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FDA reportedly denied Neuralink’s request to begin human trials of its brain implant – Engadget

  1. FDA reportedly denied Neuralink’s request to begin human trials of its brain implant Engadget
  2. U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks CNBC
  3. Musk’s bid to start Neuralink human trials denied by FDA in 2022, report says Ars Technica
  4. Elon Musk’s Plans to Test Neuralink in Humans Reportedly Squashed by FDA Gizmodo
  5. No, Elon Musk can’t put chips into people’s brains: Regulators rejected Neuralink’s device due to safety risks, report says Fortune
  6. View Full Coverage on Google News

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First implant to treat depression is REVEALED: New brain chip set to rival Elon Musk’s Nueralink

While Elon Musk’s Neuralink expects to begin human trials in six months, a neurotech company unveiled a device that treats depression and is now in the skull of the first patient.

Inner Cosmos’s ‘digital pill’ includes two parts: An electrode that sits under the skin of the scalp and the ‘prescription pod’ that snaps onto the users’ hair to power the device.

The implant sends tiny electrical pulses to the brain region affected by depression – the left dorsolateral prefrontal cortex – once daily for 15 minutes.

And the external device does not need to be on the head when treatment is not being administered.

The trial patient from St Louise, Missouri, is scheduled to test Inner Cosmos innovation for one year, and the company has another human trial set to start next month.

Inner Cosmos has unveiled the first brain implant to treat depression. The digital pill is the smallest and least invasive technology to date – the implant is about the size of a penny

Implants to treat all alignments of the brain are making waves in the industry, as several companies are racing to get theirs to market first.

Musk’s Neuralink recently conducted a product demonstration that showed its chip in a monkey’s brain, allowing it to control a keyboard on a screen to type out complete sentences.

Synchron began human trials of its brain implant in July, which lets the wearer control a computer using thought alone.

The firm’s Stentrode brain implant, about the size of a paperclip, will be implanted in six New York and Pittsburgh patients with severe paralysis. 

Stentrode will let patients control digital devices just by thinking and give them the ability to perform daily tasks, including texting, emailing and shopping online. 

Research facilities are also developing brain chips.

Southmead Hospital in Bristol is believed to be the first in the world to implant a device to reverse symptoms of Parkinson’s.

However, Inner cosmos digital pill is the smallest and least invasive technology to date – the implant is about the size of a penny.

And the company likens the external pod to charging an Apple Watch. 

The surgery for the implant takes 30 minutes in an outpatient facility. 

Inner Cosmos was founded by entrepreneur Meron Gribetz, who was diagnosed with attention deficit disorder as a child.

‘Our mission is to create a world that restores humanity’s cognitive power by rebalancing the human mind,’ said Gribetz.

‘The world is in a state of severe disorder, leading to a disordered cognition 

‘The effects are being felt by millions, leading to surging levels of depression. 

‘We believe our approach can allay the lives of those suffering from depression, and eventually scale to other cognitive disorders.’

The goal of Inner Cosmos is to move away from prescription drugs and toward a more ‘effective treatment.’ 

‘Depression, attention and anxiety, which we treat. Just to underscore this point, there’s 140 million Americans every year that use attention or depression drugs, that’s more users than have iPhones,’  Gribetz said in a 2022 presentation.

Inner Cosmos’s ‘digital pill’ includes two parts: An electrode that sits under the skin of the scalp and the ‘prescription pod’ that snaps onto the users’ hair to power the device

The implant sends pulses to the brain region affected by depression – the left dorsolateral prefrontal cortex – once a day for 15 minutes. And the external device does not need to be on the head when treatment is not being administered

Inner Cosmos digital pill is powered by a smartphone app, which also displays mood and depression graphs that can be shared with a physician. 

Gribetz said this is the first time doctors will have access to this type of data, ‘saving the healthcare industry billions for misdiagnosis of severe suicidal depression,’ he said.

‘[The implant] is 10 times smaller than anything else that you’ve heard of globally, on the brain chips BCI [brain computer interface] market, and we’re really excited,’ said Gribetz. ‘It took us six years to build this thing.’

