July 5, 2011

Research Study 4th Visit

Friday was our last visit to Kennedy Krieger.  We are always met by Miss M., the Research Study Assistant.  She's our guide and chaperone throughout the many-hour long visits.  She schedules our appointments and answers all questions, and waits with us through all sessions.

First stop was Neuropsychology.   Hannah was happy to see the psychologist again (she loves those tests, crazy girl).   She was in there about 75 minutes while I filled out the parent questionnaires--they always seem to have very obvious questions that are targeting the autism population.   When she came out, it was my turn to be interviewed by the psychologist. She is quite nice. She began the interview with me, recording answers as she proceeded.  She started laughing when she got to the question about whether Hannah could/would initiate a conversation with unfamiliar people (answer is: Yes).  Apparently, in the middle of one of Hannah's tests there was a picture of some kids in costumes trick-or-treating.  There was a witch, a clown, a cowboy and a few other costumes. Hannah answered whatever question was asked, but then started a conversation about how the Egyptians would remove the brain from a dead person's head in preparation for mummification. Sometimes Hannah's input to conversations seem total non-sequiturs. But they never are. The psychologist looked closer at the picture, and sure enough, there was a kid in a mummy costume!

All the testing went well. We had a quick lunch before heading over to the medical side of things (a short drive to another building). I was looking forward to hashing ideas out with Dr. Capone. We were in the waiting room for a bit until Miss M. caught up with us. I was surprised and disappointed when Miss M. mentioned that Dr. C was not there. He had a family emergency and had to go to Connecticut that morning. I was unhappy that she hadn't told me two hours earlier--she knew all along that he wasn't there.   Grumph.

I was able to have a conference call with Dr. C, but it wasn't the same as him being there.

So here's the low down: 

He has not received any reports of regression when ending a course of Rivastigmine.

He believes we could proceed safely with using Rivastigmine.

He did not really answer my question asking if he had any patients who have been on a long-term course of Rivastigmine.

Possible long term side effects would not involve neurology, but instead would  involve the same side effects they were watching for in the study:  nausea, vomiting, eventually ulcers would be possible. These side effects have been reduced substantially by slowly weaning in the dosage (similar to what we did in the research trial). Side effects to this point (in the body of research) have been relatively limited.

If we decide to proceed with the medication (the official medication--they cannot reveal that Hannah did or did not receive it), we can add in the ginkgo to her supplements. Ginkgo addresses the excess GABA in the brain, but Rivastigmine works on the acetylcholine channels, so there should be no interaction between the two.

His last comment was "There is no question that uncertainty comes with the territory."

So, that left me with still not having any way to make a decision.  James and I have to pray and ponder.  

It's amazing how quickly the time has passed.  We started this drug trial in January, and now it's over.  We started with it to advance the body of research in the Down syndrome population.  Now we have to figure out if we want to make the decision to make this about benefiting (or, possibly, damaging) Hannah.  Switching from a global perspective to a personal one is going to take some time for me.  We have seen positive changes in Hannah's language and memory--larger gains than we have seen before.  Should we stop now? Should we see where it leads?  We want to provide Hannah with every opportunity to succeed.  Is this an opportunity?  Or a temptation?

If you're new to this thread, I encourage you to start at the beginning.  If you have a child with Down syndrome, this research study may have implications for your child.  Begin here.


Sheena said...

His quote, "There is no question that uncertainty comes with the territory" sums up life that's for sure...

Geez, this is one of those things where your motherly instinct will have to make the call (which is never easy, and you're never really "sure" what will result, or that you can trust your decision.)

I've known Hannah for 2 years now (crazy, right?!) and I've been telling my mom about the research study (mostly because it's fascinating, Hannah's important to me, but also because I noticed improvement in her language, story-telling, logic tracking/connections, physical improvement, etc.) My mom asked me, "But how do you know if that's just Hannah growing up and maturing or if that's the medicine?" Which brings the conversation exactly to where you are.

