The Magnetic Resonant Therapy (MRT™) Autism Research Study Finishes Today: The Results Are Remarkable.

I had the privilege of serving as the principal investigator or PI for the double-blind, sham-controlled investigation of the effects of a special form of transcranial magnetic stimulation therapy as an intervention for autism. [ClinicalTrials.gov Identifier:NCT01985308].  I started collaborating up with Prof. Jin and the BTC in California about a year and half ago after MRT had already shown positive effects in several of my patients. I want to thank all the families for their dedication and efforts in helping this most important research project. Without them, none of this would have been possible. The study was financed by the Newport Brain Research Laboratory. 

Professor Yi Jin of the Newport Brain Research Laboratory and the Brain Treatment Center in Newport Beach, California, developed a different theory about the way the brain functions and how it uses harmonic energy to synchronize its communications. That led him to develop a new system of transcranial magnetic stimulation now known as MRT™.

Dr. Yi Jin presented the preliminary results of the study at the Autism One Keynote address in May 2014.  At that time we all were still blinded and did not know which patients comprised the curves in the graphic below.  I served as one of the raters and Dr Toni Jin was another rater of the outcomes.  She and I were always very close with our independent assessments which is reassuring that the effects observed are both consistent and real.  A link to more of Dr Jin’s Autism One presentation is here. The link will further describe the study design. http://braintreatmentcenter.com/pdf/052614_PR_MRT001_GRAPHS.pdf

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The graphs illustrate the difference in effect in the sham versus treatment group in the first 5 weeks of treatment, and also show the similar response to treatment once the sham group initiated treatment after 5 weeks.  The orange line represents the average outcomes from the group of children starting with sham treatment – at 5 weeks they moved into regular MRT daily treatments. The likely reason for the subtle downtrend in the sham group is the conditioning of the children to daily life in the center. The blue line represents the group of children starting with and continuing with treatment.  That group received a total of 10 weeks of treatment. The composition of the groups includes the data from the ~20% of children in either group who failed to respond to therapy. The work continues so we can find ways to reach the 20% non-responder group of children. Both myself and Dr. Toni Jin, despite being blinded to the sham versus treatment status of the children, were able to reliably detect the effect of MRT. More about the special magnetic coil used in the study a little later in this blog. But first what the experts think about this work. 

WHAT NEUROSURGEONS ARE SAYING ABOUT MRT

“What the Brain Treatment Center has done is revolutionary. Using evidence- based principles with TMS, they have created a delivery system that customizes treatment based on the patient’s own QEEG. Addressing the core frequency mismatch that occurs in various parts of the brain, and not the patient’s symptoms per se, allows this system to be potentially useful in numerous psychological and neurological disorders, from autism to Alzheimer’s.” Dr. Kevin T. Murphy, Associate Professor and Vice Chair of the Department of Radiation Medicine and Applied Sciences, UC San Diego Medical Center.

This noninvasive, personalized form of neuromodulation is very patient specific, and has far-reaching clinical implications”. Dr. Charles Liu, Professor of Neurological Surgery, Neurology, and Biomedical Engineering and Director of the University of Southern California Center for Neurorestoration, Los Angeles, California.

COMMENTS FROM PROFESSOR YI JIN ABOUT THE MRT AUTISM STUDY

80% of the kids in the study had huge improvements (30% reduction in Autism symptoms measured by Childhood Autism Rating Scale) and 40% are neurotypical by CARS in just 10 Weeks of MRT.  We understand this is a relatively small (N =28) study which cannot be generalized to apply to the entire population of Autism.   These findings, however, very closely resembled our clinical data of over 700 cases treated at our centers from 2005 to present.  Both UCSD and Rady Children’s Hospital are aware of our MRT-001 study results and have just been approved for a large (N=400)  MRT-003 double-blind study to validate our preliminary findings.  We know this is limited but we believe this is a very important beginning of a novel treatment for Autism.

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http://www.braintreatmentcenter.com/staff [either click on the link or paste it into your browser to see Dr. Jin’s Autism One presentation]

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Dr. Bradstreet present recent neuroscience advances at Autism One in Chicago in May 2014.

