NAMI San Mateo Lecture Jan 2015

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The latest advances in treatment of Mood and Anxiety Disorders in the 21st century:

The latest advances in treatment of Mood and Anxiety Disorders in the 21 st century Paradigm shift with trans-cranial magnetic Stimulation(TMS),a Non-Invasive, localized treatment with no surgery or anesthesia with minimum systemic side effects NAMI San Mateo, January 28, 2015

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Integrated Clinical Neuro-Sciences Co-Founder/Past president IMSA President of California TMS (trans-cranial Magnetic Stimulation) Society Member of the Board of the National/International TMS Society Chief Medical Officer, Silicon Valley TMS, Formerly Adjunct Clinical Associate Professor Emeritus of Psychiatry and Behavioral Medicine. Stanford University, California. Medical Director, Silicon Valley center for Medical weight loss (CMWL) Director, Silicon Valley Integrated Sleep Center Private practice group (locations), Los Gatos & San Francisco SAAD A. SHAKIR, MD, DFAPA, FACIP www.siliconvalleytms.com www.saadshakirmd.com

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Los Gatos Office: 14651 S. Bascom Ave. Suite 230 Los Gatos, CA 95032 P: (408) 358-8090 F: (408) 358-3940 shakirmd@verizon.net

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San Francisco Office: 595 Buckingham Way Suite 450 San Francisco, CA 9432 P: (415) 294-4090 F: (415) 294-4089 svtmssf@gmail.com

Why Depression is so Important?:

Why Depression is so Important? “ In the 21st century depression will surpass all other medical disorders as the number one illness in the world ” W.H.O., 2001.

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1. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry . 2000;157(4 Suppl ):1-45. AMERICAN PSYCHIATRIC ASSOCIATION 1 “ The goal of treatment with antidepressant medications in the acute phase is the remission of major depressive disorder symptoms. ”

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THE CANADIAN PSYCHIATRIC ASSOCIATION in conjunction with THE CANADIAN NETWORK FOR MOOD AND ANXIETY TREATMENTS 1 “In clinical practice, it behooves us to adequately assess and treat depressive and anxiety disorders to remission.” 1. O ’ Donovan C. Can J Psychiatry . 2004;49(March Suppl 1):5S-9S.

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1. Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guidelines Team for Depression. Aust N Z J Psychiatry . 2004;38:389-407. AUSTRALIAN AND NEW ZEALAND CLINICAL PRACTICE GUIDELINES 1 “ The aim of treatment is to achieve and maintain remission. ”

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1. Möller HJ. WHO Regional Office for Europe. Health Evidence Network report. 2005. WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR EUROPE 1 “ The goal of acute treatment should always be the complete remission of the episode and not just partial improvement. ”

Phases of Treatment:

Phases of Treatment Adapted from: Kupfer DJ. J Clin Psychiatry. 1991(May);52(suppl):28-34 Maintenance Continuation Acute Full Recovery Severity Time Response Relapse Recurrence Treatment Phases Symptoms Remission Syndrome Relapse Progression to disorder No Depression

Depression Is a Chronic Illness:

50% 80% 90% Depression Is a Chronic Illness 0 50 100 Probability of Recurrent Episodes (%) After 1 Episode After 2 Episodes After 3 Episodes Kupfer DJ. J Clin Psychiatry. 1991(May);52(suppl):28-34

Challenges:

Challenges 1.Poor Recognition 2.Underdiagnosis and misdiagnosis 3.Overutilization of healthcare resources(non-Psychiatric)

Why are Mental Health issues Undiagnosed or Under diagnosed?:

Why are Mental Health issues Undiagnosed or Under diagnosed? Mental illness stigma Crisis in health care financing(Time constraints: 7-11 minutes/patient ) Clinical diagnosis is difficult Clinical picture varies: sad, angry, anhedonic Disease is cyclical Many criteria on which to judge diagnosis Primary care patients/physicians focus on somatic complaints(on avg. have 1-2 months training in MH) Sleep disturbances  Weight loss/gain Fatigue  Headache Back pain  Gastrointestinal symptoms

Physical Symptoms as main reason for office visit to primary care provider :

