St. Jude Medical Receives FDA Approval for Expansion of BROADEN Deep Brain Stimulation Study for Depression

July 11, 2011 St. Jude announced its approval from the FDA to expand the study from 3 hospitals and 30+ people to 20 hospitals and 125 people. Click here for official announcement.   Here is the important (to me) quote:

"pilot study which reported that at six months, 62 percent of the patients experienced at least a 40-percent decrease in symptoms of depression as measured by a standardized test called the Hamilton Rating Scale for Depression. Of these patients, 92 percent maintained this improvement at their last follow-up visit (typically at one year)."

which is similar to the study outcomes of many of the popular anti-depressants on the market today (paxil, zoloft etc).

At the end of the article it re-iterates what I had heard - eventually they want to expand to 231 people.  (See my ramblings in the last paragraph about the odd number 231).

OH - I nearly forgot & had to re-open the post... the announcement sends you to their website to see which site might be nearby.  Um - note to STJ - the map only shows Chicago and Dallas.

A few more implanted people have contacted me.  Almost all of the DBS Depression clinical trials show Active, not recruiting.

One person who knows they are "on" for sure wrote a couple of months ago, just to say hi.  I gave them my disclaimer that I'm thrilled to hear about their experiences but couldn't / wouldn't give them more info about my experience.  They wrote back (and I hope they don't mind me sharing)

"Don't worry about your results hurting my own chances to get better. It's honestly just relieving to know someone out there is getting [some] benefit. I know this is a sloooow process and it isn't a cure-all. But hope is good.

Oh, and this: "I believe the study should provide an LPC for each of us to vent with" - ABSOLUTELY! That would be wonderful."

Again being analytical and making some calculations, I know 10 hospitals were primed and ready to go in July with a waiting list.  At 1 every other week, that would be 5 more per hospital or 50 additional to the "37" (my guess) already implanted.  If we presume the other hospitals were close to being ready, that would mean by the end of next month there should be nearly 125 of us. I AM THRILLED! Move ahead with the study - help 62% more.  (I wish the percentage were higher, but if you consider some experts estimate there are as many as 1.5 million people who don't respond to antidepressants, this will be an option for 900,000 people). [And selfishly, until the FDA approves this, my insurance will not pay for my battery to be replaced!!  Ouch!]

If we consider the other international studies, and the Medtronic studies (which I haven't heard diddly about lately) there may be over 300 of us worldwide. 

Now for some food for thought and entertainment value, watch the movie Limitless.  Consider that one of the working theories on DBS for depression is that it boosts or enhances the effects of drugs in the brain.  Consider Ritalin (and other ADD type meds) boosts or enhances executive functions (thinking).  Consider the class of drugs called Cholinesterase inhibitors which can help memory and learning.  (Cholinesterase inhibitors are alzheimer medicines).  A couple of DBS nodes in the correct area added to drugs enhancing the power of memory & cognition....  The movie calls it NZT.  It won't be long before the ethics boards are screaming.  It won't be long until someone funds the idea of neurological enhancement of IQ with a DBS device. (And you think the use of stem-cells is controversial!!!)

Now I've mentioned I'm kind of analytical, and I've had my share of graduate level statistics classes so the following is nothing more than my rambling out loud about the odd number.  Why 231? Feel free to ignore the following paragraph as me trying to second guess "them".  They started with 3 hospitals and 10 patients apiece, but I suspect some were added and some were dropped.  Rumor has it that 1 was explanted due to side effects and 1 was explanted because they felt they were 'cured'.  (explanted = $64 medical term for "removed device").  Not sure the validity of the rumors, so take it with a HUGE grain of salt.  Officially, the way I understand FDA studies, both of those had to be counted in the statistical analysis of "62% achieved at least a 40% reduction"....  So, if 62% out of 30 achieved a reduction - the math says that would be 18.6 people.  Playing with Excel to try to eliminate a .6 of a person means there are either 34, 37 or 39 of us.  Throwing in the "92% maintained improvement", leads me to believe there are really 37 or 39 or they are just rounding without decimals to be polite.  But back to the odd 231.  Typically in controlled studies, there are 2 groups - those with the real treatment and those without.  Since ultimately we ALL get turned on at some point, the 231 is an enigma.  Often though, controlled studies have multiple groups - like if you were to compare a group taking paxil (SSRI), a group taking wellbutrin (SSNI), a group receiving therapy and a group receiving nothing.  To attempt to control it, one could try to have the same demographic population (about the same ages and having gone through the same background).  Again playing with excel and the number 231, that would mean there could really be 3 groups of 77, 7 groups of 33, 11 groups of 21, 21 groups of 11, 33 groups of 7 or 77 groups of 3.  When there were 3 hospitals doing it, the 3 groups of 77 made sense. But the press release says there are 20 hospitals.  I'm just saying "they" may be studying more than just the efficacy of "gizmo" on us severely depressed.  It could be as simple as patients who have attempted suicide, those who have had a plan for suicide and those who only have thought of suicide.  (Which is much more in-depth than the Hamilton Depression Rating scale suggests).  Food for thought and shows what happens when you THINK too much!  And NOOOO I have no Ritalin nor Alzheimer medicine in my brain right now... yet :)

Some answers

I missed a couple of comments that I should have replied to, and some legitimate comments were in google's new 'junk comment' box.

