– what it’s like to be the willing guinea pig

In my never ending quest to find the answers about fibromyalgia that we all seem to search for once we get our diagnosis, I often tumble down research rabbit holes. I frequently wonder why we don’t know very much about fibro; it’s been around long enough, I feel like we should have more answers by now. But, just as is the case with other diseases and illnesses, getting research done is difficult because in so many places, there just isn’t enough funding.

On one of my trips down the rabbit hole, I happened to search for the term “fibromyalgia research studies” with the intent to find information (hopefully NEW) about studies that have been conducted and read through some of the findings. And on this day, something a bit magical happened for me. I stumbled upon a clinical research trial that is being conducted in my city! It sounded intriguing so I reviewed some of the details and did some research on the doctor and his team conducting the study and decided to fill out the contact form to get more information.

To make a long story short, I ended up applying to be a participant in the study and was accepted. I wanted to write about my experience, because from my perspective, clinical trials in Canada all seem so very mysterious. I know they MUST happen, but there doesn’t seem to be much information about the actual process of being involved in a clinical trial or research study.

I know that being part of a study isn’t for everyone, but maybe taking away some of the mystery around the process and how it went for me might encourage others to get involved as well. My personal motivation behind joining the research trial was that even if I received absolutely no benefit from the treatments during the trial, at very least, I would be contributing to and encouraging more research to be done in the area of fibromyalgia.

There were a lot of steps and moving parts to being a participant in this study, so here’s a quick overview:

• Finding the Study
• Contacting the Study Coordinator and Discussing Pre-Screening Items
• Applying to be a Participant
• Into the Tubes
• The Trial Treatments
• So, I bet you want to know…did it work?
• Overall Experience Rating of Being a Guinea Pig

Finding the Study

I am constantly checking for updates and latest research in the field of Fibromyalgia. I don’t actually come across too many clinical trials, especially near my city. So I was thrilled to find one being done through a local university here.

Once I found the link for the study, I wanted to know more.

JUST, WHY?

I mean it seems like nobody else is doing research for fibro, so I was very interested in their motivation behind the research. What are they trying to find? What is the focus? Do they still believe it’s a mental health issue? What approach are they taking and what are they trying to prove or disprove?

This is important to me because, to participate, I needed the study to jive with my own personal beliefs about fibro–I have my own personal thoughts about what some of the causes are, so it’s important that anything I participate in is not going to go against my belief system. I also find that many study proposals are somewhat vague and non-specific. This one was absolutely not vague at all. They listed 4 main outcomes they were studying along with more than 40 secondary outcomes they were studying. It sounded serious!

The other factor I needed to consider is that many clinical trials, of course, have patents attached to them in the name of the research leader(s) or companies. Again, a question of beliefs: how would I feel if the doctor conducting the study were to profit from discovering a possible successful treatment? Turns out I’m ok with it because I really wanted to be in the study for the greater good and to encourage even more research to be done. As much as I’d like the study to be unbiased, either way, if the research is successful, we all profit. If the doctor profits financially, hopefully it encourages him as well as others to conduct more research. In the end, I did a bunch more research on the specific doctor named in the study and found that he’s been doing plenty of clinical trials in the field of depression and psychiatry. As I did even more research about the proposed treatment, I was honestly a little freaked out.

Commonly known as simply ‘TMS’, transcranial magnetic stimulation sounds wild and was one of the main components of the treatment being studied. My initial reaction was imagining magnetic fields stirring up the muddy parts of my brain. And who wants to mess with their brain? SCARY!! It runs the whole show, what if you wreck it?!?

But actually, TMS has been around for quite a while. It appears to be harmless with little to no bad side effects (ask me later about the crazy dreams!)

Digging around the internet can be very frustrating (hence my rabbit hole reference) but once I found the correct terms to search for, I dug right in and looked at the doctor, the TMS treatments, the proposed medication (who knew a Tuberculosis antibiotic could find other uses so many decades later!) and really ended up feeling comfortable with the level of risk this clinical trial was proposing. And so…..

