Sorting Out the Confusion Regarding Hyperbaric Applications to Various Neurological Disorders

Hyperbaric Oxygen often referred to HBOT is a well-established and accepted intervention for many disorders ranging from gangrene to non-healing skin wounds and pressure ulcers for the bedridden. However, its potential applications are much greater than then presently accepted and FDA approved indications.  Sadly, the FDA approval process is very expensive and few institutions could ever afford the process of applying and even if they did they would never recoup the cost of the research and legal expenses required to get the next indication approved for HBOT.  The technology (hyperbaric chambers capable of the pressures required) are widely available in hospitals and HBOT centers.  So anyone pushing the new indication through the FDA would be doing it for the benefit of all centers and that is an unlikely business model for success.  Even more concerning is that third party payers use the FDA approval stamp as their threshold for reimbursement, so nearly all of the possible applications of HBOT to neurological disorders goes uncovered by insurers. 

We will take a look at some of the data the FDA and insurers are blind to, but first a little about my background in hyperbaric medicine goes back to my days in the US Air Force where I was trained in Aerospace Medicine; including Hyperbarics.  I worked at McDonnell Douglas (now Boeing) and participated in research regarding F15 and F18 pilot stress and ways to improve pilot g-force tolerance.  And yes this really is me on the wing of an F18 at Naval Air Station Lemoore, California, where I received training from  Marine pilots.

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PLOS is a highly respected open-access scientific journal and this team headed by the Institute of Hyperbaric Medicine in Zefrin Israel, has put together some excellent data regarding the application of HBOT to late effects of neurological injuries (both stroke and post-traumatic head injuries).  Lets look at the delayed benefits for stroke first.

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These images indicate the area of the brain damaged by a stroke and the effect of HBOT at restoring blood flow to that region even very late after the stroke (images gathered in the study are from 6-36 months after a stroke).  But restoring blood wouldn’t mean very much if it didn’t also restore function.  Here is a quote from the abstract: “HBOT protocol: Two months of 40 sessions (5 days/week), 90 minutes each, 100% oxygen at 2 ATA. We found that the neurological functions and life quality of all patients in
both groups were significantly improved following the HBOT sessions while no improvement was found during the control period of the patients in the cross group. Results of SPECT imaging were well correlated with clinical improvement. Elevated brain activity was detected mostly in regions of live cells (as confirmed by CT) with low activity (based on SPECT) – regions of noticeable discrepancy between anatomy and physiology.”

So this is very strong data in favor of using this particular protocol for post stroke patients.  For years I have advocated 2.2 ATA (about equal to 40 feet of water pressure) but at mere room air.  One of the reasons I favor this protocol over the 100% O2 approach has to do with the blood vessel constriction that occurs with 100% O2.  That tightening of blood flow is EXACTLY what we want in acute head injuries but it has always seemed less desirable in late effects. The 2.2 room air approach has also seemed very helpful and we are seeing recovery after severe (nearly fatal) head injury in the Hyperbaric PHP Center in Buford, GA. (More information is available at their website (http://www.hyperbaricphp.com/) and I suggest contacting Bill at the center if you have more questions.

Here is another publication from the Israeli team:

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And here is the overall effect on cognition from their research.

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The real question is this: given the terrible effects of head injury and stroke on the quality of life and productivity of the individuals suffering with these conditions, why don’t insurers pay for this therapy and why doesn’t FDA take the initiative to include these treatments in their approved applications of HBOT?  When you figure that one out let me know, but my guess is it all comes down to money and more indications means more expense for the government and insurance companies.  So for now, if you need this treatment it unfortunately be at your own expense. From all we know, that expense surely seems well justified.

Parents, Teachers, Therapists, and Relatives Praise MRT Therapy for Autism Spectrum Disorders.

The following comments are from an unedited email that I received today.  I added his pre – post images but the rest is just mom-speak. “Thank you so much for introducing us to MRT. I am a private person, and I do not share things on Facebook or Twitter. However, I do want to share my experience here so that other parents will learn about MRT and gave it a try. At first I was skeptical. I watched the videos of MRT patients on Vimeo, and I thought this is too good to be true.  Well, I want to say that MRT is very good and very true.

I saw immediate improvements in my child even while we were still undergoing treatments. He had less tantrums, I was able to introduce new foods with greater ease, he began interacting with strangers, he followed instructions on the first or second request. Then in the weeks following treatments not only were his gains sustainable–they didn’t even plateau. Everyone from his school teachers, speech instructors, and our family noticed the improvements. At school, he is more focused and completes his lessons. His previous outbursts and problem behaviors are a thing of the past. At home, his sentence structure has expanded to complex 10-12 words sentences.

We are able to talk him through situations instead of having complete meltdowns. He is able to adjust to changes in routines better and is now playing with more age appropriate toys like Legos and action figures. Last week I heard him playing upstairs with his Ninja Turtles. He was acting out a complex attack scene with villains and dialogue. I had never seen him demonstrate such imaginative play before.”

HIS PRE MRT BRAIN IMAGE SHOWING FRONTAL DISCONNECT

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HIS POST MRT BRAIN IMAGE SHOWING FRONTAL CONNECTIVITY

(Especially in Language and Cognitive Centers)

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“This therapy has been such a game changer for us. I would love to do future therapy if Dr. Bradstreet recommends it. I think one day my husband and I will look back at our child’s life, and we will reference it as "pre" and "post" MRT.”

A Grateful Mom

Dr. Bradstreet’s Comments:  This is a powerful intervention and I agree that for many children it truly is a game changer. In most cases like this, we will wait a minimum of 3 months to allow the child to re-adapt to their home environment and therapies and follow those changes before we recommend further MRT sessions. Its likely this child will benefit even more from additional therapies, but it is wise to observe the trends over time.

What is MRT?  It is a process of using repetitive transcranial magnetic stimulation at very special frequencies to affect a change in how the brain communicates. 

You can learn more about it from an earlier discussion on this blog. 

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National Autism Association Conference Features Dr. Jeff Bradstreet

One of the more enjoyable places for a conference with excellent facilities and a great selection of speakers is the NAS Conference in Florida.  I strongly recommend it to everyone with an interest in Autism and I will be sharing new data on a variety of diagnostic and therapeutic approaches which promise to provide many children with renewed hope.  See you there!

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Important Autism Conference in Atlanta Area October 25: See New Location

Due to tremendous interest in this conference TACA has moved the conference to a larger venue.  The most recent findings will be presented, including new just published original research. Hope to see you there –

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My Daughter’s Wedding

On October 11, 2014 my beloved daughter Elizabeth (nickname “EB”) married Steve Harris.  Many of you have asked how the wedding went and the simple answer is it was perfect – not a glitch and they are married and back to work after their honeymoon in Grand Cayman.  I’m still trying to get my head wrapped around the idea that my daughter is married, but she is happy and that makes me happy.  So for those of you who want to know and since I don’t Facebook or Tweet, here are a few pictures of the event.

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I am a blessed Dad and I truly wish the new Mr. and Mrs. Harris the very best in life, marriage and children.

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.

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