Simon GE, et al. N Engl J Med . 1999;341:1329-1335. Physical Symptoms as main reason for office visit to primary care provider Primary Care Patients With Major Depression (N = 1146) symptoms

“Consequences” Impact of Untreated/Undertreated Depression:

“ Consequences ” Impact of Untreated/Undertreated Depression Morbidity Comorbid medical illness(worse health) Suicide attempts Accidents Mortality >35,000 suicides per year Fatal accidents Death due to related illness (substance abuse/accidental OD) Societal and functional burdens Dysfunctional families Divorce Substance/Alcohol abuse Absenteeism Decreased productivity/Present- eeism Job-related injuries(higher rates of Workman’s comp.) Lost jobs Failure to advance in career or school Preskorn SH. Outpatient Management of Depression: A Guide for the Primary Care Practitioner. 2nd ed. Caddo, Okla: Professional Communications, Inc; 1999:chap 2.

Impact on Health and Wellness of untreated Depression :

Impact on Health and Wellness of untreated Depression

Effects of Depression on Medical Disorders( multiple studies supporting these findings):

Effects of Depression on Medical Disorders( multiple studies supporting these findings) Depression increases likelihood of development of coronary artery disease(heart disease) Depression worsens outcome after myocardial infarction(heart attacks) Depression increases risk of stroke Depression worsens outcome post-stroke Depression may increase risk of other medical disorders including diabetes, cancer, arthritis Depression may worsen outcome of cancer, diabetes, AIDS, and other disorders(Immune disorders ,allergies, etc..) Depression increases risk of cognitive issues and Dementia

Depression and MI’s (Heart attacks):

Pratt LA et al. Circulation. 1996(Dec);94(12):3123-3129 Depression and MI’s (Heart attacks) 1,551 individuals without heart trouble at baseline were studied from 1981-1994 444 individuals had a history of major depression or dysthymia at baseline Patients with a history of depressive disorders had a 5-fold increased risk of cardiac mortality independent of other coronary risk factors

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Cumulative Mortality for Patients with and without Depression After Heart Attack N=222( pts admitted for MI to CCU) Frasure-Smith N, Lesperance F, Talajic M. JAMA. 1993(Oct);270(15):1819-1825 0 5 10 15 20 25 30 0 1 2 3 4 5 6 Mortality (%) Months After Heart Attack Depressed (N=35) Nondepressed (N=187)

RISK FACTORS FOR DEPRESSION AND ANXIETY:

RISK FACTORS FOR DEPRESSION AND ANXIETY GENETIC SOMATIC PSYCHOLOGICAL ENVIRONMENTAL Neuro -chemical/electrical imbalance SYSTEMIC ILLNESS CHRONIC PAIN, ENDOCRINE DISORDER( hormones,thyroid etc.) FAMILY HISTORY ( 2015 criteria) Childhood trauma, LOW SELF-ESTEEM, POOR COPING SKILLS e.g., UNEMPLOYMENT, DIVORCE, ABUSE, BEREAVEMENT

Innovations & Advances in Clinical Neuro-Sciences:

Innovations & Advances in Clinical Neuro -Sciences

2015 -The Science (in neuro-Sciences):

2015 -The Science (in neuro-Sciences)

Functional Neuro-Imaging(fMRI)(metabolic scans) Regional Glucose Metabolism in MDD:

Functional Neuro-Imaging(fMRI)(metabolic scans) Regional Glucose Metabolism in MDD Drevets WC . Curr Opin Neurobiol . 2001;11:240-249.

Brain atrophy(reversible!) in depression as seen on MRI (structural):

Brain atrophy(reversible!) in depression as seen on MRI (structural) Bremner JD, et al. Am J Psychiatry 2000;157(1):115-118. Reprinted with permission from JD Bremner. Atrophy of the Hippocampus in Depression NORMAL w/ DEPRESSION

Medical Treatment Requires Understanding:

Medical Treatment Requires Understanding Neurotransmitters offer a crucial conceptual bridge between the mind and the brain .

