CFS Research Study with Lumbar Punct - Upcoming CFS study with Dr. Baraniuk at Georgetown University

[Never Give Up]

@Never Give Up -if you ask me..that's a lot that they are willing to do. I think it's great. I appreciate this. I was not expecting this. Meaning that they would cover all of that.

After much consideration, here is why I am not going to do it;

I had surgery in January and have not been the same since. I went from working part time, living and going out to being mainly indoors and sometimes bed bound. I do go out and I went to the movies twice last week, but I am so sick and I force myself because I am losing it. All from this surgery. My body can't take on anymore prodding, probing, etc. I had anesthesia, nerve blocks, I have had never ending tests since to now find out what is wrong...etc. I am exhausted.

I couldn't handle the puncture and if something went wrong due to being as ill as I am...I would be angry at myself for having put myself in a line of fire.

I wish I was better because I would be all over it, but at this point in time...I need to stay away from any more hospital type procedures. A lumbar puncture could reveal so much so I am BUMMED.

One good thing; my rheumatologist is sending me for a brain MRI to see if I have white lesions on the brain due to having Sjogrens and CFS and having a total switch in my brain, again, since the surgery.

Anyway, thank you so much for your efforts and you are a trooper for being so proactive! And...a very positive person.

I totally understand. I wasn't expecting you to and hope you didn't feel that I was pressuring you to do so, because that was not my intention. I was just trying to facilitate the process for anyone who might wish to participate and bring research subject challenges to the attention to the research team.

I'm sorry to hear about your setbacks. Hope things turn around soon.

 

[Misfit Toy]

@Never Give Up -No. I didn't think you were pressuring me. I think you are right....I would be a good candidate, being ill for 26 years and becoming more unwell as time went by.

I wish I could do it...maybe I was explaining all of that to myself above!

I hope a few on here do it...let us know if they were accepted and let us know all that happens.

I am still so impressed with how much money they are willing to set people up with, or accommodations, etc. I think it's wonderful. It gives me hope and lets us know there is research going on...we are not being ignored completely. I am very hopeful about this.

 

[Never Give Up]

@Never Give Up -No. I didn't think you were pressuring me. I think you are right....I would be a good candidate, being ill for 26 years and becoming more unwell as time went by.

I wish I could do it...maybe I was explaining all of that to myself above!

I hope a few on here do it...let us know if they were accepted and let us know all that happens.

I am still so impressed with how much money they are willing to set people up with, or accommodations, etc. I think it's wonderful. It gives me hope and lets us know there is research going on...we are not being ignored completely. I am very hopeful about this.

Me too.

 

[SOC]

The Baraniuk Lab has responded:

We understand that there are people who want to participate, but are unable to do that because of financial reasons. We do provide $200 reimbursement for participating in the CFS study, and $100 for participating in the Lumbar Puncture study. If a participant completes both studies, which can be done in the same time frame, then they will be reimbursed for both studies. Plus we also provide up to $300 for travel expenses including plane tickets, taxis, or hotel stays. On top of that we try to schedule people so that they can spend two overnights in our research facility so that they won't need to spend two of their nights in a hotel. If someone is still unable to participate due to finances we talk to them on a case by case basis. We do everything we can to aid in people participating in our studies.

Are you interested in participating in one of our studies? If so, I can send you our informed consent which outlines the study as well as study and travel reimbursement.

Kind Regards,
Madison Keefe

I am very impressed with their understanding of the challenges faced by PWME, and their 2 night lab stay plus financial assistance accommodations. They are working hard to get at the meaningful data. It must be a considerable expense.

Does this help anyone to participate?

Thanks for finding all that out for us, Never Give Up. The $600 would probably cover my airfare, so if I can stay with my daughter in DC when I'm not at the lab, I can probably afford to make the trip. My biggest concern now is whether I'll be capable of traveling alone after a 2-day CPET and a lumbar puncture, even if I give myself a few days afterwards to rest. And, since I live alone, whether the after effects of those tests will incapacitate me for a length of time.

I just wrote to them about schedule and anticipated side effects of the test. Hopefully, it will be manageable.

Oh drat! I forgot to ask if we'll get our individual results from the 2-day CPET, MRI, and lumbar puncture. Getting those for free would be a very big added benefit. Does anybody know if we'll get that info?

 

[Never Give Up]

OK, so I also sent this follow up letter and got the responses that follow:

Hi Madison,

Wow, that is very kind and understanding of you! It must add quite a bit to your study costs.

Actually, I was on one of the forums yesterday and saw discussions about the impossible challenges some faced in trying to participate. I thought I would see if I could help to solve the problem. I am now pondering creating an entity to facilitate the inclusion of the more severely ill in ME/CFS research. Is there anything you think I should know about the administrative challenges researchers face in including the more severely ill?

