neurodiagnostics and magnetic eeg-guided resonance therapy
TRANSCRIPT
Spring 2021Confidential; not for distribution
Neurodiagnostics and Magnetic EEG-guided Resonance Therapy (MeRT)
Disclaimers● Dr. Erik Won does not have a personal financial relationship with the manufacturer of the EEG products or services that will
be discussed in this CME Activity or in this presentation.
● Dr. Erik Won will support this presentation and clinical recommendations with the “best available evidence” from medical literature
● Dr. Erik Won is an officer and shareholder of Wave Neuroscience, Inc.
NIMH RDoC : Research Domain Criteria
While DSM has been described as a “Bible” for the field, it is, at best, a dictionary, creating a set of labels and defining each.
Patients with mental disorders deserve better.
NIMH has launched the Research Domain Criteria (RDoC) project to transform diagnosis by incorporating genetics, imaging, cognitive science, and other levels of information to lay the foundation for a new classification system. ”
Thomas Insel, M.D., April 23, 2013
Director of National Institutes of Mental Health
Paradigm shift
Diagnosis-Based Paradigm• DSM-V Clusters of
Symptoms• Talk Therapy & Medication
Management
Functional Paradigm• Targets Root Cause• Strives to Optimize Function
HOW IT WORKS
15 minute recording in a quiet, dark room.
Measured biorhythms include brain activity, heart rate, and heart rate variability.
Medical oversight is not required to take an EEG, reports are provided within 24-48 hours.
qEEG as a Predictive Biomarker
● The American Neuropsychiatric Association endorsed qEEG as an adjunct for diagnosing depression highlighting studies demonstrating sensitivity of 72-93% and specificity of 75-88%1
● The American Association of Neurology recommends qEEG to assess learning disorders (90% sensitivity and 96% specificity for ADHD)2,3
● Quantitative Electroencephalogram (qEEG) was compared to New Orleans Criteria (NOC) and National Emergency X-Radiography Utilization Study II (NEXUS II) Rules in predicting intracranial bleeds on head computed tomography (CT) in acute mild traumatic brain injury in the emergency department (ED)4
○ N=152; 17.1% had acute traumatic intracranial lesions on head CT. ○ Sensitivity of QEEG discriminant score was 92.3 (95% CI, 73.4-98.6), specificity 57.1 (95% CI,
48.0-65.8). ○ All instruments had sensitivity > 90%, but QEEG discriminant score had superior specificity
compared to NOC (15.8) and NEXUS II (31.7).
1. Coburn KL, et al. Value of Quantitative Electroencephalography in Clinical Psychiatry: A Report by the Committee on Research of the American Neuropsychiatric Association. J Neuropsychiatry Clin Neurosci. 2006;18:460–500.
2. Bresnahan SM, etal. Specificity of quantitative EEG analysis in adults with attention deficit hyperactivity disorder. Psychiatry Res. 2002;112:133–1443. Nuwer M. Assessment of digital EEG, quantitative EEG, and EEG brain mapping: Report of the American Academy of Neurology and the American Clinical Neurophysiology
Society. Neurology. 1997;49:277–292.4. Ayaz SI, et al. Comparison of quantitative EEG to current clinical decision rules for head CT use in acute mild traumatic brain injury in the ED. Am J Emerg Med. 2015
Apr;33(4):493-6. doi: 10.1016/j.ajem.2014.11.015. Epub 2014 Nov 20. PMID: 25727167.
Phase-Based Amplified MRI (aMRI), NIH Directors Blog
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NIH Directors Blog, June 21st, 2018 https://directorsblog.nih.gov/2018/06/21/brain-in-motion/Reference: Revealing sub-voxel motions of brain tissue using phase-based amplified MRI (aMRI). Terem I, Ni WW, Goubran M, Rahimi MS, Zaharchuk G, Yeom KW, Moseley ME, Kurt M, Holdsworth SJ. Magn Reson Med. 2018 May 30
Repetitive Transcranial Magnetic Stimulation – CEPAC Report
CEPAC is a regional body whose goal is to provide objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions across New England.