Axon Terminals Of Serotonergic Neurons Project To Virtually All Portions Of The Brain(and Nervous system):

Axon Terminals Of Serotonergic Neurons Project To Virtually All Portions Of The Brain(and Nervous system)

Serotonergic Neuro-transmission a look at a synapse :

Serotonergic Neuro -transmission a look at a synapse TCA SSRI { Reuptake Postsynaptic Receptors Presynaptic 5-HT Neuron Synapse 5-HT 1A 5-HT 1D 5-HT 1A 5-HT 1B 5-HT 1C 5-HT 1D 5-HT 2 5-HT 3 5-HT 4 (rodent only) Auto receptors 5-HT 1D/1A 5-HT 5-HT 1A

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Stimulation of: 5-HT 2A Behavioral activation, insomnia, anxiety, sexual dysfunction 5-HT 2C Irritability, decreased appetite 5-HT 3 Nausea, headache and emesis Side Effects Associated with Serotonin Receptor Stimulation

Kaplan and Sadock. Synopsis of Psychiatry, Behavioral Sciences, Clinical Psychiatry. 6th ed. 1991 (revised).:

Norepinephrine Innervation Of The CNS Kaplan and Sadock. Synopsis of Psychiatry, Behavioral Sciences, Clinical Psychiatry . 6th ed. 1991 (revised).

DOPAMINE “pleasure Neuro-transmiter”:

DOPAMINE “ pleasure N euro-transmiter ” Enhances signal Improves attention Focus On-task behavior On-task cognition . Nigrostriatal Pathway Mesolimbic Pathway Substantia nigra Ventral tegmental area Mesocortical Pathway Dopamine

Reduced Neurotransmission and Neural Adaptability:

Reduced Neurotransmission and Neural Adaptability Metzner,UCLA 2000

IN THE 21ST CENTURY WE DISCOVERED ELECTO-CHEMICAL CIRCUITS IN THE BRAIN INVOLVED IN NEURO-REGULATION OF SYNAPSES THAT CONTROL MOOD AND ANXIETY DISORDERS:

IN THE 21 ST CENTURY WE DISCOVERED ELECTO-CHEMICAL CIRCUITS IN THE BRAIN INVOLVED IN NEURO-REGULATION OF SYNAPSES THAT CONTROL MOOD AND ANXIETY DISORDERS

Anatomy and Circuitry of Depression/Anxiety (21 st Century insights) Neuronal Networks Implicated in Neuro-Psychiatric Illness:

Anatomy and Circuitry of Depression/Anxiety (21 st Century insights) Neuronal Networks Implicated in Neuro -Psychiatric Illness Tye S., et al. Disrupting Disordered Neurocircuitry: Treating Refractory Psychiatric Illness with Neuromodulation . Mayo Clinic Proceedings. 2009;84(6 ):522-532.

2015 The ART (in Neuro-Sciences):

2015 The ART (in Neuro -Sciences)

“Designer” Treatment of the 21st Century :

“Designer” Treatment of the 21st Century “ Black Bile ” ECT/Analysis TCAs MAOIs SSRI/ SNRIs/atypicals 1st Century 1900 1930s 1950s 80s / 90 s NOW TMS d-TMS

TREATMENT OPTIONS for depression & Anxiety disorders:

EVIDENCE-BASED TREATMENT OPTIONS for depression & Anxiety disorders

Current Depression Treatment Options(Evidence based) 2015:

Current Depression Treatment Options(Evidence based) 2015 Nonpharmacologic Psychotherapy Cognitive behavioral therapy Interpersonal therapy Psychodynamic therapy DBT,EMDR … Electroconvulsive therapy(Shock therapy, ECT, EST) 1950’s Phototherapy(Light Therapy for SAD)2000 Rapid transcranial magnetic stimulation (r-TMS)FDA- 10/08 Deep(d-TMS)-10/13(FDA cleared 1/13) Vagus nerve stimulation(VNS/2005) Deep Brain Stimulation(DBS/experemtl.) Pharmacologic Antidepressant medications

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Classes of Antidepressants TCAs MAOIs SSRIs SNRIs Others

(More)Selective Antidepressants:

(More)Selective Antidepressants Types Generic( BRAND) Serotonergic • Citalopram (CELEXA) • Escitalopram (LEXAPRO) • Fluvoxamine ( LUVOX) • Fluoxetine (PROZAC) • Paroxetine (PAXIL) • Sertraline (ZOLOFT) Catecholaminergic • Bupropion ( WELLBUTRIN XL,SR) Dual Mechanism/atypical AD • Venlafaxine (EFFEXOR) • Mirtazapine (REMERON) .Duloxetine (CYMBALTA )2002 . Desmethylvenlafaxine (PRISTIQ )2005 .Vilazadone (Viibryd )2009 .Veroxetine(Brintellix) Nov.2013 .LevoMilnacipran(Fetzima)Nov 2013

But Wait Do We Have Effective Anti-Depressants?:

But Wait Do We Have Effective Anti-Depressants? That are well tolerated? And Work often ? And produce full recovery”Remission ”?