My child, who has ME/CFS, would not meet your age requirement, plus we live in California, and I'm not too keen on the lumbar puncture. Sorry we can't help in that way.

Best regards.

Dear ,

I shared your email with Dr. Baraniuk, and here is his response. Thank you so much for contacting us. We really appreciate feedback so that we can make our research as efficient and effective as possible.

Kind Regards,
Madison Keefe

Research Assistant

Chronic Pain and Fatigue Research Center
Pre-Clinical Science Bldg Rm: LD3
Georgetown University Medical Center
Phone: 202-687-8231
Fax: 202-687-9886
Chronic Pain and Fatigue Research Center Website


Thanks for your comments. We have too few kids for a big study. If you know of a network of pediatric CFS and parents who would be interested in participating then maybe we can write a targeted grant for this age group.

For the severely ill it is a matter if transportation to Georgetown. The exercise is only up to the point the person wants to stop. Not near maximum. We wheel chair people around so less strain.

LP's are optional for those who are interested.

For severe subjects I would increase budget so they can stay in hotel / other accommodation longer before and after study.

Please send your suggestions. Every subject has made their own personal impact on what and how we do our studies. The protocol is in constant flux to accommodate new suggestions.

Tell your healthy friends to come participate since healthy controls are vital to define "usual" and "illness" differences.

Pass this message along.

Many thanks. Jnbaraniukmd

 

[SOC]

The exercise is only up to the point the person wants to stop. Not near maximum.

They told me this, too. This is great news. I've done the submaximal CPET with no PEM afterwards, but my results were still clearly abnormal.

We wheel chair people around so less strain.

This is a big plus. The last time daughter and I tried to participate in a research study, there was a very long walk from parking to the offices. They also didn't let us eat before the test, then fed us yogurt (yes, dairy). The combination was bad. Daughter went into convulsions as soon as they put in her IV port. We ended up in ER all day instead of participating in the research. Fortunately, it was nothing serious -- the neurologist felt there were simply too many stresses on her body all at the same time.

Researchers who study PWME need to work with our limitations, especially if they want moderate and severe patients to participate. It looks like Baraniak, et al, are willing to work with us instead of force us to work with them regardless of consequences.

 

[SOC]

Darn! I forgot about the fMRI requiring the patient to be in a small narrow tube. Claustrophobia is an exclusionary condition for the MRI study. I have fairly severe claustrophobia. I can control it for brief periods, but not long enough for an fMRI. It's weird because my rational mind has no problem with enclosed situations and I can talk myself calm for a while, but eventually pure, irrational panic takes over and I'm not even thinking anymore, just struggling to get out. It would be interesting from a scientific point of view if it weren't so annoying in a practical sense.

Drat, drat, drat! There goes my participation because I can't afford the travel with the money available for only the one study. I even had my flights picked out.

Who knew it would be so hard to participate in research studies when one is willing to do so and to even take some risks to forward the research? I suppose if I lived near a research center instead of in the back of beyond there would be more opportunities. Sigh....

 

[Sushi]

I have fairly severe claustrophobia. I can control it for brief periods, but not long enough for an fMRI.

Some people take anti-anxiety drugs before that time in the tube. Is that a workable possibility?

 

[SOC]

Some people take anti-anxiety drugs before that time in the tube. Is that a workable possibility?

It's a good question. My claustrophobia is pretty severe. Not just discomfort but full-on irrational screaming panic -- both embarrassing and annoying. I'd hate to go in hoping the anti-anxiety meds would work only to disrupt the whole thing with a literal screaming fit. The weird thing is that once I pass that line where closed eyes, calm thoughts, and deep breathing fail, I don't even know I'm screaming and scrabbling until it's over. I remember on a couple of occasions thinking, "Who's making that ridiculous ruckus?" only to find out a few minutes later it was me.

I've been this way since childhood. The best we've been able to accomplish in dealing with it is to develop sufficient coping skills that I can manage in extreme discomfort for several minutes in a tightly enclosed space. Fortunately, I'm fine with ordinary situations -- closets, cars, airplanes, and so on -- so it rarely impacts my daily life. But closed MRIs or anything else confining me that I can't immediately get out of is out -- unless they knock me out completely , which I believe is not a viable option for an fMRI.

I guess I could try shutting myself in a small space to see if the claustrophobia has improved in the past few years. I think I've got some anti-anxiety meds floating around in my unused meds box.

Seriously though, I might actually try it. So many things have changed with my body over the past few years, maybe that has, too. Ya never know.

 

[SOC]

Good god! fMRIs can take 1-2 hrs?!!! Not a snowball's chance in hell, I'm afraid.

 

[L'engle]

@SOC I have had the same type of fear but mine is about needles. I had to get a measles shot in high school, really not a big deal, but I burst out crying and wailing in front of a huge number of people. So embarrassing!

