Given the clinical diversity and the unknown origin of the Mayor Depressive Disorder (MDD), it is difficult to establish the pathophysiological bases.
No standardized hypothesis has been yet determined about the beginning of depression. Actually, such hypothesis could vary during the course of the disorder. Current theories are based on several research studies:
- Psychosocial stress hormones and stress
- Glutamate, GABA, serotonin, adrenalin among another neurotransmitters
- Neurotrophic factors
- Circadian rhythms
Genetic factors do have an influence (30% - 40%) on the origin of the disorder. No-genetic factors influence from 60% to the 70% remaining and depend on the variation of the individual susceptibility to depression and on adverse events during childhood or at any age due to abuse, constant stress, rapes, interpersonal problems, low social support, etc.
MDD is a frequent and expensive disorder that is generally associated with severe and persistent symptoms that limit psychosocial activity and increase mortality. It is one of the most important causes of worldwide disability. The high rate of inappropriate treatment is still a serious problem.
Sensitivity to stress, in this disorder, is gender specific. The response to depressive symptoms varies depending on the stressor. Depression is more frequent in women than in men in a ratio of 2.5 to 1.
In functional imaging studies (Magnetic Resonance, Positron Emission Tomography, Magnetoencephalography…) or necropsy studies, there is consistent proof of alterations in the limbic system.
Neuromodulation, in the Neurosciences field, merges different neurological disciplines that are integrated into physics, chemistry and engineering. In turn, such disciplines are linked to the world of technological research, giving it the necessary support for the creation and development of new devices.
Neuromodulation has invasive and non-invasive procedures. Among the former, there are functional neurosurgery techniques. Among the non-invasive, and therefore of first choice, there is Transcranial Magnetic Stimulation.
The therapy system through the use of Transcranial Magnetic Stimulation was approved for the non-pharmacological treatment of depression in 2008. Since then, under the orders of Dr. Sanjuán, the treatment has been applied to several hundred of patients with a MedtronicMAG-PRO 100 System at Clínica San Vicente of brain rehabilitation with an acceptable response rate although with a duration of less than 60% compared to deep Transcranial Magnetic Stimulation (as it has been found both in research and clinical settings).
Neuroanatomic and neurobiological research in depression has not ceased, resulting in clinical, pharmacological and technological interest. With the development of deep repetitive Transcranial Magnetic Stimulation (deep TMS, BrainsWay), targets in the depth of the brain have been selected for specific regions, allowing the modulation of the reward-circuits to ameliorate psychiatric symptoms.
It is a new technology approved in Europe, USA, Canada, Japan, some South American countries, among others, with significant success in Resistant and regular Depressions.
It is an adjuvant alternative of complementary therapy, with a different way of conceiving and stimulating the brain being also part of conventional methods.
dTMS is aplied on an outpatient basis. It is safe and effective, since the results obtained between improvements and cures are 71%. It is non-invasive, and therefore, there is no need of hospitalization or anesthesia. It does not entail side effects or memory loss (as a side effect from Electroconvulsive Therapy – ECT). Sessions last around 20 minutes and are administered daily for four weeks. Sometimes it needs to be supplemented with sessions every 15 days during three months.
Daily contact and the 11-year experience with superficial Transcranial Magnetic Simulation, guarantee the best use of dTMS.
BrainsWay Major Antidepressant Effect
Studies have shown that depth and wide range of stimulated brain structures have a great important impact on treatment effects since:
- Different neurological and psychiatric behavioral manifestations are not only an abnormality in a certain region of the brain, but they represent brain networks and connectivity alterations
- Ventral prefrontal structures have more significant connections with reward areas compared to prefrontal structures.
- There is a significant interindividual variety in the location of the exact functional connectivity of the ventral dorsolateral prefrontal areas with the subgenual cingulated gyrus (Fox et al., 2012)
- An effective response for Resistant Major Depression is strongly related to functional connectivity in resting state between the left prefrontal ventral dorsolateral region and the subgenual cingulated (Biological Psychiatry, 2012)
- Individualized targeting becomes less important when there are larger sizes of stimulation fields (Fox et al., 2012)
Advantages of deep Transcranial Magnetic Stimulation BrainsWay
BrainsWay has developed a new tool to address depression offering a secure, effective and well tolerated alternative. With deep TMS, patients can obtain a significant improvement in a short period of time, without interrupting daily life activities.