Yes, my battery was changed out also right at 2 years, however I believe it was only "on" for 18 months.

From my understanding (and from what is published about Parkinson's devices) I have 2 leads - 1 on the left & 1 on the right.  Each lead has four nodes, millimeters apart.  The controller can apply voltage, frequency/amplitude to each node separately as well as be "positive or negative" (although that brings into question where its grounded - so to speak).  Additionally the device can do timing sequences like on for 12 hours, off 12 hours, etc.  One node on each side has been MRI'd and X-ray'd to be in the layer called Broadman Area 25.  (I presume they put one of the middle nodes into "the layer". The X-ray techs are extremely cocky that they guide the surgeon to land in the "exact" spot.

As for speculation, I do feel that I am doing better than 2 years ago.  But being the analytical type, I have to put that in perspective, maybe in a perspective that only someone who has suffered through years of depression can understand - If on a scale of 1 to 10 where 10 is giddly-happy, when you've lived at 1 and 2 for so many years, moving to a 4 is a TREMENDOUS improvement.  At least until you see some home movies of back 'in the day' and then you realize you are incapable of truly scaling it.

I will also admit I am feeling good enough that I have turned on the search engines and 'tags' so others can find the blog without having to go through someone else's site's links.  Should someone 'identify' me, so be it.  I have to thank my very frank friend in NM who doesn't try to hide it anymore.  It is what it is.

My understanding is that the FDA approved additional implants but still only at the 3 original sites.  I wonder if there are any policies in the FDA that at least one person is on the review board who has had whichever disease they are reviewing.  In other words, for new cancer meds, they should have a cancer victim/survivor.  For depression reviews they should have someone who has lived through it.  I have the credentials to be on such a board, if anyone from the FDA cares to pay my airfare to 'help out'.

From my 'improved' standpoint, I have had to fight old habits and routines to continue to progress.  As an example, my afternoon fatigue used to be overwhelming and no amount of Red Bull or Starbuck's shots could keep me from an afternoon siesta.  However, by using energy drinks and pushing myself, the fatigue is not as bad.  By pushing myself, I don't mean pure "willpower".  If any of us could "will" the symptoms away, we would.  But by using an energy drink and trying to stay upright an additional 10 minutes, then 15, then 20, I have made progress.  Now any good shrink would tell us that one of the techniques to fighting depression is to push yourself to do the opposite behavior that your symptoms are telling you to do.  "Feel like isolating? - time to head to the mall or call a friend.  Have no energy? - take a 10 minute walk, then 15 etc."

Great advice - but it don't work that way for some of us.  Been there, tried that and felt totally humiliated and like a failure because I COULDN'T.  Next week at the shrink - "So, how did it work for you?" Um, the darkness got darker because no matter what I tried, it didn't make anything any better and that in itself made me feel worse.  What other completely brilliant ideas do you have?


My truth is that I do feel measurably better than 2 years ago. [Happy now that I've admitted it?]  But again the caveat emptor, put on a court's stand and under oath asked if the device was what was causing the change, I couldn't say "yes without a doubt".  The meds have a LOT to do with my feeling better.  They say (they being the handlers) that one of the theories about the device is that it amps up the effectiveness of the mood altering pharmacological plethora I take.  I am at the FDA limit on 2 of my meds.  As far as I know, I'm at the FDA limit of voltage being pulsed into my head - at least by all measures I've heard of battery life.  I also stay tuned into a number of self-help programs, where I have seen nearly miraculous changes in people's lives.  So there are a lot of possibilities including the disease is just not as bad right now as it was 2 years ago. I don't know for sure.


I am adamant that the current research should be allowed to expand.  My Canadian buddy (one of the 1st controlled batch of 20) is well on their way to regaining their life completely.  They too have had to try the old suggested remedies and be diligent about their meds, but their life is better also.