If you enjoyed this article… 

Brain implant helps reverse symptoms of Parkinson’s in first patient to receive the treatment as part of medical trial 

‘Mind-reading’ brain implant allows California man, 36, to ‘talk’ again after he was paralyzed from the neck down at 20 

Elon Musk’s Neuralink rival Synchron begins human trials of its BRAIN IMPLANT that lets the wearer control a computer using thought alone 

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Scientists Repair Pig Erections With New Kind of Penis Implant

Photo: Gorb Andrii (Shutterstock)

Scientists in China believe they may have found a better way to fix an injured penis. In research published this week, a synthetic material developed by the team was able to restore normal erectile function when implanted in pigs. The material may offer important advantages over existing methods, and it may even have applications for other kinds of tissue repair.

In a penis, the tunica albuginea is the protective, elastic layer surrounding the erectile tissue that pumps blood to the organ. It plays a vital role in maintaining an erection, and it’s often one of the parts of the penis damaged by certain conditions or injuries, including a broken penis. And while there are surgical treatments that can repair a damaged urethra, current procedures tend to be less effective at restoring a functional tunica albuginea. Patches attached to the tunica albuginea, largely made of tissue from somewhere else in the body, can be rejected by the immune system, for instance. And these patches simply don’t resemble the natural tunica albuginea on a microscopic level, meaning that they usually can’t restore normal erectile function.

Scientists from the South China University of Technology decided to try a different approach to repairing these kinds of injuries. They aimed to create a safe and synthetic material with similar physical properties as the tunica albuginea, which can bend and twist when the penis isn’t erect and then easily become rigid during an erection. The team’s artificial tunica albuginea is made of hydrogels arranged in a stacked fiber structure, similar to the natural version.

A diagram showing how the artificial material can mimic the process involved in a natural erection.
Graphic: Matter/Chai et al

“Our research is based on a simple scientific hypothesis: by simulating the microstructure of natural tissues, we can obtain artificial materials with properties similar to those of the tissues,” senior author Xuetao Shi told Gizmodo in an email.

In animal experiments involving pigs with a damaged tunica albuginea, the material appeared to allow their erect penises to expand as rigidly as in normal pigs (to make the penises erect on demand, a saline injection was used). And though the material didn’t repair the tissue surrounding it, it didn’t appear to cause any added scarring a month later.

“Our study demonstrates that [the artificial tunica albuginea] has great promise for penile injury repair,” the authors wrote in their paper, published Wednesday in Matter.

Encouraging as these results are, this technology is still only in its early stages, Shi notes. There’s a lot more research to be done before it could be widely tested in humans. Among other things, they have to confirm the material’s long-term effectiveness and safety, meaning it could survive unobtrusively in the body for at least three to five years. There are also probably improvements that could be made in how it’s implanted onto the penis (right now, the team is using a simple suture). And even if this material works as intended, it’s only one piece of the puzzle, since injured penises are often damaged in several ways, not just along the tunica albuginea.

The team is working on refining their technology and on better ways to repair the penis as a whole, including the treatment of permanent nerve damage. And team’s basic approach could possibly be used for other tissues, such as those found in the bladder and heart, though the material would likely require adjustments depending on the tissue it’s meant to repair, Shi noted.

“In the future, we hope to systematically study the male reproductive system with the aim of achieving functional simulation and in vitro reconstruction at the organ level of the penis and testes,” Shi said. “On the other hand, we are also working with clinicians to enable early clinical application of artificial TA, which we think is very likely to happen.”

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Implant may reduce OCD symptoms with electrical pulses

“Deep brain stimulation,” or DBS, can offer significant relief to as many as two-thirds of patients with severe obsessive-compulsive disorder, a new study found. Photo by Raman Oza/Pixabay

When traditional treatments fail to help patients with severe obsessive-compulsive disorder (OCD), an implant that zaps the brain with electrical pulses just might, a new research review shows.

It found that the remedy — known as “deep brain stimulation,” or DBS — can offer significant relief to as many as two-thirds of such patients. On average, it can reduce OCD-triggered symptoms by nearly half, the review found.

“[OCD involves] intrusive and bothersome thoughts that the individual cannot silence, and compulsions that are repetitive, ritualistic behaviors performed to reduce the anxiety produced by the compulsions,” said study author Dr. Sameer Sheth. He is an associate professor of neurosurgery at Baylor College of Medicine in Houston.

