Wednesday, December 14, 2011

Clinical Trial Screening Visit

The screening went great! And I was having a seriously fantastic day.

Alyssa, Dr. Rick's nurse, went over the consent form with me. We had a lot of time to chat, because Dr. Rick was running late. Dr. Rick came in and went over the consent form with me again. It was more of a consent packet than a consent form. How can a 25-page document be called a form? Anyway, then Dr. Rick did a neurological exam. The usual stuff.

He said they are very excited to have me in the study. I guess that means I qualified. Alyssa said that it is based on the exam and on my bloodwork--I cannot have hepatitis or HIV. Check and check.

Alyssa took my vitals, drew some blood, and did an EKG.

Michelle, a research assistant, did a "cognitive" exam. I would not really call it that. While it did have one cognitive measure, most of the tasks would not fall under that category. One was fine motor: pegs in holes then out again. How fast can I walk 25 feet (4 seconds!). And some vision tests. The only test I would call cognitive was a recording of a man saying numbers, and I had to add the last two numbers I heard. For example:
-Man: 1......... 8
-Me: 9
-Man: 4
-Me: 12
-Man: 2
-Me: 6
-Man: 7
-Me: Uhhh....
It went on for three minutes. I did fine. I had some slowdowns and forgot the numbers a few times, but I am sure I was well within normal limits.

Then another neurologist, Dr. Andy, came to do a neurological exam. Yes, another one. Two independent assessments are required for the study. Dr. Andy was so nice! Actually, Dr. Rick was, too. And Michelle commented, "He's so sweet." Staff always know what's up, right?

Dr. Andy was much more thorough than Dr. Rick. He just had me do more stuff. And he poked me with a pin. :( But not too hard. He checked sensation more than Dr. Rick did. He checked and rechecked (and re-rechecked) my left leg. And he had me walk laps in the hall with him. I was able to do five laps. The first one was pretty quick, but then I had to slow down. We talked while we walked, and he asked questions like What do you do if you get tired in a store? and Have you considered using a cane for stability? Gee, thanks--I get the hint. I told him that I did buy a cane, but I have not used it yet.

When I got back to the exam room, I was so worn out from walking that I started to cry a little. Sheer exhaustion. But I do not think Dr. Andy knew; he was filling out paperwork.

And that was it. Four hours altogether. I am really excited to get going with the medication, and I will pray that I am in the group that receives the experimental drug, daclizumab. This is the way the study works:

-Group 1: Weekly Avonex injections done at home. These are given into a muscle (intramuscular). Monthly placebo injections done at the MS Center. These are given under the skin (subcutaneous).

-Group 2: Weekly placebo injections done at home, with packaging and materials that look like the Avonex stuff. Monthly daclizumab injections done at the MS Center. I want to be in this group!

The study is double blind, so I will not know which group I am in, and no one at the MS Center will know. I will be a number and initials to the people who know: researchers at the drug company, Biogen. Those researchers will not know my name nor meet me.

Alyssa is looking at getting me in on December 29 or 30 for the next appointment. That will be a long one. Everything we did today, plus a brain MRI and instruction on injecting myself. I will receive the first monthly injection that day, I will do the first weekly injection that day, as well.

Sensory:
-Pins and needles: 1
-Tingles: 0
-Dysesthetic pain: 3
-Paresthesias: 0
-Numbness: 2
-Vision: 3
-Nerve pain: 3

Motor:
-Walking: 1
-Sore muscles: 4, darn walking
-Fine motor: 2
-Weak muscles: 5
-Spasticity: 5, all that walking kicked it up?

Cognitive:
-Language processing: 1
-Memory: 1
-Attention: 1, caught myself zoning out on Dr. Rick a few times, oops
-Confusion: 0

General:
-Fatigue: 3, because Dr. Andy wore me out!
-Balance: 1
-Sleep: 3
-Bladder: 0
-Proprioception: 1

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.