At its meeting in December, 2011, CEPAC reviewed the AHRQ evidence review on rTMS and voted that the evidence was adequate to demonstrate that rTMS, was as good as or better than existing care for patients with treatment resistant depression (drugs + psychotherapy)
CEPAC = Comparative Effectiveness Public Advisory CouncilAHRQ = Agency for Healthcare Research and Quality
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Neuromodulation (Non-Invasive)Safety Profile
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Neuromodulation (Non-Invasive)Safety Profile
“In summary, based on ex vivo and in vivo studies, it appears that TMS can be safely applied to patients...it is worth noting that exposure to electro-magnetic fields appears safe at levels even greater than those possible with TMS (Gandhi, 2002; Martens, 2007)”
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Neuromodulation (Non-Invasive)Side Effects & Adverse Events
● Temporary discomfort/pain at scalp
● Headache
● Overstimulation (excitation)
● Seizure (estimate 1:10,000 – 1:500,000)
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Personalized Protocols for rTMSMeRTWave Neuroscience has developed an innovative method called Magnetic EEG-guided Resonance Therapy (MeRT) that can:
• Render a 3D qEEG image of brain function unique to each individual
• Inform specialists which areas of the brain are affected by abnormal neuronal activity
• Create a personalized treatment protocol (adjusting frequency, location, waveform to the individual) utilizing low intensity non- invasive neuromodulation
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Step 1: Record
We measure biorhythms that include your current brain activity, heart rate, and heart rate variability.
Step 2: Analyze
Review your report with a trained clinician. From there we determine customized settings to individualize TMS for your brain.
Step 3: Treat
Relax and receive treatment for 30 minutes. After 20 sessions, we take another recording to compare your brainwave activity to its baseline recording
EEG-guided (Personalized) TMS - How it works
Quantitative input from EEG recordings guide and personalize neuromodulation, increasing efficacy and demonstrating impact.
EEG guidance is the key to unlocking neuromodulation’s potential and will enable far greater adoption
“Merging TMS and EEG facilitates future innovations leading to personalized treatments based on biological markers, I am confident this will lead to better patient outcomes.”- Dr. Alvaro Pascual-Leone (Harvard University)
Leading Institutions Believe In EEG-Guided Neuromodulation
WHY NOW
Articles citing EEG as a guidance tool for TMS
16
Expected TBI/Concussion TBI/Concussion
Sleep
ADDRESSING THE SOURCE OF THE ISSUE
40-time
Bio-mechanics
Strength
Hormones / Blood Biomarkers
Most Critical Organ -Neurophysiology (Quant)
Symptoms
Brain Disruption
Behaviors
Anthropometrics
MeRT Effectiveness – Brain Health / Neuro-Optimization
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Data Source :Universal Health Services (Nevada)
Data Source: Del Mar Pilot (San Diego)
Data Source: Universal Health Services (Nevada)
Data Source: Special Operations Care Fund & Tomahawk
Data Source: USSOCOM RCT, Phase 1 (MacDill AFB, San Diego)
Data Source: Del Mar Pilot (San Diego)49% Improvement
54% Improvement
57% Improvement
67% Improvement
68% Improvement
68% Improvement
78% Improvement
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
PTSD (PCL-M)
TBI/Concussion (RPQ16)
TBI/Concussion (RPQ16)
Anxiety Symptoms (HAM-A)
Sleep (PSQI)
Depression Symptoms (PHQ-9)
Depression Symptoms (PHQ-9)
% Symptom Improvement
Universal Health Services (Nevada)
Brain Treatment Center (Multi-Center)
Del Mar Pilot
Universal Health Services (Nevada)
SOC-F Pilot
USSOCOM (Phase 1)
Del Mar Pilot
Wave vs. The Field - Disrupting the “Status Quo” in Brain Care (% Improvement)
Glossary:
PHQ-9 = Patient Health Questionnaire 9
PSQI = Pittsburgh Sleep Quality Index
Hamilton-Anxiety Rating Scale (HAM-A)
RPQ16 = Rivermead Post-Concussion Questionnaire
rTMS = repetitive Transcranial Magnetic Stimulation
PCL-M = Post-Traumatic Checklist Military
12%
49%
22%
57%
33%
67%
21%
68%
31%
78%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Status Quo (rTMS)
PTSD (PCL-M)
Status Quo (rTMS)
TBI/Concussion (RPQ16)
Status Quo (CBT + Drugs)
Anxiety Symptoms (HAM-A)
Status Quo (Ambien/Zolpidem)
Sleep (PSQI)
Status Quo (Multi-Disciplinary Program)
Depression Symptoms (PHQ-9)
Personalized treatment protocols produced safer and more profound results
J. Corlier et al. / ICON-DB, Brain Stimulation 2020CL Roelofs et al. / ICON-DB, Clinical Neurophysiology, 2021
Targeting Intrinsic Alpha Frequency (IAF) improved results 2X over non personalized treatments
International Consortium on Neuromodulation –Discovery of Biomarkers (ICON-DB) Study
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At visit F1, 68/72 subjects had improved in RPQ-16, and 53 subjects (74%) had improved by at least 8.5 RPQ units – the pre-defined clinically
meaningful effect size. By visit F2, all 70 subjects had improved in RPQ-16, and 58 subjects (83%)
had improved by at least 8.5 RPQ units.
