Trial By Error: My Exchange of Letters on Amygdala Retraining; That Undead Lightning Process Study

By David Tuller, DrPH

Earlier this week, I wrote to Helena Liira of the Helsinki University Central Hospital about a new trial of “amygdala and insula retraining” for so-called “functional disorders”—fibromyalgia and irritable bowel syndrome along with ME/CFS and long Covid. (I critiqued the trial here.)

In particular, I wondered how the investigators justified use of the phrase “amygdala and insula retraining.” The trial is also an unblinded study relying solely on subjective outcomes—a recipe for bias. Here’s my initial message:

Dear Dr Lira–

I am a public health researcher and journalist with the Center for Global Public Health, part of UC Berkeley’s School of Public Health. I frequently comment on research in the field of ME/CFS and related diseases, now including long Covid. Much of this commentary appears on Virology Blog, a popular science site hosted by Professor Vincent Racaniello, Higgins Professor of Microbiology at Columbia University. (I have cc’d Professor Racaniello here.)

I have recently seen the clinical trial registration for “Amygdala and Insula Retraining (AIR) Program and HUS Internet Therapy Compared to Treatment as Usual in Bodily Stress Syndrome, Fibromyalgia, Long Covid, and Chronic Fatigue Syndrome (ME/CFS).” Yesterday, I posted a Virology Blog commentary in which I criticized the research on a couple of fronts. 

If you would like to send a response to the concerns I have raised, I would be happy to post it on Virology Blog, alongside my critique. If you do so, perhaps you could address these questions:

1) Given the interventions, the study is of course unblinded. However, all the outcomes are subjective. This combination of elements—being unblinded and relying solely on subjective outcomes—is a recipe for generating bias. Participants who know they have received interventions that promise significant benefits are understandably more likely for any number of reasons to report benefits than participants who do not receive the interventions.

Are you concerned about the bias inherent in the study design, and that this issue could create doubt about the accuracy of the results? If not, why not? Did you consider including any biomarkers or objective outcomes of physical function or movement? If not, why not?

2) The study is presented as investigating “amygdala and insula retraining” even though it is not assessing participants’ amygdalae and insulae in any way, much less whether they have been “retrained.” As I assume you understand, the use of this sort of language by so-called “brain rewiring” programs is a marketing strategy designed to enhance their appeal and imply they are grounded in sound science.

Beyond hypothetical musings, can you provide any serious evidence that the intervention in fact involves “amygdala and insula retraining”? (Modest and hard-to-interpret changes in BDNF levels in a small pilot study do not justify use of the phrase; moreover, this trial is not measuring BDNF levels.) 

Are you concerned that giving an intervention an unwarranted scientific-sounding name could lead to bias and unrealistic expectations among participants? Did anyone involved in the design or approval of the study raise concerns that adoption of the phrase “amygdala and brain retraining” was deceptive and perhaps unethical?

As mentioned, I would be happy to post any response you would like to send. Thank you!


David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley


On Wednesday, I received the following from Dr Liira:

Dear Dr Tuller,

Thank you for your email and for your interest in our study. We are not willing to start discussing our ongoing trial, which is of course approved by an ethics committee. Our aim is to help the patients who suffer from these debilitating conditions.

Kindest regards,

Helena Liira


I sent back this message:

Dear Dr Liira–

Thank you for your response. (I apologize for having misspelled your name in my previous message.) I realize of course that the hope is for patients to be helped, and I understand that the trial was approved by an ethics committee.

What I find perplexing—even more than the deficiencies of the study design–is that an ethics committee would approve a trial touting itself as investigating “amygdala and insula retraining.” For researchers to dangle the promise that participants’ amygdalae and insulae will undergo “retraining” is inappropriate. That’s marketing, not science. 

Best—David Tuller


The Undead Lightning Process Trial

The proposed Norwegian trial of the Lightning Process is like the Living Dead. It keeps coming back! Last year, after the study received local approval, a national ethics review panel rejected it for multiple methodological deficiencies. The prolonged and noisy debate over the study was widely covered in the news media.

Last month, after some tweaks, a new version of the trial proposal was again approved at the regional level. Nina Steinkopf, a Norwegian blogger who has covered this issue at length, posted an update on the situation this week.

The science news organization has also published an article about the controversy. The article included background on the first decision from the national ethics committee, or NEM [these passages are Google-translated]:

“The project’s greatest weakness is the conflict of interest that arises because the research fellow has strong business interests in the project giving positive results,” wrote NEM in its decision of 4 June 2021. Based on this conflict of interest and the research fellow’s active role in all stages of the project, the project was not considered justifiable, NEM wrote in the decision. also indicated that the Norwegian ME Association is considering appealing this second regional approval. According to the article, “The ME association cannot see that the applicant has taken into account the objections from NEM, in a way that makes any difference to the study, says Assistant Secretary General Trude Schei in the ME association to”.

9 thoughts on “Trial By Error: My Exchange of Letters on Amygdala Retraining; That Undead Lightning Process Study”

  1. Well given what we know about a shed load of BPS ‘low’ or ‘very low’ quality drivel that also passed ethics committee approval, using that as part of the reason not to engage is very pathetic. But then I guess we all expected an unimpressive response didn’t we?

    Thank you for continuing to cast your beady eye over this junk which pretends to be science and most clearly isn’t.

  2. David, there seems to be Wild West for some of these trials or better called marketing exercises where the system is gamed but it’s interesting to see that in Covid vaccines it has been reported that the major companies are refusing to share their data for independent scrutiny. Given what you have discovered I find myself wondering how do we know when scientific papers are truly genuine and properly peer reviewed.

  3. Geoffrey Hallmann

    To call it marketing is being exceptionally generous. It’s fraud. Pure unadulterated fraud perpetuated by misleading and deceptive terminology without foundation.

    I would target the University and it’s ethics committee.

  4. Science cannot be self-correcting when investigators “are not willing to start discussing our ongoing trial.” I don’t see how anything can be more undermining than that.

  5. What’s more important is asking the ethics committee how they could approve the study. They’ve been questioned in the past & had their prior approval cancelled. I assume they’ve been asked again to explain this 2nd approval but not giving sufficient answers.

  6. I can’t understand it – scientists are usually keen to discuss their research unless it’s top secret.

    I agree with Steven Lubet’s comment above.

  7. I tried an amygdala retraining program. I think my problem is my amygdalae are fast asleep! My pulse has dropped to below 60 and my bp has dropped too. There were a couple of good things that I took away from it but mostly it was terrible. However, I have two friends who swear by it! Am puzzled….

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