IN SPITE OF THE DISCOVERY OF PATHWAYS Adequate Treatment Is Difficult to Achieve:

IN SPITE OF THE DISCOVERY OF PATHWAYS Adequate Treatment Is Difficult to Achieve Nemeroff (1996/1997) Depress Anxiety ; Oquendo (2003) J Clin Psychiatry ; Oquendo (1999) Am J Psychiatry . Adequacy of treatment has been estimated to be as low as 18%, regardless of agent used The ratio of inadequate-to-adequate treatment attempts is 4:1 …adequate treatment in depression is the exception, not the norm Adequate Dosage Adequate Duration Poor tolerability Lack of adherence to recommended treatment Lack of efficacy Medical and Psychiatric Comorbidities Factors contributing to inadequate treatment include: Unmet Medical Needs

STAR*D Trial (Sequenced Treatment Algorithms for Depression):

Clinical Update STAR*D Trial (Sequenced Treatment Algorithms for Depression)

STAR*D Trial Study Design:

STAR*D Trial Study Design

STAR*D Treatment Algorithm Examining Different Treatment Strategies in a “Real World” Setting:

STAR*D Treatment Algorithm Examining Different Treatment Strategies in a “Real World” Setting

STAR*D (sequenced treatment alternatives to relieve depression) Study demonstrates that current treatment has limited effectiveness(NIMH):

STAR*D (sequenced treatment alternatives to relieve depression) Study demonstrates that current treatment has limited effectiveness(NIMH) Trivedi (2006) Am J Psychiatry ; Rush (2006) Am J Psychiatry ; Fava (2006) Am J Psychiatry ; McGrath (2006) Am J Psychiatry Unmet Medical Needs 51

Likelihood of discontinuing treatment increases with each new medication attempt:

Likelihood of discontinuing treatment increases with each new medication attempt Systemic Drug Side Effects Weight Gain Constipation Diarrhea Nausea Drowsiness Insomnia Decreased Libido Nervous Anxiety Increased Appetite Decreased Appetite Fatigue Headache/ Migraine Abnormal Ejaculation Impotence Sweating Tremor Treatment Discontinuation Side Effects Weakness Dry Mouth Dizziness Trivedi (2006) Am J Psychiatry ; Rush (2006) Am J Psychiatry ; Fava (2006) Am J Psychiatry ; McGrath (2006) Am J Psychiatry ; Neuronetics , Inc. (data on file) Unmet Medical Needs 52

HELP! :

Solutions ? Technology (to the rescue) HELP!

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Neuro -modulation (a shift in paradigm/direction) in the Treatment of Resistant Depression

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In the 1970’s-1980’s Magnetic Resonance Imaging (MRI)Technology was mostly diagnostic until…………

TMS appeared Historical Timeline IN THE MODERN MEDICINE ERA :

TMS appeared Historical Timeline IN THE MODERN MEDICINE ERA First Generation Technology 1985 – Tony Barker, PhD demonstrates first single pulse TMS system for non-invasive cortical stimulation to investigate cortical function with single pulse device. 1 Third Generation Technology May 2008 – Neuronetics introduces new FDA cleared NeuroStar TMS Therapy technology with supporting published clinical evidence to psychiatry community. Seven peer reviewed publications support its use as new clinical tool for major depression. 1 Barker, AT, et al, Lancet, 1985 Second Generation Technology 2000 - Two companies began to offer TMS research devices with high frequency stimulation capability (Magstim, Dantec). The image above is of the Dantec, now MagVenture, device.