It does take lots of praying and lots of questions and lots of weighing pros and cons, but I know I haven't met anyone as qualified for the job as YOU! If there is anyone who will get to the bottom of this, it's you :) And if there is anyone who will rise to the occassion, it's Hannah :)

If you ever need a buddy to drink wine and read over research statistics, I'm here!

Anna said...

What a place to be. I am glad you dont have to make the decision right.this.minute. that would just be so stressful. I agree, much prayer and pondering. I am going to re-read over the posts and hope to learn more.

Tara said...

If it were me, I'd first thank the Lord that I know Him and that He promises to give me wisdom when I ask for it. Then, I'd pray like crazy for said wisdom! :)

Becca said...

I have always said the same thing as Sheena - how do we know if it's the growth and maturity taking it's normal course, or if it's the drugs? *sigh* I was hoping there would be more concrete long-term information for you after this. Obviously we have real interest in this, wondering if this is the breakthrough we all hope for. Once again, I'm taken back to Flowers for Algernon (or that next to last episode of House last season...LOL). I wish more could be known.

Wendy said...

See another good reason to have a neon sign!! Don't you think?

Although the decision will not come easy I am very confident that you will come to the right one for your family (yes you are that good :-) While I do think that the people doing the research, tests, etc are a bit more trustworthy and safer than some out there. However it is still bothersome worrying about the "what if's", the "could be's", and those nagging feelings of the "unknowns and possibilities of "oops we didn't know!" Bottom line when it comes to all those nagging thoughts and concerns two things come to mind Ritalin and Cymbalta!! I know I'M SORRY I'm really not helping!!

I did like the idea of 6 on and 6 off (wish I would have done that with E and his Ritalin) that is if there are no current side effects and/or it causing regression/build up. Maybe doing it this way now will shed some light on some of those nagging thoughts, concerns and questions. But in all honesty without knowing ALL the details of EVERYTHING.... my advice is more on gut than knowledge.

I will pray for you guys as well as for peace no matter the decision.

Becky said...

I cannot imagine the decision you are trying to make right now. Research is such a tricky thing. The intent is always to help and advance our ways, but sometimes there are bumps along the way. The future is unknown in research because the research itself is paving a new road...an unknown road...hopefully a good road. Putting your own child out there I bet is scary. You pray those bumps do not happen...especially when it involves your own child. The potential to help out so many is the amazing side of it. I will pray the the Lord guides you to do what is best...best for you...best for Hannah....best for everyone involved...best for the future of anyone that has Down syndrome. He will show you the way. I am sure of that.

Melissa said...

Going from the global perspective to the personal is a hard choice. I too wish there were better answers to if the changes are Hannah, or if they are the medication.

Brandie said...

I can't believe the study is over all ready! Are there any long term studies on this drug, not just in people with DS? Can you find a doctor who regularly prescribes this that would be willing to answer some questions? I like the idea of 6 months on and 6 off. I hope you're able to get some answers tha will help guide your decision.

Anonymous said...

Wow. So what's your gut telling you? Please keep us posted. tell me what you think of long term ginko use too, if you will. Even if it's a repeat. I cannot remember if you ever addressed that specifically.


Created For His Glory said...

You have a beautiful daughter! and God will lead you down the right path ... follow PEACE :)

(mom to 11 here on earth ... 1 with down syndrome... all chosen!)

Kristi said...

Wow! This is tough. All I know of Hannah is what you write. She just seems so sharp and witty! I am always telling my husband about her sophisticated sense of humor :). Praying for you now. Please keep us all posted. I am definitely intrigued for our son is now 11, almost 12.

Anonymous said...

I have known Hannah, through Sheena, for a couple of years now. However, I have only personally known her since she has been taking part in this study. Granted, my exposure to DS is very limited, but Miss Hannah is charming, engaging, intellegent 13 year old I have met in a very long time. She has blossomed in the past 6 months like a springtime garden. I have no idea how much of that is due to the medication, maturity, growth spurt, but it has been beautiful to watch. You have a very difficult decision to make regarding this medication but you have the tools to make it, doctors, family and friends that support you, and a strong spiritual base. You will do fine, but more importanly, Hannah will continue to blow our minds with her abilities and how she overcomes her challenges.