WHAT A MOTHER OF THREE CHILDREN WITH AUTISM THINKS ABOUT THE MRT STUDY AT BTC ATLANTA

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I have had the pleasure of working with the mother of 3 children with moderate to severe autism for a few years now. Ashley, an Audiologist, has twin girls born at around 25 weeks (very premature) and a younger boy born at 35 weeks.  All three have been diagnosed with Autism and all three participated in the study at BTC Atlanta.  She has worked for years restoring her kids with diet and trying to heal the GI tract with various interventions. All of that helped as a basis what came next – MRT. A link to her interview is on Vimeo at http://vimeo.com/97462194 . (either clink on the link or paste it into you browser).

Kara with Study Coil

Kara at the BTC Atlanta Center with the unique study coil and MRT technology. The coil was designed to reproduce the clicking sound of the magnet without actually creating any magnetic discharge.  A computer remotely controlled the study based on a randomly assigned and coded patient number.  Even the treating tech could not tell which arm of the study was being used for a given child. After 5 weeks all children were receiving MRT. This was the open phase of the research.

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Dr. Bradstreet with MRT study staff: Jijeong (from the Newport Beach BTC office), Beth and Kara (from BTC Atlanta) – our team all had a chance to celebrate the success of the study. Other BTC- CA staff helping on the study and not pictured here were Carlos, Christine, and Kevin and Kim – thanks to all of them.  Alex at the BTC in California stayed behind the scenes with Dr. Bob Silvetz – both of whom were instrumental in the study.

Toni Jin Study

We are all indebted to Dr. Toni Jin – MRT Study Research Coordinator, put in long hours to make sure all the details were properly recorded.

If you are interested in learning more about MRT you may contact the BTC office in Newport Beach – Phone: (949) 851-3086.

The BTC- Atlanta office is located in the Northeast Atlanta metropolitan area near the Mall of Georgia:  4486 Commerce Dr, Suite B, Buford, GA 30518. The phone for that center is 678-765-8427.

Dr. Bradstreet’s medical practice is located in the adjacent building and may be contacted at 678-288-9222.

 

 

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Prelude to my upcoming Autism One lecture on the INCREDIBLY important ENDOCANNABINOID SYSTEM

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Teri from Autism One Radio interviews Dr Bradstreet about the Autism Nexus.  Listen here by clicking on the link below.

http://podbay.fm/show/324695865/e/1395375892?autostart=1

See you at Autism One in Chicago.

In Defense of 23andMe.com – why knowing your genome is important

Up until November of 2013 the controversial 23andM.com website offered people the opportunity to get genomic insights to their past and their possible future – at least their future vulnerabilities.  After 2 years of back and forth communication wherein it seems 23andMe was trying (unsuccessfully) to convince the FDA that people had the right to genomic information the FDA issued a cease and desist order and now 23andMe states this on their homepage: “23andMe provides ancestry-related genetic reports and uninterpreted raw genetic data. We no longer offer our health-related genetic reports.” 

The price of the testing dropped dramatically and is now only $99 for a salivary genomic test.  The problem is that unless you actually care what percentage of your ancestral DNA comes from what continent or how much residual Neanderthal your parents contributed to you, the raw data is merely a huge outpouring of A,T,C G data (nucleic acid pairs) which even a competent geneticist would find daunting without the aid of serious computer databases.  But therein lies its wonder – we do have access to amazing databases which offer us glimpses into the rapidly expanding arena of medical genomics and personalized health care. 

Enter in a support industry growing up around 23andMe like livewello, which offers an app for downloading all those ATCG codes and converting them to more easily understood labels, like MTHFR – a gene with common single nucleotide substitutions which may result in dramatic reductions in its enzyme’s ability to methylate folate (a completely treatable genetic risk factor for heart disease, certain cancers and autism). 

 

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The livewello gene app for 23andMe only costs $15 and equally they do not provide you with any specific health recommendations or interpretations.  But they do add a filter which makes it easier to identify the genes on the OMIM website.  OMIM is part of the the US National Library of Medicine and it is an invaluable tool. 