What is r-TMS? (Rapid Transcranial Magnetic Stimulation):

What is r-TMS? (Rapid Transcranial Magnetic Stimulation) Faraday demonstrated electric currents can be converted into magnetic fields=electromagnetism Electric energy in insulated coil induces MRI-strength magnetic fields Magnetic fields pass unimpeded through the cranium for 2-3 cm In turn inducing an electric current in the brain This stimulates the firing of nerve cells and the release of neurotransmitters such as Serotonin( 5HT),Norepinephrine (NE), and Dopamine( DA)

Based on 2010 APA practice guidelines and NeuroStar TMS Therapy® indication for use.:

Based on 2010 APA practice guidelines and NeuroStar TMS Therapy® indication for use . Adapted from: Practice Guideline for the Treatment of Patients with Major Depressive Disorder, 3 rd Edition, APA (2010) Unmet Medical Needs Best Practices Treatment Guideline for Depression

NeuroStar TMS Therapy (FDA–cleared Oct 08) :

NeuroStar TMS Therapy (FDA–cleared Oct 08)

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Major Depressive Disorder prefrontal cortex In MDD, some areas of the brain are hypoactive and others are hyperactive. amygdala brainstem neurotransmitter centers thalamus striatum anterior cingulate cortex hippocampus hypothalamus LOW HIGH Neural Activity

Major Depressive Disorder: Circuits and Neurotransmitters:

When there is an appropriate amount of monoamine neurotransmitter activity, neuronal activity throughout the brain functions normally. Monoamine dysfunction is linked to MDD Malfunctioning circuits lead to specific symptoms Major Depressive Disorder: Circuits and Neurotransmitters Serotonin (5-HT) Dopamine (DA) Norepinephrine (NE) Monoamine Neurotransmitters monoamine neurotransmitter projections concentration pleasure/ interests guilt suicidality worthlessness mood sleep appetite psychomotor fatigue (physical) pleasure/interests psychomotor fatigue (mental) guilt suicidality worthlessness mood Regions implicated in MDD are connected to the brainstem via monoaminergic circuits

When taking an oral medication(anti-depressant):

When taking an oral medication(anti-depressant) There is a Systemic effect ” Shotgun approach”

Chemical Antidepressants:

Chemical Antidepressants Antidepressant weight gain sexual dysfunction insomnia nausea GI distress blood pressure changes blurred vision Antidepressant Therapeutic Effects such as : Side Effects such as: improved mood increased concentration reduced feelings of guilt, suicidality , and worthlessness weight gain insomnia agitation dry mouth fatigue

On the other hand TMS (NeuroStar )Directly Depolarizes Cortical Neurons:

Neuron On the other hand TMS ( NeuroStar )Directly Depolarizes Cortical Neurons Pulsed magnetic fields from NeuroStar: induce a local electric current in the cortex which depolarizes neurons eliciting action potentials causing the release of chemical neurotransmitters Neurons are “ electrochemical cells ” and respond to either electrical or chemical stimulation

NeuroStar Releases Neurotransmitters in the Brain:

NeuroStar Releases Neurotransmitters in the Brain Depolarization of neurons in the DLPFC causes local neurotransmitter release Depolarization of pyramidal neurons in the DLPFC also causes neurotransmitter release in deeper brain neurons Activation of deeper brain neurons then exerts secondary effects on remaining portions of targeted mood circuits Dorsolateral prefrontal cortex Anterior cingulate cortex Kito (2008) J Neuropsychiatry Clin Neurosci These effects are associated with improvements in depressive symptoms

Targeted Effects on Mood Circuits in Brain:

Activation of fronto-cingulate brain circuit following a course of TMS applied to the left dorsolateral prefrontal cortex in patients with Major Depression Targeted Effects on Mood Circuits in Brain Kito (2008) J Neuropsychiatry Clin Neurosci TMS Coil L L R R A Proven Approach 66

Transcranial Magnetic Stimulation (TMS):

Transcranial Magnetic Stimulation (TMS) The treatment coil produces MRI-strength magnetic field pulses. Magnetic field pulses pass unimpeded through the cranium for 2-3 cm. and induce a small electric current. Induced electric currents stimulate the firing of nearby neurons, causing the release of neurotransmitters and clinical effects. Faraday (1839) Experimental Research in Electricity . Vol 1; Barker (1991) J Clin Neurophysiol ; Barker (1985) Lancet A Proven Approach 67

