Saturday, May 3, 2014

DBS for Depression Studies
Map of 24 studies found by search of depression and "deep brain stimulation" -parkinson -anorexia -obsessive ...  from ClinicalTrials.gov
16 of these are considered 'Open', as in either recruiting or about to be. (Map should be clickable, Click "Open" for just the open ones).

In the latest paper released with  Dr. Mayberg, Patricio Riva-Posse, MD, Emory assistant professor of psychiatry and behavioral sciences says "...results suggest that clinical outcome can be significantly influenced by optimally modulating the response network defined by tractography," [Um, that's a mouthful, but I'm going to translate in laymen: 'using the latest in neuro-imaging, there is a real good chance we can pinpoint exactly where the brain needs some stimulation']

(added... a shorter synopsis



Precise brain mapping can improve response to deep brain stimulation in depression

A new study using MRI analysis of the white matter connections examined the architecture of this network in patients who demonstrated significant response to SCC DBS. (Source: Emory Eniversity)
So what do these pretty pictures and map have to do with each other? Everything for the future of DBS and mental illness (not just Depression).  In the map above, I excluded anorexia, OCD et al.  (Not all studies will proceed and I am sure not all studies are listed).

So the race is on.  The German-Bonn (Nucleus Accumbens) studies look "rewarding" and are moving to the Americas (UT Houston), but Bonn is continuing to chart new frontiers; while Emory is "focusing" in on reliable mapping.  Although I haven't heard anything lately, I'm sure the Cleveland Clinic still has their "head" in the game. (Bad puns intended.)

Locations mentioned in clinical trials:
  • Nucleus Accumbens
  • Subcallosal Cingulate 
  • Internal Capsule 
  • Superolateral Branch of the Medial Forebrain Bundle (slMFB)
  • Ventral Caudate Nucleus
  • Inferior Thalamic Peduncle
The studies seem to be split between the 2 major medical stimulation device manufactures although I can find fewer results from the Medtronics group.  I am not a Doctor nor Neuropsychologist so these are layman's extrapolations/interpretations/translations.

Now for my usual optimistic but caveat emptor: anyone considering being involved in one of these MUST fully understand the potential risks.  Here is a YouTube video of a fellow Brodmann participant that describes his terrible experience related to the surgery and follow-up care.  However even he verbalizes optimism for the research towards the end at 14:10; calling for more oversight, not an end to the studies.  Good luck Steve, and thanks for trying to pioneer this forward.  I hope something can be done soon for both your pain and for the depression. [Stanford - wake up! In my opinion, your inability to rectify this situation is soiling your name, the study's name (which needs no extra soiling at this point), and the worst - possibly contaminating future studies. And yes, I have seen Stanford  IP addresses view my blog, so I'll know when you see this - same for you ANS].

And though I don't like to give advice, here is my 2 cents on my study's current dilemma via a suggestion I recently had:  Get the exact details, in writing, of what happens if the study is cancelled.  Will they continue to provide replacement units if your insurance won't?  The question is NOT what happens if the FDA doesn't approve it - although you need to ask that as well, but even if the FDA approves it and your insurance company won't pay for a replacement.... 


6 comments:

Max said...
This comment has been removed by the author.
Max said...

Great stuff. I'm responding to the latest comments posted on the Expectation page. The newest Google group is a "closed" group, meaning you have to be invited to join. It is ONLY for Depression DBS patients. Reply with an email if interested. It may take me awhile to get back with you though - be patient. Or I think 278-005 can direct you.

278-005 said...

This is for you Steve:
5/13/2014. 14:47:06 Stanford University (171.66.219.128)
Safari 6.0 MacOSX 1280x800 United States Flag Stanford, California, United States

Og said...

Yes I know some Mac users there, many of them

Og said...

Even if you have in writing what happens when the study is canceled you are not protected.
FYI While in the early months of the Broaden Study, Stanford was wooing Dr Schlaepfer from Bonn Germany to get him to come to Stanford. He is targeting a different area of the brain, made me wonder, wholly shit maybe they targeted the wrong part of the brain in ME.

herb said...

Hi 278-005,

It’s been awhile since I last checked in here. How are you doing? I truly hope you’ve improved.

While we can never be what we once were at the very least I do hope you’re in a better place than the depths of despair prior to your adventure.

I was pretty busy at one point battling the wonderful bureaucracy in D.C. namely CMS (Centers for Medicare and Medicaid Services) to get Medicare/Medicaid medical coverage for a number of the VNS study subjects and patients.

I don’t know what you folks signed when you entered into your respective study sites but I want to make you are aware and hope that the sponsor is responsible for your medical costs of the implanted prosthesis in the event the FDA does not approve the device. Then I hope they remain responsible should the FDA approve the therapy and CMS denies coverage.

Some of the wonderful loopholes the sponsors and bureaucracy (FDA and CMS) omit informing the study subjects when signing up to participate. For me the battle continues as the bureaucratic department heads are exiting and a new crew of bureaucrats (paper pushers and number crunchers) comes to power without the slight bit of knowledge or understanding of patient challenges and needs.

As always I wish you all wellness and all the good you’d wish for yourselves.

Sincerely,
Herb
vnsdepression@gmail.com
http://www.vnstherapy-herb.blogspot.com
http://www.vnstherapy.wordpress.com

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