However, there is a catch. 23andMe and livewello (or any of the other gene apps) only identify SNPs and do not adequately look at copy variances and deletions. Still there is useful information, which in knowledgeable hands can give helpful information.

In the near future, (like after Autism One and IMFAR) I will write up an interpretation guide for the primary genes I find helpful and with that I hope to further all of our understanding of the emerging field of personal genomics.  Remember – knowledge is power – what you do with that power can change your life in important ways through the use of informed choices. 

Clinical Trial on the Use of a Unique Form of Transcranial Magnetic Stimulation – MRT for the Treatment of Autism is Nearing Completion – Results to be Presented at Autism One 2014 in Chicago.

Clinical trial NCT01985308 (details available at www.clinicaltrials.gov) or directly at http://www.clinicaltrials.gov/ct2/show/NCT01985308?term=bradstreet&rank=1 is in its final stages of completion.  The preliminary results of the study will be presented during the Autism One conference upcoming in Chicago in May ( http://www.autismone.org/content/2014-autismone-conference ). MRT uses powerful magnetic pulses to stimulate the brain is unique ways.  The outcomes from the early use of MRTwere recently presented by Prof. Yi Jin, the developer of this type of therapy at the annual AANS meeting.

 

I’ve had the pleasure of working the Brain Treatment Center team including various technicians Prof Jin and his sister Dr. Toni JIn for the past several months on this project. The study has been arduous and Toni has put in some amazingly long hours to help the parents, the children and me with this complex area of research.

The study recruited 28 subjects with autism ages 4-12 and entered them into a 12 week program.  The treatment required frequent EEG testing and examinations. The magnetic (MRT) portion was based on the EEG findings and uniquely tailored for each patient by the assessments of individuals neurophysics (electronic signature of the brain).  The study had/has two arms with each group being randomly assigned to either 5 weeks of sham and then 5 weeks of treatment and the other group getting 10 continuous weeks of treatment. Everyone remained blinded and the seal on the numerical codes will not be broken until the end of the study.

I hope you join Drs Jin and myself at Autism One for a look at the use of MRT for autism.  For more information about MRT you may visit http://vimeo.com/braintreatmentcenter/videos and if this is something you feel may apply to your child you may contact my office for a consultation.  MRT, a form of TMS, is only available by prescription and requires the supervision of a physician. The FDA has approved TMS for the treatment of refractory depression. It is not approved for the treatment of other disorders including autism and its use is considered an off-label application of the technology which is permitted in the US. Additional research is expected to start in the next 12 months at UCSD regarding its use in autism.

International Interest in Stem Cell Therapies for Autism Continues to Grow Amidst Ongoing Controversies

I am pleased to announce today’s publication in the World Journal of Stem Cells of our review of Mesenchymal Stem Cells (MSCs) for the treatment of autism.  Our team representing Italy, the US and Ukraine, reviewed the evidence and present understandings of this important class of stem cells and what we know about its potential and rationale for autism therapeutics. We also discuss various struggles, including regulatory restrictions in various countries, for the present application of the MSCs to autism treatment. Here in the US I routinely extract adipose derived stems cells (mostly MSCs) for the treatment of arthritis – primarily knee joint degenerative disease. This is a relatively simple application of stem cell therapeutics and I am about to publish our initial outcomes from this.  I DO NOT HOWEVER TREAT AUTISM WITH STEM CELLS HERE IN THE US. I use EmCell in Ukraine for advanced autism related cell interventions.  Together with the EmCell team, I have submitted our outcomes in the autism population for publication and it should be available soon in print. If after reading this article – via the link below – you are interested in stem cell therapies, you may contact my office to set a time for consultation.