Neurostar TMS Therapy in Clinical Practice:

Neurostar TMS Therapy in Clinical Practice The first TMS device FDA-cleared for the treatment of depression in US Non-invasive and non-systemic The most common side effect associated with treatment is scalp pain or discomfort – generally mild to moderate Outpatient procedure, can be performed in a psychiatrist’s office; no anesthesia or sedation 37.5 minute treatment, administered daily for 4-6 weeks Observed therapy facilitates adherence with treatment Available by prescription only A Proven Approach 68

TMS is Included in Practice Guidelines Following Failure of Initial Treatment:

TMS is Included in Practice Guidelines Following Failure of Initial Treatment Schlaepfer , et al. World J Biol Psychiatry (2009); Kennedy, et al J Aff Disorders (2009); Institute for Clinical Systems Improvement (2010); American Psychiatric Association (2010) Guideline Sources World Federation of Societies for Biological Psychiatry (2009) Canadian Network for Mood and Anxiety Treatments (2009) Institute for Clinical Systems Improvement (2010) Guideline Sources American Psychiatric Association (2010) “ … Acute phase treatment may include pharmacotherapy, depression-focused psychotherapy, the combination of medications and psychotherapy, or other somatic therapies such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or light therapy… ” Where It Fits 69

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Private Practices Institutions NeuroStar TMS Practice Locations >530 Systems Installed as of Jan. 2015

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SILICON VALLEY TMS WWW.SILICONVALLEYTMS.COM Fastest growing and busiest center in Northern California 3 locations(Los Gatos, Mountain view,& Danville,SanFrancisco SUMMER 2014!) 4 Neurostars & 2 Brainsway (deep TMS) International Center of Excellence Saad.A.Shakir, M.D. medical director(founder) >25 clinicians/technical integrated team including MD,NP ’ s,Psychology,Counselors,Nursing etc. Many Patients already treated very successfully

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SILICON VALLEY TMS WWW.SILICONVALLEYTMS.COM Fastest growing and busiest center in Northern California Opened in Los Gatos January 2011( Neurostar ) 2 nd Treatment system added Jan. 2012( Neurostar ) 3 rd Treatment system ( Neurostar ) Jan. 2013 Deep TMS( brainsway ) added October 2013(first on west coast) San Francisco office opened Nov.,2014(Both Neurostar (4 th ) and Brainsway deep TMS(2 nd ) “International Center of Excellence”2013 Saad.A.Shakir,MD medical director(founder) 20 clinicians/technical integrated team including MD,NP ’ s,Psychology,Counselors,Nursing etc. Many Patients already treated very successfully

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Patient Profile Overview Majority of the patients are between 21 – 65 years of age 56% patients are male and 44% are female Average HAMD21 score of the patient pool in the sample was 34 before the TMS therapy >80% of patients have MDD and a third of them have co-existent anxiety disorder Most of the patients are resistant to other depression treatments Overview of Patient Profile,( Neurostar for depression),Presented at APA in San Francisco, May 2013 Age Gender Disease Profile of Patients Treatment(Non TMS) Background of Patients % of Patients % of Patients Type of Disease Type of Patient Age & Gender Distribution

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Effectiveness Of TMS Therapy Is Evident From The Significant Reduction In Patients With Severe/Moderate Scores Burn ’ s Depression Score Pre-TMS Post-TMS 70% ↓ in Severe/Moderate PHQ-9 Depression Score Pre-TMS Post-TMS 85%↓ in Severe/Moderate Burn ’ s Anxiety Score Pre-TMS Post-TMS 65%↓ in Panic/Severe/Mod.

