A brain implant changed her life --- AKA --- A Really sad story

A brain implant changed her life. Then it was removed against her will.

This is a story of people, who were benefiting from neuro-implants only to have them removed against their will.
I was going to tuck this into one of my other threads, but I was afraid people would miss it and I am interested what people think about this story.

One of the subjects in these trials was a woman, Rita Leggett, who suffered from Epilepsy.

Leggett received her device during a clinical trial for a brain implant designed to help people with epilepsy. She was diagnosed with severe chronic epilepsy when she was just three years old and routinely had violent seizures.

The unpredictable nature of the episodes meant that she struggled to live a normal life, says Frederic Gilbert, a coauthor of the paper and an ethicist at the University of Tasmania, who regularly interviews her. “She couldn’t go to the supermarket by herself, and she was barely going out of the house,” he says. “It was devastating.”

Leggett was recruited for the clinical trial when she was 49 years old, says Gilbert. A research team in Australia was testing the effectiveness of a device designed to warn people with epilepsy of upcoming seizures. Trial volunteers had four electrodes implanted to monitor their brain activity. Recordings were sent to a device that trained an algorithm to recognize patterns preceding a seizure.

A handheld device would signal how likely a seizure was to occur in the coming minutes or hours—a red light indicated an imminent seizure, while a blue light meant a seizure was very unlikely, for example. Leggett signed up and had the device implanted in 2010

For the first time in her life, she had agency over her seizures—and her life. With the advance warning from the device, she could take medication that prevented the seizures from occurring.
“I felt like I could do anything,” she told Gilbert in interviews undertaken in the years since. “I could drive, I could see people, I was more capable of making good decisions.” Leggett herself, now 62, declined an interview; she is recovering from a recent stroke

Then, for some reason the company, NeuroVista ran out of money ($70m) in 2013.

"She was devastated when, two years later, she was told she had to remove the implant because the company that made it had gone bust. "

The article details how she attempted to keep the device even willing to remortgage her home so she could buy the device...

I wish I could’ve kept it,” Leggett told Gilbert. “I would have done anything to keep it.

Years later, she still cries when she talks about the removal of the device, says Gilbert. “It’s a form of trauma,” he says.

I have never again felt as safe and secure … nor am I the happy, outgoing, confident woman I was,” she told Gilbert in an interview after the device had been removed. “I still get emotional thinking and talking about my device … I’m missing and it’s missing.”

Leggett has also described a deep sense of grief. “They took away that part of me that I could rely on,” she said.

It is a very moving story.
he was not alone in the trial, or other trials like it, where the patients had to remove the device after the trials. Which brings to the point of the article and crux of the discussion.

"If a device can become part of a person, then its removal “represents a form of modification of the self...This is, to our knowledge, the first evidence of this phenomenon”

"This removal could be seen as a violation of human rights, Ienca says. The EU Charter of Fundamental Rights incorporates a right to mental integrity. But this can be interpreted in different ways. Most legal systems seem to see it as a right to access mental-health care rather than specific protections against harm"

"And the right to freedom of thought enshrined in the Universal Declaration of Human Rights is similarly open to interpretation. It was historically put in place to protect freedoms surrounding beliefs, religion, and speech. But that could change, says Ienca. “Rights are not static entities,” he says.

He is among the ethicists and legal scholars investigating the importance of “neuro rights”

NeuroRights Foundation
The Five NeuroRights

“If there is evidence that a brain-computer interface could become part of the self of the human being, then it seems that under no condition besides medical necessity should it be allowed for that BCI to be explanted without the consent of the human user,” says Ienca. “If that is constitutive of the person, then you’re basically removing something constitutive of the person against their will.” Ienca likens it to the forced removal of organs, which is forbidden in international law."

The counter to this concept, comes from Mark Cooke, a neurologist who worked on the trial with Leggett.

“I get a lot of correspondence about this; a lot of people inquiring about how wicked it was,” he says. But Cook feels that outcomes like this are always a possibility in medical trials of drugs and devices. He stresses that it’s important for participants to be fully aware of these possibilities before they take part in such trials."

So is he right, do these companies have a precedent to retain the devices after they have been implanted, or should the patients who benefit from these devices be given such "neurorights"

While I am sure there was/is a pile of legal paperwork these patients have to fill out, does that give these companies a right to make such life changing decisions in cases like these?