I'm not considering the research study myself, but I looked up some info about lumbar puncture and how it can be more or less risky depending on needle type and technician training and skill. So those who are on the fence about participating may wish to ask the researchers about whether the thin/atraumatic needles are used, and about the experience level of the technicians. It seems like one of those things where a very skilled injection technician would make a huge difference to the difficulty of the experience.

This is not a fear mongering article so much as it provides a good idea of questions a prospective research subject could ask:
http://www.healthy.net/Health/Article/Spinal_tap/6640

Quotes:

"In a study involving 71 hospitals, only a third inserted the needle correctly. Most physicians preferred to do the procedure with the patient lying down, although it is quicker and easier with the patient sitting (BMJ, 1998; 316: 1709-10)."

"The risk of PDPH seems related to the choice of needle (BMJ, 2000; 321: 986-90), with atraumatic ones causing significantly fewer PDPHs. Yet, most neurologists have never heard of them, and only 2 per cent use them (J Neurosurg, 1986; 64: 253-6)."

"Choice of needle is crucial. Since the 1920s, advocates for atraumatic needles have argued that use of a smaller tapered needle with a blunt tip results in separation, rather than severing, of the dura (a membrane surrounding the CNS) and so fewer complications."


Anyway, the whole subject creeps me out but for those who are braver than me there may be some good questions to ask. The research groups sounds really accommodating and progressive, so hopefully their methods are also of the best and least risky kind.

Good luck to those who participate and thanks from the rest of us!

 

[Sidereal]

@SOC, I had no idea I had claustrophobia until I found myself literally jumping out of an MRI machine a couple of years ago. I was really surprised by my embarrassing reaction. I can't say I'd ever felt anxious in storage closets, elevators etc. They gave me 5 of Valium and tried to get me to go into the tube again but the benzo had zero effect.

(Sorry research team if you're reading this, I don't mean to put off any potential participants. Most people are just fine in an MRI.)

 

[leokitten]

Dr Baraniuk will be giving a talk today in Arlington, VA to discuss his research studies

http://forums.phoenixrising.me/index.php?threads/calendar-of-me-cfs-events.23091/

I will be going to hear what he has to say.

 

[jimells]

Good god! fMRIs can take 1-2 hrs?!!! Not a snowball's chance in hell, I'm afraid.

I wish I could travel to do this research. Lying still is the one thing I am still good at. I have no problems with MRIs as long as I have good earplugs.

I had a spinal tap at the local hospital a few years ago. I had no adverse reactions; After they pumped me up with saline and coffee, I felt better when I left than when I arrived.

If they are interested in having CSF shipped in from the local hospital, I would participate. They could use the $100 to pay for shipping.

 

[SOC]

@SOC, I had no idea I had claustrophobia until I found myself literally jumping out of an MRI machine a couple of years ago. I was really surprised by my embarrassing reaction. I can't say I'd ever felt anxious in storage closets, elevators etc. They gave me 5 of Valium and tried to get me to go into the tube again but the benzo had zero effect.

(Sorry research team if you're reading this, I don't mean to put off any potential participants. Most people are just fine in an MRI.)

I'm glad I'm not the only one! It's surprising and embarrassing, isn't it? What I find so odd is that it's a completely irrational, almost animal, reaction. It's not like I have fearful thoughts. I'm not afraid something bad is going to happen. My body just says, "Nuh-uh, ain't gonna do this, no way, no how" and goes into unthinking panic mode. Go figure.

I will also emphasize that the kind of reaction we have is rare. Most people do fine with an MRI, and most of the remainder manage well with a light sedative. No one should be discouraged from participating in this valuable research from concern about having an fMRI, unless they know for certain they have the unusual reaction we do.

BTW, the info the research team sent me made it clear they are working very hard -- much more than is done routinely for lumbar punctures -- to minimize the possibility of post-lumbar-puncture headaches. I'm impressed with their concern for us and their efforts to minimize the impact of the study on our health.

 

[duncan]

We all have, each of us, our fears. I think there are more fears than "usual" associated with medicine, in part because we are forced to relinquish control to someone else. Or to some technology.

The MRI is a case in point for some. I have gone through a few MRIs. I was fortunate; they have never bothered me. PET scans are very similar to MRIs, except one noticeable difference which did bother me: The dye they gave me for the PET scan was radioactive, so when they went to inject it into my veins, the syringe was encased in a bulky thick lead cylinder. The lead cylinder was not to protect me - it was to protect the person who administered the dye.

Now THAT freaked me out.

 

[Never Give Up]

I wish I could travel to do this research. Lying still is the one thing I am still good at. I have no problems with MRIs as long as I have good earplugs.