Contacting the Study Coordinator and Discussing Pre-Screening Items

The next step was as simple as filling out an online contact form. I provided contact information to start the process and received an email about 10 days later (I had actually kind of forgotten I’d even reached out–surprise, surprise – fibro brain strikes again!) We arranged a phone call time so the coordinator could fill me in on some of the study details. She helped me understand the commitment it would take to participate in the study (5 days per week, making a 25 minute drive to the hospital location where the study was being conducted for what would sometimes be only a 5-10 minute visit for treatment or as long as 2.5 hours for MRI’s, etc.) She asked me exclusionary criteria questions. For example, if I were bi-polar or had heart issues (or any of a list of so many other things), I would be disqualified from the study because there is potential for the TMS to cause serious problems with those two particular health issues. I really felt, right from the start, that they were highly concerned about safety.

She conveyed the main objectives of the study and provided a real reason why they were conducting it. In previous studies that used TMS to treat people for depression, they found that MANY symptoms of fibromyalgia overlap depression and had seen a certain amount of success in alleviating pain as one of the unexpected ‘good results’ in those trials and so they were focusing specifically on that aspect this time around. That was comforting and intriguing. Enough so that I decided to take the next step….

Applying to be a Participant

There’s a fair amount of paperwork involved in becoming a participant in a clinical trial. The biggest focus is specifically on informed consent.

Once I agreed to apply to participate, the research coordinator forwarded a long document to me about the details of the study. I booked an appointment for an in-person meeting with the study team. I read the mondo-huge document on a Friday evening, and again on Sunday. It was a lot of information. But it gave me a chance to formulate my questions and on the Monday morning, I showed up for the 1.5 hour appointment to meet the study team.

The first 40 minutes was spent reviewing the document she’d sent me. I told her I’d read it and had a few questions. She was first of all, stunned, saying that she’d never had anyone read the document prior to the meeting. Informed consent is the law here, and also, it was written into the document she’d sent numerous times and several places. How else are you supposed to give informed consent if you don’t read the document? I guess that’s what the meeting in-person is for! To ensure you understand everything! Anyhow, I signed the consent form to participate and then was told there’s one final step – the doctor has the final say on whether a participant is invited into the trial.

Cross my fingers, hope to cry, please don’t let me be crazy in front of the psychiatrist! No, just kidding. Again, as the doctor in charge of the study, he needed to evaluate me for levels of depression and basic mental health questions. And even though I was in the middle of a massive flare, I wasn’t depressed, other than the typical feelings of, “when will this pain ever end?” So, I was accepted into the trial as a study participant (barring any issues that appeared in my blood work).

Into the Tubes

After I left that first meeting, I spent time back and forth with the study coordinator to iron out a schedule that would work for me. Luckily I’m self employed and have a fair bit of freedom with my schedule, but it was important to me to have appointments basically at the same time each day so that I could have some planning room for my business and life as well as some consistency. They were incredibly accommodating. I think that stems from a real desire to remove as many roadblocks as possible and make it as easy as they can for participants.

So many tubes! So little time.

The first day consisted of getting blood work done (again, another safety thing to make sure I didn’t have any conditions that would be contraindicated by taking TMS treatments or possibly getting the antibiotic vs. placebo pill – we wouldn’t want to box my kidneys or anything crazy in the process!) Four tubes of blood and I’ll be off to the races. They have their own lab, right upstairs. I tell ya, the monetary grants that must have made this all possible had to have been huge. Everything is at their fingertips.

The blood work was complete, now onto the pre-study baseline cognitive testing. Oh man, it was a computer game, but made by smart thinking brain doctors.

Brain fog was tough to swim through that day. I did ok on the first few tests, but the last one, I got EVERY SINGLE QUESTION WRONG! How’s that for making me feel good and smart?! Not good! Oh well, thankfully I get a do-over at the end of the four week study and I can only do better next time, not worse!