How will examples like this effect the BCI industry and neuro rights in the future? How will this impact or be impacted by AI (Neurorights : Do we need new human rights)

I have included some additional links for anyone who wants to learn more
NeuroVista Trial
NeuroVista
Chile: Pioneering the Protection of NeuroRights

i usually use this second post to make a remark about the topic in the OP but I'm just dumbstruck i really dont know what to say other than my heart goes to this woman.
After the devices was removed she had to revert to more trial medications to help her with her epilepsy, which has led to her having a stroke and subsequently bars her from any further similar trials.

What a fukt up world

a reply to: datguy

Perhaps we first need to define the term "benefit" in this context.

Ms. Leggett's device, if I understand correctly, warned her of the likelihood of an impending seizure. On of my relatives also suffers from epileptic seizures, and, as a result had a Vagus Nerve Stimulation (VNS) device implanted to help control the frequency, duration, and intensity of her seizures...with great success.

It is without a doubt that both these souls have benefited from their devices, but I would tend to argue that Ms. Leggett's benefit was more of a psychological nature; her device did not prevent, or even ameliorate, her seizures, it merely advised her as to the likely severity of an impending seizure. Whereas, the VNS device implanted in my relative actually serves to prevent, or at least lessen her seizures.

Not to trivialize but, it is somewhat the difference between having the manufacturer remove (albeit surgically) your Fitbit versus removing your pacemaker.

One is an inconvenience, the other is a potential life-ender.


That said, I do agree that if a company enters into an agreement with an individual, such that the individual's life and/or well-being becomes inexorably tied to the company's product, some form of "continuing-care" provision must be emplaced for the life of the individual.

You make a good point, and thank you for the personal insight.
While I can recognize the difference in the technological capabilities of different types of devices, The result was still life changing.
I cant speak to how such a psychological impact is any more or less beneficial than a physiological one.

In either case the patient now has a new life, a new perspective.
Can you say for sure that the psychological benefits would make an individual more or less happy.

One of the 5 perceived Neurorights is that of personal identity :

"Boundaries must be developed to prohibit technology from disrupting the sense of
self. When Neurotechnology connects individuals with digital networks, it could
blur the line between a person’s consciousness and external technological inputs."

I can see where this ties into the concept of being integrated with an AI but I also think it should apply to such psychological affects.

I am not sure about your relatives implant but how long have they had it, is it part of a similar trial study?
one of the factors for the device in the story being removed was that the battery was set to expire and there is some conversation in the matter on how the hardware implications could effect future trials and impact decisions on neurorights.

originally posted by: datguy
i usually use this second post to make a remark about the topic in the OP but I'm just dumbstruck i really dont know what to say other than my heart goes to this woman.
After the devices was removed she had to revert to more trial medications to help her with her epilepsy, which has led to her having a stroke and subsequently bars her from any further similar trials.

What a fukt up world

An excellent summary (and thanks!) - and yes, truly tragic.

Our technology has the ability to enhance us in so many ways - in reading through your article, I also looked into people who were known as "the first cyborg" (several people claim this title) - often they worked with a group of "rebels" who weren't funded by any particular program and so got to keep their technology.

The danger of such a technology is that "upgrading" it can be very problematic. One of the treatments for Parkinson's (which my husband has) is "DBS" (Deep Brain Stimulation) where electrodes are placed in the brain and impulses sent down the wires to help alleve some of the "twitchyness" (dysknesia) and freezing episodes. But such operations are hard on the patient and removal of a device to put in another one would be risky.

It's difficult to upgrade an implant (think of your 10 or 20 year old computers... that'd be Windows 2000 which was an upgrade from Windows NT (and all the geeks and IT folks with long years of experience are shuddering right now) and there's no real way to upgrade it. There's no support for abandoned technology.

And that could lead to different difficulties.

Still, the situation needs to be resolved in a different manner than the current way.

a reply to: Mantiss2021

An excellent post, and I particularly like the analogy between having a Fitbit removed and a pacemaker removed.

a reply to: datguy

She has had her implant for almost twenty years now, if I remember correctly. I do not know if it was at first part of a trial or not; but once it proved therapeutic, there was no question of maintaining it.