I had a spinal tap at the local hospital a few years ago. I had no adverse reactions; After they pumped me up with saline and coffee, I felt better when I left than when I arrived.

If they are interested in having CSF shipped in from the local hospital, I would participate. They could use the $100 to pay for shipping.

Maybe you could contact them and suggest this.

 

[leokitten]

Hi everyone - here's my synopsis of yesterday's lecture by Dr. Baraniuk at Westover Library in Arlington, VA. I just wrote this completely from memory so if I've missed something and remember it later then I will add it to this post.

Dr. Baraniuk presented background and preliminary results of his ongoing studies. Many questions were asked during his slides so he didn't get through everything he wanted to talk about. His current study on ME/CFS patients is the exact same protocol they did and published earlier on GWI. This is on purpose because they want to directly compare cohorts.

The exercise and lumbar studies are actually back-to-back, everything over three days, I'm not 100% sure I got the exact order right:

Day 1 -> Bloodwork -> fMRI -> Exercise -> Day 2 -> Exercise -> fMRI -> Bloodwork -> Day 3 -> Lumbar Puncture (CSF)

They do a submaximal CPET at 70% of your age adjusted maximum heart rate, so (220 - age) * 0.7. Doing a maximal 2-day CPET can be very damaging to some PWME and cause a long crash, so they found that at 70% they still see the same abnormalities while saving people from many PEM symptoms. On a side note he stated that even healthy people do worse on the second day of a 2-day maximal CPET. You can do the exercise study without the lumbar puncture if you want. For these studies he is pragmatic about medication abstinence, what he said is if you agree to do the study then well before the date he tries to very slowly taper down your medication dosages to go as low as you can before the study without having to stop everything.

They have had very good success and improvement over time with post-lumbar puncture migraines, their protocol to minimize this has been fine tuned and they are far below the incidence normally seen in hospitals. They give participants IV fluids, electrolyte drink (e.g. Gatorade), aspirin, and klonopin if needed.

They measure metabolites, glucose, and amino acids in CSF. They do not measure cytokines and he stated two reasons for this, 1) there are a lot of technical challenges, no one currently has a very good method to accurately and reproducibly measure cytokines, although he did mention there is some group in Alberta Canada that is the best in the world at doing this. The other reason is that 2) cytokines are very finicky and their levels go up and down frequently so even if you could accurately measure them the results are difficult to interpret and draw reliable conclusions from.

The use of MRI and CSF is somewhat similar to the study that Drs. Natelson and Shungu are (still currently?) doing and recruiting for in NYC. Dr. Natelson requires you stop medication completely for 7 days prior and they do not do an exercise study.

Dr. Baraniuk's lab have found distinct abnormalities in brain function in PWME and GWI compared to healthy controls and brain function abnormalities in PWME are different then in GWI. Similarly, they've also found distinct abnormalities in CSF metabolites in PWME and GWI and again CSF metabolites are different between PWME and GWI. They do not have any more details on this as they are still finishing data analysis. He did state that they believe they will have a biomarker from the CSF.

They are beginning to link abnormalities they are finding in brain function to symptoms, in particular dysfunction in areas of the brain that control your autonomic nervous system. Their research and studies are still very much in the stage of trying to determine "what" is going on, they have a very long way to go to start asking experimental questions as to "why" things are happening.

He did a short review on the Rituximab studies and growing body of evidence that in many PWME the disease is likely a B-cell mediated autoimmune disease. He described to the group that Fluge and Mella's current theory is that autoantibodies or some other B-cell mediated process is attacking or interfering with vascular endothelium therefore causing dysregulation of fine tune blood flow control and the symptoms of ME/CFS.

Baraniuk said he currently has an alternate theory, that the other mechanism in which blood flow control can become dysregulated is in the centers of the brain and brain stem which control the autonomic nervous system. His belief is that autoantibodies are getting into the brain, even at the low amounts that they do, and these autoantibodies are possibly causing the brain dysfunction that his group has been seeing, e.g. loss of autonomic control and the symptoms of ME/CFS. To me this is somewhat similar to what Jarred Younger proposed.

 

[jimells]

Maybe you could contact them and suggest this.

Yes, I cleaned out all the old spam from my seldom-used email account yesterday so that I can send them a message, and later find their response. I mostly quit email a few years ago when I found the self-imposed obligation to respond was creating anxiety. I somehow survived without email for decades before it became widespread; it's a relief not to have to deal with it.

 

[jimells]

Hi everyone - here's my synopsis of yesterday's lecture by Dr. Baraniuk at Westover Library in Arlington, VA.

Thank you for your very informative summary. I'm curious about who was at the lecture. About how many people were there? Did they seem to be mostly patients or researchers? Any health reporters present?

I hope you didn't wear yourself out and you have a chance to rest today.