Very few things are proved definitively in science. You test a hypothesis with statistics, which always carries a margin of error. Usually, it’s 5% - the probability that your data randomly supports your hypothesis, even though there’s no true relationship.
Personally, I prefer when journalists coach their language to avoid overstating the truth.
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.
You’ll never believe how it effects sales tax (if you’re not buying from a second hand store).
Standard? Not really. But there’s a tutorial here: https://github.com/miykael/3dprintyourbrain
Happy to answer some questions if you have issues
Interesting question. It depends. I linked Ev Fedorenko’s Interesting Brain Project at MIT up above, they’re doing a deep dive into questions like those.
Broadly speaking, if you’re born with these anatomical anomalies, you’ll be more or less normal. The article mentions the person in question had an IQ of 70, so that’s lower than normal, but not intellectually impaired.
But acquired Brain damage almost always leads to impediments. Strokes and repeated concussions, physical injury, etc.
The brain is “plastic” when you’re young, we like to say. That is, it’s pliable and can mold into whatever shape it needs to in order to adapt to your environment. That plasticity disappears once you get older. It’s how kids can learn language effortlessly - when you’re born, you have the most neurons and synapses you’ll ever have in your life. You’ll keep the same neurons (unless you have a degenerative disorder or kill them with drugs), make new synapses as you learn, but broadly speaking as you grow up you prune synapses that aren’t helpful.
This is also why kids can undergo massive resection surgeries (or in the olden days, severing of the corpus callosum) and grow up more or less normal.
In the US getting an MRI for “no reason” can be very expensive. Probably wouldn’t have been covered by insurance.
Ev Fedorenko has done some of the best research in brain science, in my opinion. There’s no better rabbit hole than her research!
Eh, college is hard and so was his sport. Sure, it’s not an exhaustive battery of testing but I’m confident to say he’s a normal dude.
It proved there were benefits, read the article.