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Human Performance Outcomes: Improved Sleep Quality & Recovery
Pittsburgh Sleep Quality Index (PSQI – A) Sham group (n=35)
Baseline average PSQI-A of 9.34 +/- 4.6 After two weeks average PSQI-A of 7.29 +/-4.8 Average improvement of 2.1
Treatment Group (n=36) Baseline average PSQI-A of 10.58 +/- 5.0 After two weeks average of 5.83 +/- 4.9 Average improvement of 4.6
Significant gains in restorative properties of sleep
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Human Performance Outcomes: BrainCheck
3rd party computerized neurocognitive battery (FDA cleared, meets standards established by American Academy of Neurology)
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Human Performance: Heart Rate Variability (HRV)
HRV is a measure of the variation in time between each heartbeat. This variation is controlled by a part of the nervous system called the autonomic nervous system (ANS). HRV is considered a proxy for emotional resilience.
42 year old Executive, Recreational Athlete56 year old Chief Executive Officer33 year old Professional Athlete
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Precision MedicineNeurocomputational analytics enables personalization of treatment for each individual● Data effect that creates increasing efficacy at the person and population
level● Heuristics and machine learning to improve clinical outcomes● Automated protocol generation allows scalability
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Array of constant Q filters provide detection of intrinsic resonance during resting state.
A new time/frequency filter is constructed and convolved with the entire EEG sample so that the influence of all pairwise correlations can be measured and integrated for predictive equations and components.
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Magnitude of energy from filters applied to all possible pairs of discreet recording sites (bipolar potentials). When n = 19, m = n * (n-1) /2, thus m = 171. This is for about six minutes of an EEG recording.
Expanded from 50 to 5 second x division and not expanded further here, but there is a modulation of activity about 1 time per second. The source of this modulation is also the topic of the Cardio project. If you can see the little black dots on power peaks they are times when microstates are most clearly defined. Data to compute covariance is only measured at power peaks
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Improved Functional Outcomes - Testimonials
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Comprehensive Addiction and Recovery Act of 2016 (CARA)Public Law 114-198, Section 931(b)(3)(K)
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AUGUST 17, 2020
Individual frequency can be used to specifically influence certain areas of the brain and thus the abilities processed in them - solely by electrical stimulation on the scalp, without any surgical intervention.
AUGUST 18, 2020
Fifty million people globally sustain a TBI every year, with an estimated yearly cost of around $400 billion. TBI may significantly impact a person's social, cognitive, emotional, and behavioral functioning, which may hamper a return to previous roles.
JULY 2020
Magnetic Resonance Therapy is already being tested by the USSOCOM... is a non-FDA approved therapy that uses a combination of EEG reading, neuro stimulation from transcranial magnetic stimulation therapy and an algorithm developed by the Brain Treatment Center (Wave Neuro) to treat TBI. MRT is a non-invasive treatment that has shown promise in improving cognition in TBI patients.
AUGUST 17, 2020
Autism’s diverse influences may all affect the same neural circuits, or networks of neurons that work in concert. “As we get a picture of what the circuits are, and potentially how to target them and modulate them, I definitely think [manipulating circuits] is an avenue that is promising,”
MAY 20, 2019
They use magnetic therapy for veterans who have PTSD, CTE, because there’s areas of the brain that you can stimulate with very powerful magnets… Cat Zanganu was having some serious problems with her brain and they fixed it with magnets, electromagnetic pulses… they throw these waves at the brain and and somehow or another these magnetic waves stimulate areas of the mind and somehow forces brain-cells to grow and forces neural connections
MARCH 2018
As peak alpha frequency reflects the integrity of neural networks, our results suggest that deviations in network development may underlie cognitive function in individuals with ASD.
OCTOBER 3, 2019
Additionally, equipping electroceutical treatments with sophisticated algorithms that will allow adjustments to treatment analogous to dosing by a pharmaceutical agent could help overcome drug adherence concerns and potentially be adapted to patient-specific circumstances.
Momentum