I don't know if I'm fully "on-board" with the idea that psychological benefits have the same, or similar, weight as physiological benefits, at least in terms of quantifiable outcomes: it would seems that withdrawing a psychological "crutch" would not have the same impact on health that withdrawal of a life-sustaining medication/device would have, at least in the short term.

But again, I think we must give due consideration to the definition of the terms we are using.

What, for example, are we to define as the "boundaries" when referring to one's "sense of self"? Something "inside" my body is arguably a part of my "self", but is that true of something I might wear on my body? Something that corrects the effects of disease or injury might be considered necessary to my "self", but can the same be said for something that "merely" (I use the term advisedly) reminds me of my infirmity , however comforting that may be(?), really a part of my "self"?


And let us define what is intended by the now colloquial use of the term "AI", and the fears surrounding it.

I would contend that Artificial Intelligence (AI) is no more dangerous than the (still human) algorithms controlling it. For all the worry and hand-wringing popular culture appears to be indulging in over "the rise of AI", we must remember that the "beast" is no more powerful than we make it. AI has not, and cannot, develop the kind of self-generated desires and motivations that make us humans so dangerous.

AI can be designed to answer our questions faster and, perhaps better than we can, but it is we who are asking the questions; AI's do not care, cannot care, to even formulate the questions. No more than your car gives a fig about the existential choices you've made about your life.


If, however, we ever develop an Artificial Sentience.....

All bets are off.

a reply to: Mantiss2021

I do understand your perspective when it comes the device and its function concerning a psychological crutch. In this case that crutch was her persona, the person she was able to become and viewed herself as. I don't want to say that removing that would be any less detrimental than the physical example of a pacemaker. physical health and mental heath are intricately intertwined.
But in this case she didn't have a choice, it was taken from her. I don't know about anyone else but if I were her I would have put up a fight, people would have to strip from my cold dead hand and I would take the first person that tried with me.
If I personally had to choose between my heart and what I would consider my "self", then I would choose to lose my physical heart and die as the person I am, but I certainly can't speak for everyone.
but I digress

My point being that having some sort of recognition for "NeuroRights", specifically the "right to personal identity" is just as important, IMO, as any bill of rights.

As for AI , there was no intent to insinuate any type overpowering sentience. I only meant to allude to the concept of people using BCI in the future to connect in public spaces and be able to integrate with certain systems. We see many examples of how fast people will find and exploit program weaknesses.
The idea that concepts like the right of "free will", "mental privacy" or "protection from algorithmic bias", are already being discussed within the Neuro rights "community" is somewhat alarming. But no I don't think they are trying to turn us into cyborgs...mainly because the tech hasn't advance that far, YET....

a reply to: Byrd

Surprisingly, while this issue is mentioned in the article as a matter of concern, there is no mention of it from the NRI (Neuro Rights Initiative) in anything I have read. I would think that would be one of the first issues address as its one of the most obvious, at least to me.

a reply to: datguy

I think we are on the same page as far the desire to establish some form of guarantee that any technology or treatment that improves the quality of life should not be subject to non-consenual withdrawal once administered.

This would include Neuro-rights.

a reply to: datguy

As a person who grew up around many family members in the medical field...healthcare is pretty f%*#ed almost everywhere in the world. I say almost because I don't know everything everywhere but I haven't heard of a good system for it yet anywhere. They literally all have major issues...I also don't think that's an accident.

"It was removed against her will"
How? Did they restrain her while she was kicking and fighting to keep it?
Did they have a court order to remove it?

Let's say she had refused to let them operate on her and take it out? Then what? If there no longer is a company to work on the implant if (when) it malfunctions or stops working? Pretty sure that Neurovista had patents on the thing that they wouldn't sell, or couldn't sell, since they were short on money. So why not sell it to another company that could continue the work? Unless it wasn't functioning properly or doing what it was supposed to do in the long run.

All things that aren't mentioned in the articles.
But I do feel bad for the patients who saw their life quality go down again.... like said above, these companies don't care about people, only money

Forgive me, I didn't read the links, the story itself is sad and infuriating enough.

But I have a question:

So the company went bust. The implant worked, but she had to have it removed. So for what? The company went bust. What did they do with it? Destroy it? Sell it?
Why NOT let her keep it if they had no use for it?

