ProGuardian Research Study.. in, then out...

One of the many things I am thankful for is having a neurologist for Heather that is on top of research and development; be it medications or devices. Several months ago Dr.N talked to us about a device called ProGuardian. This device is supposed to detect seizures while a patient sleeps, and alert you at the start of the seizure. I expressed interest in it, the forgot about it.

Fast forward to last week, we were enrolled in the study. I had very little detail- just a call telling me when and where to have Heather. So I did. Heather was enrolled as patient number 013. Lucky number 13. When I discovered what participant number she was I should have taken that as as sign that this was going to be some what of and issue, should have know there was going to be trouble in paradise.

Andrew and I sat with Heather and the lady from the research department at Dr.N's office as she explained the details of the program, it seemed very simple. We take the device home and use it every night for seven days. There is a caregiver questionnaire notebook with 7 days worth of questions. She explained how easy it is to set up, some of the questions we needed to answer are- does the device detect seizures accurately, what kind of seizures does it pick up, were there seizures missed, is it easy to use. The device was a mystery to us, sitting in a big white box. An exciting mystery.

At the end of the appointment we are handed the device and a urine specimen cup. Heather Ri has to give a sample. - not good- this is never a project that goes well. She is already stating she isn't going to go. I go with her to the restroom, she throws the cup across the room, I knew this was not going to happen! It took several conversations between Dr.N and the research department, but eventually we got the green light to leave without filling the cup.We left in anticipation of opening the box.

Once the day was done and we got home the box was unpacked and instructions were read. Andrew is much more technical minded than I am. I checked out the parts while he read the instruction manual. The set up was quite simple. Proguardian is a wireless device.  Currently the only thing I have is a pulse ox monitor. This is a device with tons of wires everywhere. Proguardian makes no noise unlike the persistent beeping of the pulse ox. The device detects changes in heart rate and movement.


The device picks up the signal by way of a smaller device clipped to a sticker that Heather was to wear on either her chest or back. According to the warnings she couldn't wear it on her chest because she has a VNS implant. So the only option was her back. The back was listed as the least desired placement, but the only option.

                                                         

   At the end of the first night the alarm had gone off several times. I was tired from the constant alarming. I was also upset with the realization at just how many times each night Heather is still seizing..








This what the Proguardian screen looks like. The average length of time between seizures all night long was about like this as well. You can see why I am disappointed and upset.The seizures listed here were all detected by changes in heart rate first. When I came into her room due to the alarm I witnessed Tonic Seizures. Most of the seizures I came into the room for the night of monitoring were Tonic seizures. There were a few that were myoclonic clusters but mostly just Tonic Seizures. It is disheartening and amazing that all this time I really thought her seizures were so much better controlled. We knew she was having atypical absence as well as myoclonics during the day; those have not been that bad though so we have considered them "under control." For a child with Lennox Gastaut Syndrome  "seizure control" is different than what you might consider it to be for the average person with epilepsy. A good day may consist of anywhere from 10 to 50 "minor" seizures.

Feeling defeated the first day of the study I was called by the research department to clarify some information- several times. The final call from them came late in the afternoon, it was bad news. Because Heather did not provide the urine specimen she was being disqualified from the study. Simply put, she had to provide it the first day. As crummy as it is, all of the requirements have to be met. When conducting a study everything has to be in place, all i's dotted and t's crossed. As disspointed as I was, I accept it.

We returned the device, but did get good news, they will be conducting another study with the device soon. This study will be twice as long. Heather will be considered for this study. They certainly need kids that seize and seize- a lot.

There is also another study that will open up in his office. in the coming months I am not at liberty to talk much about whats going on now, but there will be a study for Epidolex in his office. Everyone is very excited. I have read concerns people have about Epidolex v/s Charlottes Web. I have to say I have fewer concerns about Epidolex. In another blog I will talk about why and all the things I have considered. I realize this is a hot topic so it deserves it's very own space, this blog is about ProGuardian, a very cool device that I hope will be available to everyone very soon!