Study registration: Amygdala Insula Retraining in the Management of Long COVID Symptoms

rvallee

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Amygdala Insula Retraining in the Management of Long COVID Symptoms
https://clinicaltrials.gov/study/NCT05851846?cond=Long COVID&aggFilters=status:not&rank=3

Brief Summary

The goal of the study is to compare a mind body intervention against usual care in patients with fatigue with long COVID.

Our research questions include
  1. Is the mind body intervention additive to usual care in long COVID
  2. Can the mind body intervention change laboratory markers, heart rate variability and dysautonomia.
Appears to be funded by the Veterans Affairs department. Seems similar to this other study: https://www.s4me.info/threads/in-pr...nctional-disorders-and-long-covid-2022.24444/.

It's framed as a pilot study. A pilot study with 130 participants. What an absurd waste of limited resources.
We aim to conduct a pilot study of AIR to generate preliminary data for a larger, federally funded trial.
 
Recent studies have documented that holistic strategies such as mindfulness, meditation, and amygdala and insula retraining (AIR) have an objective measurable effect on heart rate variability, fatigue, pain, quality of life, depression, anxiety, and gastrointestinal symptoms. The mechanisms proposed include activation of vagus nerve, balancing the autonomic nervous system, reducing stress, and improving immune function.

AIR is based on the principle that viral, bacterial, or environmental insults can sensitize the amygdala, which becomes hypervigilant and unleashes a cascade of hormonal responses that perpetuate a state of neuroinflammation and dysautonomia. AIR de-sensitizes the amygdala, breaking vicious cycles and reducing the maladaptive release of hormones and cytokines.

Our clinical group has already recommended the use of AIR with great anecdotical (sic) response in clinical practice. This strategy is readily available and has no contraindications or risks.
 
I'm not sure why they are bothering with this study. A recent paper suggests that it is all sorted. Whatever your health problem, AIR is the answer.
Neuroplasticity Intervention, Amygdala and Insula Retraining (AIR), Significantly Improves Overall Health ..., 2024, Bratty
Really, they plainly say that they don't even need evidence and they're already using it, so why bother doing research at all? Especially now that they've committed to the conclusion that it works, they certainly won't find that it doesn't. That's the standard model of evidence-based medicine after all. Not to be confused with the standard model of physics, which is based on science and describes reality as it works.

The whole thing about marking your own work has truly reached the absolute peaks of foolishness. It's one thing when you're testing a piece of technology or something like it, but in the case of psychobehavioral stuff it's basically equivalent to rating your own poetry, no one is ever going to find that what they wrote is bad, or they wouldn't have written it. But no one sees any problem with that, for the same reason explained here: they already decided that it's good.

Imagine some cooking game show where the cooks/chefs judge their own creation. And everyone gives themselves a 10 so everyone co-wins. I know fans of cooking TV shows, there would be mass protests, fires would break out at the studios where they film, cats and dogs would engage in mass marriages, fields would become barren from all the salt in the air.

But in medical academia, where it's literally an issue of life and death for millions? All good. In fact point it out to other people who are technically responsible for preventing stuff like this and they will defend it to the bitter end. In fact, fuck you for even saying so, has basically been the response we usually get.
 
There's a poster presentation of this study during the ISLC conference in Amsterdam. The author Ana Palacio claims that Amygdala and Insula Retraining (AIR) Improves Fatigue, Dysautonomia, and Inflammatory Markers in Long COVID.

Unfortunately we're not able to follow the conference itself.

I'm really not sure why it has been approved for ISLC...

 

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The inclusion criteria will be:​
  • Fulfill the definition of PASC
  • Report moderate fatigue as defined by the clinically obtained surveys in the post COVID clinic. The rationale for this inclusion criteria is that 85% of our post COVID patient report fatigue and fatigue is a target outcome can be followed.
  • A probable or confirmed diagnosis of acute COVID-19 infection as per WHO guidelines.
  • Have no evidence of cardiac or pulmonary end organ damage, as per WHO definition. We will define not having end organ damage as a normal ejection fraction on echocardiogram and no pulmonary infiltrates on a non-contrast computed tomography (CT) of the chest during the work-up of the long COVID clinic.


  • Fulfill the definition of PASC
A quick google didn’t bring up anything.
 
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