An amazing statistic, is that in almost all of the major anti-depression medicine's trials, right at 2/3rds had improvement.  From what I've heard, the same is true for this treatment.  I have my SSRI which should cover 2/3rds, my SSNI should cover another 2/3rds, and with my gizmo, yet another 2/3rds should show improvement.  (For anyone doing the math, that's 6/3rds - or 2x overkill). And that doesn't even account for my Ritalin, which should make all of the remedies at least feel like they're working faster (LOL). [One of the FUNNIEST comedy bits ever is Katt Williams talking about his kid on Ritalin.  Catch it on Youtube - but keep the volume low if you've never heard him before or don't like the F-bombs].  For me Ritalin is speed - I was never ADHD.  Just ADD.  And whatever GENIUS at the FDA or insurance companies decided that adults can't have ADD is an F'n fool. (In honor of Katt's language).

As for the commenter encouraging me to divulge more,  I have.  But I'm still not going into extreme details or singing the virtues of DBS for at least 4 reasons.  1 - Anyone else in the program might be swayed by any side effects both good effects or bad effects that I report. (and I have had both).  2 - Anyone else in the program might feel "how come it worked for him but not for me?" causing a spiraling DOWN effect that I know too well.  3 - For others who are not in the program but desperately want to be, I don't want to give any false hope, nor take away hope (For many of us, hope is the only thing that keeps us alive). To them, I want this blog to fan the embers of their hope back into a flame.  Progress is being made - even if this isn't the device for them, there are now 3 other trials world-wide, targeting other parts of the brain.  4 - I am not ready to fully come out of the closet and too many details risks my own protected little world.  Besides medical personnel and other implantees, only 7 people know about it.


To the last commenter - who had their battery changed.  We're on a similar timeline, but from the IP address trail, we're from different hospitals.  Feel free to email me if you want to share details.  (Oops, the handlers may object to that). [Yes in a former life, I was a techie too]  The site still gets the most hits from the area in Canada - where the first trials took place.  Interesting. Eh? (couldn't resist the linguistic jab).


I'm still hopeful a Medtronics implantee will make contact and let me know how their project is going.  (It's ok if you have a Kia implant and I have a Cadillac!! We're both on the same road. TEASING).

Just Links

I admit I have been more busy than usual this year. Read into that whatever you like..... (one commenter on the last post said I was inferring that I was doing better).

I got no comments as to whether I should open the blog to google & yahoo for them to see the tags and direct people here. I've thought about setting up the $ google offers for being able to advertise as well - and donating it to depression charities. So I'm open to YOUR thoughts on those ideas.

I've collected a number of links of interest. The first has to do with a follow-up to the original Canadian trial of 20. I knew of 1 suicide, but apparently there were 2. Additionally 1 passed of natural causes. My condolences to the families and as odd as it may sound, my thanks. In fact my thanks goes to all 20 (and the original 6) who risked a LOT in order to promote the science. I can say though, from my standpoint of being one of the original 30 in the USA, the decision wasn't based on promoting the science as much as giving me some relief. A side note of opinion, I believe, even in my study, more should be done to avail LPCs or other therapists to the people in the study. The article is a little critical of the study but since we're talking BRAIN SURGERY, one should be very careful. The article: http://psychcentral.com/blog/archives/2011/02/08/deep-brain-stimulation-dbs-for-depression-long-term-followup/

Another interesting point the author makes is that it is impossible to do a full "sham" study. You can't take a person and 'pretend' to do brain surgery like you can give a control group a placebo pill while testing antidepressants. My study did 'sham' the first 6 months, which from my standpoint should meet criteria. I'd love to see the update on my study, but alas, that might bias me - and we wouldn't want that. (tongue in cheek comment since I don't want to bias anyone considering the surgery but apparently my writing can be interpreted as it helping). I will say I haven't had any of the really bad side effects others have reported. 1 person I keep in contact with has regained a great portion of her life. 1 has suffered bad side effects but is currently stable. 1 has had some improvement but also slid back.

The next interesting link continues the ethical discussion, specifically believing the OCD DBS should not have been given approval by the FDA. http://www.nytimes.com/2011/02/15/health/15brain.html?src=twrhp. Interesting - but again, the person suffering from the severe OCD probably has a different view of the issue.

Finally the last link of interest talks about the 3 areas of the brain that are being researched and how they now believe the 3 are 'cabled' together so the results of affecting any one of the the 3 will be the same. Um, ok. Obviously more and more research is being done. I believe it is a German study that is wiring up 4 leads into subjects brains in order to maximize their ability to find the right spot(s) or combination. Batteries in my device last from 15 months to 2 years depending on the person's settings. I can only imagine the 'power' required to turn on 4 different nodes. (Mine has 2 on and lasted 18 months). Here's the link: http://www.mtbeurope.info/news/2011/1102034.htm.

Again, shoot me an email or a comment on your thoughts on allowing the search engines to see the blog or not.

If you're in another study, I'd love to hear from you and your experiences, if you are able to talk about it.

Thanks for your support.