Neuromancer49

Great, now I have to start proof-reading any communications I get from the FDA to make sure it didn't hallucinate a scientific article in the citations. There's going to be so many Vegetative Microscopy proposals.

If you're working on a budget like I was when starting out on my own, I recommend your first purchase to be a bed frame. You can use Ceaigslist / FB marketplace to find some really cheap used options. From there, you can start buying (used) furniture that matches the bed frame. Personally, I needed a nightstand immediately after the bed frame because I wanted to put my glasses somewhere.

Good point, I'm assuming all monitors are as good as mine.

Fair point, but a lot of the article talks about how many studies aren't meeting all four pillars of clinical trial design - that's where my issue comes in, I think reporting that X% of trials do not meet all pillars is a bad metric.

And, not all medications these days are pills or IV infusions - some medications and treatments, which are governed by the FDA, are more invasive and more complicated.

The consent process for clinical trials has a ton of guidance (ICH GCP), but the onus is on the clinical monitors and hospitals to make sure it's done correctly. Many trials now generate supporting documentation in which hospital staff are required to describe the circumstances in which consent was acquired. If the documents are generated, then it's auditable.

Things get a bit hairy when you look at trials in Alzheimer's and other cognitive disorders, because the patient may not be coherent enough to withdraw from the trial. In those cases, a legal guardian is responsible for the decision.

Unfortunately, this was an issue before Trump and will continue to be one afterwards. Assuming there even is an afterwards...

The article brings up some great points, some of which that I, an industry insider, weren't even aware of, especially the historical context surrounding the AIDS epidemic. I'll jump into the thread to critique an issue within the article.

One of the four pillars recommended by the FDA (control groups) are great in theory but can lead to very real problems in practice, specifically within indications that have an unmet treatment need or are exceptionally rare conditions.

If you have a disease that is 99% fatal but has 0 standard of care treatment options, is it ethical to ask a participant to enroll in a clinical trial and potentially not receive the study treatment/be on placebo? Or, what if the trial involves an incredibly invasive procedure like brain surgery - is it ethical for people to do a placebo procedure? Food for thought - and an explanation for why so few trials meet all four criteria proposed by the FDA.

Happy to answer questions about the industry if anyone has them.

To be fair, he did say he "used some open databases for data"

Probably not. To get input from the brain, you need to place a sensor near it. But this device doesn't get inserted into the brain, it sits in the scalp.

There are plenty of non-invasive brain reading technologies though, like EEG and near-infrared spectroscopy. They're just big and bulky with low resolution.

Edit: in the case of prosthetics, it depends on where the disconnect is. If the brain and spinal cord are intact and the issue is in the periphery, yes, you can read the signal far away from the brain (namely the spinal cord) and then work from there.

The motor cortex is located in about the same spot in everyone, to my knowledge - I don't know of any reported exceptions. The pre-central gyrus. Within, motor neurons are organized in specific regions that control specific body parts. Again, I don't know of any reported exceptions - my understanding is everyone's motor cortex has the same organization. It's known as the cortical homunculus. https://en.wikipedia.org/wiki/Cortical_homunculus#Motor_homunculus%3Fwprov=sfla1

So by reading output from a small group of neurons, yes, you could control a prosthetic limb. It's been done a few times, actually! But, you typically need more precision than comes from an EEG electrode, so all the examples I can think of are using invasive electrodes.

In fact, the sensory system of the brain has a very similar organization - along the postcentral gyrus, and the same stereotyped organization within. If you could stimulate the correct region of the sensory cortex, you could create a prosthetic that allows you to feel.

There are some more technical limitations though - there's different types of sensation (e.g., pain, temperature, proprioception (position in space), texture, etc.) that are controlled by different receptors in skin and have different wires connecting to the brain. You'd have to be very careful about what you stimulate. And, any implant that delivers electricity to the brain, with our current technology, has a limited lifespan due to the brain's immune system rejecting the implant (this is the aspect I studied).

Oh, cool, more BCI. I published in this field.

My only concern is how tenable it would be to deploy a bunch of these sensors. EEGs get coverage of the entire brain (surface, not a lot of deep brain activity). Would anyone be willing to wear hundreds, if not thousands, of micro-needles in their scalp?

If it meant controlling a prosthetic, probably. But general commercial devices - probably not.

Scientist here. Microplastics in the body are too ingrained in our bodies for bloodletting to do much of anything. They're even found in fetuses.

The good news (?) is we don't know enough about microplastics to conclusively say they're horrible for our health. The bad news is, I'd bet a lot of money that they are.