DEEP TMS BRAINSWAY VS ANTIDEPRESSANTS
*Side effects of medication when entering the bloodstream and circulating throughout the body
**In certain cases, BrainsWay treatment requires the patient to take antidepressants.
DEEP TMS BRAINSWAY VS ELECTROSHOCK
DEEP TMS BRAINSWAY VS SUPERFICIAL TMS
Deep TMS BrainsWay System was the first indication approved in January 2013 by the Federal Drug Administration (FDA) for the treatment of resistant depressive episodes in adults who did not get a satisfactory improvement with antidepressant medication. Since then, disorders such as Multiple Sclerosis, Obsessive Compulsive Disorder or strokes, have been authorized in North America and Europe as the results of clinical trials that have been conclusive.
North American approval data: FDA 510 (k) No. 122888. BrainsWay.
Efficacy of Brainsway Deep TMS for Depression
Levkovitz Y, Harel EV, Roth Y et al. Deep transcranial magnetic stimulation of the prefrontal cortex—Effectiveness in major depression. Brain Stimul 2009;2:188–200. Isserles M, Rosenberg O, Dannon P et al. Cognitive emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcomes. J Affect Disord 2011;128:235–42.
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 May;15(4):298-306.
Rosenberg O, Zangen A, Stryjer R et al. Response to deep TMS in depressive patients with previous electroconvulsive treatment. Brain Stimul 2010;3:211–217.
Rosenberg O, Shoenfeld N, Zangen A et al. Deep TMS in a resistant major depressive disorder: A brief report. DepressAnxiety 2010;27:465–469.
Rosenberg O, Isserles M, Levkovitz Y et al. Effectiveness of a second deep TMS in depression: A brief report. Prog Neuropsychopharmacol Biol Psychiat 2011;35:1041–1044.
Levkovitz Y, Isserles M, Padberg F, Lisanby SH, Bystritsky A, Xia G, Tendler A, et al. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial. World Psychiatry 2015;14(1):64-73.
Harvey PO, Van den Eynde F, Zangen A, Berlim MT. Neural correlates of clinical improvement after deep transcranial magnetic stimulation (DTMS) for treatment-resistant depression: a case report using functional magnetic resonance imaging. Neurocase. 2015;21(1):16-22.
Berlim MT, Van den Eynde F, Tovar-Perdomo S, Chachamovich E, Zangen A, Turecki G. Augmenting antidepressants with deep transcranial magnetic stimulation (DTMS) in treatment-resistant major depression. World J Biol Psychiatry. 2014;15(7):570-578.
Multicenter trial leading to Brainsway's FDA Clearance for Treating Depression
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.
Tolerance and Side Effects of Brainsway Deep TMS
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.
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.
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.
Maintenance of Deep Transcranial Magnetic Stimulation are associated with reduce depressive relapses in patients with unipolar or bipolar depression. Chiara Rapinesi, Francesco Saverio Bersani, Georgios D Kotzalidis, Claudio Imperatori, et al. Frontiers in Neurology, 09 Febero 2015/ fneuro. 00016
Efficacy of Antidepressants
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.
Side Effects of Antidepressants
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.
Risks and Side effects of ECT
Lawrence Park, AM, MD. (2011). Risks and Side Effects of ECT. Psych Central. Retrieved on December 3, 2014
Daily Left Prefrontal Repetitive Transcranial Magnetic Sstimulation for Acute Treatment of Medication-Resistant Depression. Marck S. George, MD; Robert M. Post, MD. The American Journal of Psichiatry. September 07, 2010
Prevalence of Depression
Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry 2005;62(6):617-627.
Brainsway's FDA Clearance
FDA 510(k) No. K122288
Deep brain structures' connections with other reward systems
Neuropsychopharmacology (2008) 33, 368-377; Doi: 10.1038/sj.npp.1301408; published online 11 April 2007. Thomas E Schlaepfer, Michel X Cohen, Caroline Frick, Marcus Kosel et al.