side Effects||The most common side effect is temporary, mild pain or discomfort at or around the site of TMS application, which occurs during treatment. This typically occurs only during the first week of treatment. There is a rare risk of seizure.*||Common side effects: Cognitive and memory dysfunction, alterations in blood pressure, pain and discomfort.|
|Rare side effects: Adverse reactions to anesthesia, cardiovascular complications, death. 8|
|Session length||20 minutes||Several hours, including anesthesia and recovery|
|Overall treatment term||20-30 sessions in the acute phase||Typically 6-12 sessions, in the acute phase|
|Procedure||Non-invasive electromagnetic stimulation of brain regions||Electrically induced seizures|
|Hospitalization||None||Often requires partial hospitalization (day hospitalization)|
|Recovery time after each session||Minutes – patient can drive home independently||Hours to days|
Brainsway Deep TMS Depression Therapy vs. Figure-8 TMS
Brainsway Deep TMS is able to stimulate deeper and broader areas in the brain. Both Deep TMS and standard TMS using a figure-8 coil received 510(k) clearance from the FDA based on two separate clinical trials.
The two trials were not head to head studies and used different sham methodologies, stimulation parameters, and rating scales for depression. That said, the trials did share certain important commonalities: The patient populations of the two studies overlap with regard to demographics, clinical diagnosis, symptom severity and prior treatment failure. Furthermore, the trials applied their respective treatment as a monotherapy in medication-free patients, and compared it to sham stimulation.
In the clinical trial that led to the clearance of Neurostar TMS8, remission rates at the end of the 4-week acute treatment phase were generally low, but better with active TMS (7.1% to 9.0% vs. 6.2% to 8.2% with sham). A subsequent trial of the Neurostar device reported remission rates of 14.1% but this includes patients who achieved remission at any point during the three to six weeks acute phase.9
In Brainsway’s multisite trial, which included only patients who failed to benefit from at least one prior antidepressant medication, remission rates after 4 weeks of active deep TMS treatment were 32.6% vs. 14.6% with sham.
|Length of treatment||Brainsway Deep TMS||Figure-8 TMS|
|Single session||20 minutes||37 minutes|
|Full treatment course||400-600 minutes||740-1110 minutes|