The BrainsWay Advantage for Treatment Resistant Depression Patients

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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. BrainsWay D is effective even in treatment-resistant depression patients.

BrainsWay Treatment vs. Antidepressants for Major Depressive Disorder Efficacy

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.

BrainsWay Treatment 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 medications.

Parameter BrainsWay Treatment 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 Treatment vs. ECT for Major Depressive Disorder patients

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 Treatment ECT
Anesthesia Not required Required
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. <sup>8</sup>

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 Treatment for Depression vs. Figure-8 TMS

BrainsWay Treatment 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 multi-center trial, which included only patients who failed to benefit from at least one prior antidepressant medication,  32.6% achieved remission following BrainsWay’s Treatment after 4 weeks vs. 14.6% with sham.

Length of treatment BrainsWay Treatment Figure-8 TMS
Single session 20 minutes 37 minutes
Full treatment course 400-600 minutes 740-1110 minutes

References:

  1. Rush AJ, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163:1905–1917.
  2. Levkovitz Y. et al. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective, multi-center, randomized, controlled trial. World Psychiatry, 2015; Vol.14, 64-73.
  3. Levkovitz Y, Harel EV, Roth Y, Braw Y, Sheer A Katz L, Gersner R and Zangen A. (2009) Deep transcranial magnetic stimulation of the prefrontal cortex – Effectiveness in major depression. Brain Stimulation2: 188-200.
  4. Isserles M, Rosenberg O, Dannon P, Lerer B and Zangen A (2011) Cognitive emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcomes. Journal of Affective Disorders 128: 235-242.
  5. Harel EV, Rabany L, Deutsch L, Bloch Y, Zangen A, Levkovitz Y. H-coil repetitive transcranial magnetic stimulation for treatment resistant major depressive disorder: An 18-week continuation safety and feasibility study. World J Biol Psychiatry 2014;15(4):298-306.
  6. Fabbri C, Marsano A, Balestri M, De Ronchi D, Serretti A. Clinical features and drug induced side effects in early versus late antidepressant responders. J Psychiatr Res 2013;47(10):1309-1318.
  7. Lawrence Park, AM, MD. (2011). Risks and Side Effects of ECT. Psych Central. Retrieved on December 3, 2014, from http://psychcentral.com/lib/risks-and-side-effects-of-ect/0007365
  8. O’Reardon JP, Solvason HB, Janicak PG, et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 2007;62:1208-1216.
  9.  George MS, Lisanby SH, Avery D, et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial.  Arch Gen Psychiatry 2010;67:507-516.