Brainsway Deep TMS Therapy - for Brain Disorder Treatment

The Brainsway Advantage for Treatment Resistant Depression

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 Deep TMS (Transcranial Magnetic Stimulation) 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.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

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. 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.

In the clinical trial that led to the clearance of Neurostar TMS, 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) and the difference relative to sham was not statistically significant in any of the clinician-administered depression rating scales used. A subsequent trial of the Neurostar device reported remission rates of 14.1% after 4 weeks, but this includes patients who achieved remission at any point during the acute phase, even if remission was not sustained at the end of the treatment course. 6

The latter study also used MRI-guided visual inspection to verify positioning of Neurostar figure-8 coil over the left DLPFC. Coil position was adjusted in 30% of the subjects, who would have received TMS outside the target area entirely but for this correction procedure.

In Brainsway's multisite trial, which included only patients who failed to benefit from at least on prior antidepressant medication, response and remission rates after 4 weeks of treatment were 38.4% and 32.6%, respectively.

In real-life clinical practice settings, 20 sessions of Deep TMS produce remission rates even higher than those observed in randomized controlled clinical trials. Among patients who went on to complete a treatment course of 30 sessions, 1 in 2 achieved full remission, suggesting a definite benefit for patients completing the full 30-sessions treatment regimen.

 

 

Length of treatment

Brainsway Deep TMS

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 Stimulation 2: 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.     Levkovitz Y et al. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective, multi-center, randomized, controlled trial. World Psychiatry 2014; in press.
8.     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

 

* Read more about safety in risks associated with Deep TMS treatment by clicking here

 


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