Not that I would be shocked, if a company would rather destroy something, than let someone keep something that worked.

Not like it hasn't happened before.

a reply to: Byrd

The danger of such a technology is that "upgrading" it can be very problematic. One of the treatments for Parkinson's (which my husband has) is "DBS" (Deep Brain Stimulation) where electrodes are placed in the brain and impulses sent down the wires to help alleve some of the "twitchyness" (dysknesia) and freezing episodes. But such operations are hard on the patient and removal of a device to put in another one would be risky.

My dad was tested and denied DBS because he had angry outbursts.

a reply to: KindraLabelle2
a reply to: chiefsmom

Sadly you are correct, the closest thing I could find in regards to any of the missing information in the article, is an excerpt buried deep within this article written by the creator of the technology used and the founder of the original company that conducted the trials

www.ncbi.nlm.nih.gov...#

The strategic deal that was going to fund the pivotal study ended up falling through, and the company and technology were acquired by Cyberonics, an early strategic investor. Much of the technology is being used in the next generation Cyberonics LivaNova devices, including multiple subsystems developed for the SAS, as well as my closed-loop IP covering closed-loop VNS systems. I retain 50% ownership in much of the NeuroVista IP, and 100% ownership of this IP in multiple other fields of use, including many applications for closed-loop neuromodulation.

which only proves your statement "companies dont care about people, only money"

This is outrageous! I'm still unsure how to phrase this, but I have to give it out or I explode. The movie Idiocracy was definitely a documentary from the not so distant future.

How on earth did we get to the point where we should/must/have to/expected to accept/respect/support stupid spoiled snotty kids childish behaviour when they identifiy as sparking starfairy unicorn or pink curly cloud flare or whatever they made up that morning, we gotta be careful not to say something that may cause disturbance in their confused little mind (BTW if they feel hurt by criticism then why do they not argue/defend/fight for their opinion?!) BUT THEN zero eff is given to this unfortunate lady's feelings, her quality of life worth nothing when it comes to corporate or governMENTAL interest/agenda. This system is sick and anti human by design.

Society is ready cooked tender. It was told repetitively for decades that the right way to ride a horse is facing backwards, now it can't see it's racing toward the abyss.

a reply to: datguy

I'm sure she signed something, but this seems so cruel and unusual.

It really does amaze me, did she sign her life away for a start? If you buy a car and the firm goes bust they don't come and take your car away and the car company still has the manufacturing rights. If, as stated, it was a clinical trial, why wasn't she being paid for it? She was the one risking life and limb to prove this technology. If that clause was not in the small print I would take them for everything they had.

originally posted by: datguy

Surprisingly, while this issue is mentioned in the article as a matter of concern, there is no mention of it from the NRI (Neuro Rights Initiative) in anything I have read. I would think that would be one of the first issues address as its one of the most obvious, at least to me.

Well, the difference is that I'm a (former) computer geek and I have had to deal with SO many compatibility issues during my work lifetime that this is one of the things I look for first. I've been pretty selective in my technology, so my new laptop works just fine with the 10 year old printers and they work okay with the new 5G network.

But lots of tech won't do that.

And if the company goes bust (as I've experienced with tech), then dealing with problems in your device can start to build up to an insurmountable block. This is a danger with cybernetic implants (or any kind of implant); bodies change and can do things like erode around a device (happens sometimes with artificial joints) and there's a limit to just how often things can be replaced.

Me, I'm trying to stave off a need for cyborg knees right now.

originally posted by: crayzeed
It really does amaze me, did she sign her life away for a start? If you buy a car and the firm goes bust they don't come and take your car away and the car company still has the manufacturing rights.

They don't take away your car, but after 5-10 years you may not be able to get any parts or find any mechanic who can work on it.

It's worse with software. I know several languages that aren't used on computers (and haven't been for awhile.) If you can program in one of these antique languages, you can find jobs at upwards of $40/hour.

Many wheelchair users run into this when their 10 year old wheelchair suddenly breaks after years of daily usage (this happened to a friend.) The only solution is to buy a new (expen$$ive) one (these heavy-duty power wheelchairs cost as much as a new Mitsubishi Outlander.)