Silicon Valley TMS(some of our staff):

Silicon Valley TMS(some of our staff)

Brainsway Deep TMS:

FDA approved in US Jan 2013 for MDD Marketing/production July 2013 1st in Northern California at Silicon Valley TMS Oct 2013! Brainsway Deep TMS Newest Innovations in technology Deep r-TMS

Brainsway:

Brainsway Wide FDA indication for treating Major Depressive Disorder, including patients who failed to benefit from any number of antidepressant treatments* Convenient outpatient treatment – No anesthesia or hospitalization; just 20-minute sessions over a course of 4 weeks Safe - No long-term side effects, no systemic effects Patented by the U.S. National Institutes of Health (NIH) Over 60 clinical trials in leading institutions worldwide

The H-Coil - Unique Patented Coil Structure :

The H-Coil - Unique Patented Coil Structure Brainsway technology is based on a patent registered by the U.S. National Institutes of Health (NIH), and Brainsway has an exclusive license from the NIH for both the patent and the technology. Return paths of electrical impulses located remotely from target area. Coil elements parallel to target bundles. Convergence of numerous electric pulses from various directions. Flexible base suited to head shape. Coil elements tangential to the head and close to target brain regions.

Deep TMS – 250% Deeper than 8 coil:

Deep TMS – 250% Deeper than 8 coil Deeper Stimulation: Brainsways H-Coil is 250% deeper than Surface TMS (reaching only 1.5 cm into the brain). Electric fields generated by Figure 8 Coil vs. H1 Coil * *Each cell is 1cm

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Depth and Connectivity

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Brainsway Neuronetics * Brainsway's Deep TMS technology has been cleared by the FDA for the treatment of Major Depressive Disorder in patients who tried any number of antidepressant medications in the current Depression episode. ** CE approved MDD * MDD OCD Smoking** Bi-polar** PTSD** Autism** MS Alzheimer** Pain** ADHD Obesity Tourette Schizophrenia** FDA Approval Reimbursement Parkinson** Epilepsy Brainsway’s Product Pipeline Strategy*

Brainsway Deep TMS MDD Multicenter protocol:

Brainsway Deep TMS MDD Multicenter protocol = 20 minutes per session 2 2 2 2 2 2 2 2 2 2 2 2 5 5 5 5 Sessions per weeks M aintenance Acute Treatment

Brainsway Results Summary(for depression/anxiety) 6 Months, 40 PATIENTS(Nov 2013-April 2014:

Brainsway Results Summary(for depression/anxiety) 6 Months, 40 PATIENTS(Nov 2013-April 2014 SILICON VALLEY TMS, presented at APA, NYC, May 2014 In Depression & Anxiety

DEMOGRAPHICS:

DEMOGRAPHICS AGE : 68% 21-65 Yrs , 16% 14-20 Yrs, 16% 66-82 Yrs GENDER:56% Males, 44% Females Prior treatment with rTMS ( Neurostar ):62%, new to TMS 38% Outcome, 60% completed, 40% still in treatment (as of April 4, 2014)

RATING SCALES :

RATING SCALES

PATIENT HEALTH QUESTIONNAIRE -9 (PHQ-9)DERPRSSION SELF RATING SCALE:

PATIENT HEALTH QUESTIONNAIRE -9 (PHQ-9)DERPRSSION SELF RATING SCALE SEVERE 21-30 MODERATE 11-20 MILD 6-10 MINIMAL < 5

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% of Patients

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PHQ-9 Scores: Change from Baseline

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90 BURNS ANXIETY INVENTORY ( bAi ) Severe = 31-40 Moderate = 21-30 Mild = 11-20 Minimal ≤ 10

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BAI(Anxiety) Results: (Anxiety avg.20 treatments)

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BAI Scores: Change from Baseline

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As a few months ago(July 2013) a new device called deep rTMS (d rTMS ), a device that has an H-coil technology that can penetrate into deeper parts of the brain than conventional (surface) may be very effective in Addiction . Brainsway deep rTMS r esearch team led by Prof. Abraham Zangen from Ben Gurion University in Israel concluded. Breaking News New Coil Goes Deeper

GOOD NEWS!!!!! THE FUTURE IS BRIGHTER:

GOOD NEWS!!!!! THE FUTURE IS BRIGHTER

THANK YOU QUESTIONS???? (408)358-8090 shakirmd@verizon.net :

THANK YOU QUESTIONS???? (408)358-8090 shakirmd@verizon.net

For more information www.SiliconValleyTMS.com, www.saadshakirmd.com, or www.NeuroStar.com or www.brainsway.com :

For more information www.SiliconValleyTMS.com , www.saadshakirmd.com , or www.NeuroStar.com or www.brainsway.com Thank you!

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