Also, part of the baseline testing was subjecting me to specific pressure testing where they’d use a measuring device to figure out how much physical pressure they could put on a spot on my back before it became too uncomfortable. They also had me submerge my hand in a cold water bath and time how long I could tolerate it. There were a whole bunch of these types of things checked for the baseline testing. And the last part of the baseline testing was a series of questionnaires which covered grading scales of pain, mobility, mental health and things like that. They were pretty quick and easy to complete on the computer at home.

The next day was another trip in a tube. An hour in the MRI (a ‘free’ MRI thanks to monetary grant funding for research–who doesn’t wanna see what’s in their brain!?) Again, just a short trip through the hospital, another thing right at their fingertips. (I just found out from a friend who paid for her own private MRI recently to get herself ahead of the queue paid over $700!)

If you’ve never been in an MRI, the tube is small, like being held in a close hug around your shoulders. And it’s slow. And it’s noisy. Except also it’s not.

They gave me ear plugs and also put these giant foam blocks on either side of my head (mainly to keep me from moving my head) that really insulated me from the sound. With all that insulation, I actually felt it wasn’t any more noisy than being underwater at the swimming pool. Everything had that kind of far away, dull echo sound quality to it. My head and the blocks were strapped down into place and away I went into the MRI so they could take 1 millimeter pictures of my brain from the front to back, side to side and top to bottom. I was in there for about an hour and did my best to meditate. They frequently checked in to make sure I was doing ok and gave me updates on how long each “next segment” would take. Not like it meant anything. When you’re trapped in a tube with nothing but your thoughts, time becomes a bit meaningless.

The Trial Treatments

With my brain images all mapped and loaded up to their computer, they could now proceed with the following protocol:

Monday to Friday I was instructed to take the study medication between 60 and 90 minutes prior to my TMS appointment. And on each of those five days of the week I would attend TMS treatment.

All this technology helped to map out where my head was in the physical space in front of the camera. The camera is a dual lens device that has a long neck and if you can remember the character “WALL-e” from the movie, you’ll have kind of an idea what that looks like. All these traced marks were overlaid on top of the MRI images they had loaded into the computer and helped them to aim the magnetic field to the very precise spot in my brain called the dorsal lateral prefrontal cortex. (Image 1 above.)

In order to figure out how much strength needed to be behind the stimulation, the first time they pointed the magnetic field to a spot in the brain which controls movement in the dominant hand (I think it was the motor cortex, but can’t recall for sure.) Once they had applied enough of the TMS to that spot, it made my thumb twitch and that’s how they knew the magic number they wanted for the treatment site. They were aiming for 80% of what it took to make my thumb move. My magic number was 33.

TMS is not what I would call painful. It’s more in the category of annoying, like your little brother flicking you in the forehead with his finger as hard as he could. Repeatedly. However, the first time, it’s kind of surprising. And when I’m in the middle of a flare up, I’m not too tolerant of being annoyed or surprised! They were sensitive to this and were flexible with the magic number, especially for the first week. There’s always a “test shot” of stimulation to start every appointment and my discomfort was always considered at each session.

At the halfway point of the study, I was given more questionnaires to fill out. They were, I think, the very same as the ones I completed at the baseline testing, but maybe in a different order. At any rate, I was quite pleasantly surprised to find that I was feeling better. Honestly, two weeks prior when I walked into the study, I was in a pretty massive flare, so anything probably would have felt better after the first week. I also had a meeting with the doctor to evaluate my mental health and I thanked him for conducting the study. I told him I didn’t think there were enough studies happening in the field of pain relief for fibromyalgia and he agreed, stating he was doing it for selfish reasons. (I didn’t ask, but I inferred that he was a sufferer too.)