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The Link to the Public and Freely available article is here: http://www.wjgnet.com/1948-0210/pdf/v6/i2/173.pdf

The Autism Nexus: New Discovery of a Link Between the Gut Microbiome, the Immune System, Brain Dysfunction and Vitamin D and Vitamin D Binding Protein (GcMAF)

I am very proud of our recent work published in the highly regarded Journal of Inflammation.  http://www.jneuroinflammation.com/content/11/1/78  By clicking on the hyperlink you browser should take you straight to the article which is available for no cost at the journal’s website. Once you are there click on the pdf button (the yellow arrow shows you where to click once you get to the article on the web).  Before you jump to article page let me explain in easier language why this article is so important. It is the first article any of us as authors have written that was accepted without any critique or changes, which means the reviewers thought very highly of it. While that is important, it is only part of the significance of our findings.  It has always bothered me that minor changes on the gut bacteria and yeast (microbiome) could result in wild and crazy changes in a child’s behaviors. While that observation is common among those of us treating the biology of autism, it was actually very difficult to understand mechanistically at the level of the child’s biology, at least until now.

We believe we have uncovered the nexus (intersection) of the observations regarding Vitamin D deficiency, GcMAF observed improvements in behavior, see: http://www.la-press.com/initial-observations-of-elevated-alpha-n-acetylgalactosaminidase-activ-article-a3450 , immune dysregulation, brain inflammatory changes (mostly in microglial regulation), and the microbiome.  Briefly, the endocannabinoid system is part of the cell systems that regulate the immune system and the brain. In particular, it seems the CB2R (cannabinoid 2 receptor) reads the background environment of the individual (diet, microbiome, etc) and sets the tone of the immune defenses.  Last year we published the first observations of CB2 dysfunction in autism (J Autism Dev Disord. 2013 Nov;43(11):2686-95. doi: 10.1007/s10803-013-1824-9.). With this follow on work it seems likely that the endocannabinoid system is at the center of the complex biomedical disruptions underpinning the autism epidemic we are observing.  Now for your homework. Go the Journal of Neuroinflammation website and get the entire article. After you read it you can ask you questions. (use the link provided in the first paragraph).

 

JNI Article facepage

CDC data show continued rise in autism spectrum prevalence for Autism Awareness month

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You can download the entire article and go over the statistics for yourself but here are a few of the outstanding observations these data offer us.

1) The ADDM site prevalence has risen to 2.38% of boys and 0.5% of girls, although in figure 4 of the report it goes as high as 2.75% of boys.

2) The median age of diagnosis of autism was 53 months (4 years 5 months).

3) The disorder is diagnosed more frequently in the white non-Hispanic population

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You won’t be able to read this chart on your mobile phone very easily, but the data are certainly terrible for our children.

As a background in statistics, 10 case per 1000 in prevalence equals 1%, so the prevalence for both boys and girls combined in the sum of the ADDM areas was: White non-Hispanic 1.58%, Black 1.23%, Asian 1.23%, Hispanic 1.08%.  The overall ratio of boys to girls was 4.76 to 1.

Based on the available scientific literature it is difficult to explain the nearly 5 fold increased risk of ASD observed in the make population. The simplistic observation would be to look at the Y (male) and X (female) chromosomes and see what is happening there.  Very few autism risk factor genes have been identified on either chromosome apart from fragile X which accounts for only a small percentage of ASD cases. This implies some epigenetic (gene-environment) interaction wherein males show more vulnerability than the females. Finding these factors has been elusive, but a new study may give us some clues.

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The American Journal of Human Genetics. 94, 415–425, March 6, 2014

This is a complex study, but the apparent observation is that females have significantly higher numbers of small copy-number variants (CNVs) in the DNA (more mutations) but have less risk of autism – meaning being female somehow lends protection to the gene variations and implies males are more sensitive to genetic variations.  As with previous studies these factors are NOT occurring on the sex chromosomes, but rather on the other chromosomes.  They also observed higher levels of neurodevelopmental risk factor genes in the mothers compared to the fathers of the children with ASD, which was again consistent with the view that females tolerate a higher burden of CNVs than males.

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The odds ratio of having a neurodevelopmental associated gene CNV was 3 times higher for females than males (15% compared to 5%). However, only 308 of 4482 males (6.87%) tested in this study actually had CNVs detected.  So even this study fails to explain on a genetic basis the genetic risks of autism for the majority of cases.

This leaves us still searching for the combination of genes and environmental factors triggering this incredible and frightening rise in ASD observed in the most recent CDC study. I will be presenting more on this at Autism One in Chicago this year.

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