In my passing conversations with the doctor at one of my treatments, we were discussing the TMS machine and how fascinating it was. It has accuracy within just a couple of millimeters. It was explained to me that there are two coils inside of the handheld device which create a cone-shaped magnetic field which extends out of the device about 3-4 centimeters and this is what is the key to being able to “pin the tail” on the dorsal lateral prefrontal cortex with such accuracy. And those coils are pricey! Something like ten thousand dollars per coil. And, they “expire”. They’re only good for something like 5,000 ‘zaps’ and then they need to be replaced. (Please don’t fact check me on these numbers. I’m really generalizing– but not exaggerating – because I can’t clearly remember the exact numbers. I just remember thinking, ‘holy crap, that’s a lot of dollars per zap and here I am getting about 25 or so zaps per treatment.’)

From the outside looking in, this is an incredibly expensive venture to perform this trial. So, two things: I now understand why it’s so hard to get research done and also, I genuinely hope it’s successful and worthwhile.

I’m writing this on the second-last treatment day. I have one more treatment, more of the questionnaires, blood work and cognitive testing ‘computer games’ left to complete tomorrow.

On Monday, I’ll head in for my post treatment MRI (let’s just see if there were any magical changes to my brain!!) and sensory testing again (hand in the cold water sounds great this week in this weather!) And then after one month, I have a follow up with the doctor to see if it “worked.”

So, I bet you want to know…did it work?

Well, I think time will tell. I don’t think it’s ‘cured’ my fibromyalgia. But, I do FEEL DIFFERENT. My pain is not as intense. I don’t have pain in as many places all at once as I did four weeks ago when this all began. I did have another major flare during week three of treatment, but it was VERY different than my usual flares. Instead of hurting in every muscle and every joint, my flare seemed to be limited to my lower back, hips and tailbone area. And that was it. It was an awful score of 15 on the pain scale out of ten and I needed a cane to get around for a few days, but it was different from my usual flare ups. Now, I generally feel like I can walk again without crippling knee pain on a daily basis. It’s changed and is now only sporadic. I might actually be able to start doing deep knee bend exercises again if this keeps up.

So, only time will tell. I will do the one month follow up and see if the changes have stuck with me. And then, with any luck, I can go to my doctor and try getting off the latest pain medication. But, I’ve been here before where something new and novel tricks out my brain for a while and the pain is better for a while. I don’t want to sound like a pessimist, but I’ve been here before. And the pain has faithfully returned to me like some nagging old witch. So I’ll wait and see.

Overall Experience Rating of Being a Guinea Pig

It’s not as fun as winning a big prize after playing a game show or anything. It was interesting, if you’re interested in seeing inside your brain and finding out how the brain works.

On the scientific interest front, I give this clinical trial a 10/10.
The doctor and treatment team running the clinical trial also get a 10/10. They were amazing, caring, kind people with great humour and empathy.

Grading for Side Effects: minor headaches (I think were weather related) and periodic heartburn after taking the study pill; all liveable. Dreams, crazy, crazy dreams. I’m an insomniac, for as far back as I can remember and I rarely, if ever, have dreams. But dreams I certainly did have during the clinical trial. I’d kind of forgotten how fun and nice it was to have dreams. So, in my case, that was a plus. I’m not sure if it can be attributed to the TMS or not, but the ladies performing most of the TMS treatments for me said that anecdotally it had been reported by several participants so far. I give side effects an 8/10.

Grading for success level of the treatment: I’ll give it an 8/10 here for now and maybe update it later. I feel a difference and I will give the trial the benefit of the doubt and attribute that feeling of less pain (not no pain, but definitely less volume & intensity) to the TMS and the pill, whether it’s placebo or real.

Final rating: I would participate in another clinical trial if it was congruent with my beliefs and posed what I considered to be minimal risk (afterall, some days, in the middle of a flare up, anything is better than nothing, so risk seems easier to tolerate.) Overall it was a pretty positive experience. I give this study a 9/10 overall as my final rating

Area	Grade
Scientific Interest	10/10
Doctor & Treatment Team	10/10
Side Effects	8/10
Treatment Effectiveness	8/10
Overall Grade	9/10