An estimated 3% of the global population is thought to be affected. For those with severe OCD that is uncontrolled, the symptoms can be “all-consuming,” Sheth said. Examples of OCD include repeated handwashing, ordering and arranging, repeating words in one’s head, and checking and double-checking.

“They can prevent the person from being able to perform other necessary activities of life, and therefore be extremely disabling,” Sheth said. “Some people cannot leave their room or home because of the cleaning rituals that would be necessary to re-enter, or cannot interact with others because of incessant taboo thoughts.”

The good news is that a combination of behavioral therapy and standard antidepressants — such as serotonin reuptake inhibitors (SRIs) — help many individuals.

The bad news: “About 10% to 20% do not respond” to those treatments, Sheth said.

Enter DBS, a pacemaker-like system, for the brain.

“Like a pacemaker, it consists of a stimulator typically implanted under the skin in the upper chest, and connected to a wire (electrode),” he said. “The electrode is implanted in specific regions in the brain,” including those involved in decision making and balancing emotions.

The aim is that by restoring activity in these areas to a more balanced state, DBS settles the symptoms of OCD.

But does it work?

To find out, Sheth’s team reviewed the findings of 31 studies conducted between 2005 and 2021.

Collectively, the studies included 345 adult OCD patients, at an average age of 40. All had struggled with a severe-to-extreme form of OCD that had not responded to standard treatments.

On average, participants had spent nearly 25 years battling crippling OCD symptoms. Many also suffered from depression, anxiety and/or personality disorders.

The review showed that after an average treatment period of about two years, DBS had yielded notable symptom improvements in two-thirds of the patients. On average, symptoms eased 47%, the researchers reported.

Significant depression relief was also attributed to DBS treatment. The studies found it eliminated the issue in half of patients for whom it had been a concern.

The studies found downsides to DBS therapy, as well.

About one in five patients experienced at least one serious side effect of DBS, the review found. These can include an increased risk for seizures, suicide attempts, stroke, and new OCD symptoms linked to DBS itself.

Still, Sheth stressed that the upside is hard to ignore, noting that the level of symptom relief linked to DBS “usually allows people to function again,” at school, at work and in relationships.

“Patients almost never get worse,” he added, “so there is actually little risk of DBS for appropriately selected patients.”

Sheth’s takeaway: “DBS for OCD is an effective and safe treatment, as we have now shown with rigorous analysis of hundreds of patients across several countries.” With time, DBS is likely to become even more effective, as “consistency in improvement will increase,” he added.

Two experts who were not involved with the study largely agree.

“Since the [DBS] electrodes are implanted in the brain regions contributing to OCD, it is not a surprise that it works,” said Dr. Gopalkumar Rakesh, an assistant professor of psychiatry at the University of Kentucky College of Medicine, in Lexington.

What’s needed now, Rakesh said, is the adoption of a “precision-medicine approach” to DBS use, so that doctors and scientists are better at predicting what makes a person with OCD respond well to it.

Dr. Jeffrey Borenstein, president and CEO of the Brain & Behavior Research Foundation in New York City, echoed that thought.

“Even though it’s not a brand-new therapy, DBS really is in the more-research-needed stage of development,” Borenstein said. “So I would say that the results of this study point to the need for even more research, in order to determine which patients would be more likely to benefit, and to really fine-tune that treatment so as to have the greatest benefit.”

The research review was published online Tuesday in the Journal of Neurology, Neurosurgery & Psychiatry.

More information

There’s more about deep brain stimulation for OCD at Mount Sinai.

Copyright © 2022 HealthDay. All rights reserved.

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An Implant Made From Pig Skin Restored 19 People’s Eyesight in Recent Trial

The implant developed by scientists from Linköping University.
Photo: Thor Balkhed/Linköping University

A team of scientists say they’ve found a new way to help people with damaged corneas: bioengineered implants created from pig skin. In findings from a small clinical trial published this month, the implants were shown to restore people’s eyesight for up to two years, including in those who were legally blind. Should it continue to show promise, the technology may one day provide a mass-produced alternative to donated human corneas for people with these conditions.

The cornea is the transparent outer covering of the eye. In addition to protecting the rest of the eye, it helps us see by focusing the light that passes through it. Corneas can heal from mild abrasions easily enough, but more serious injury and certain diseases can leave behind permanently damaged corneas that start to impair our eyesight. Around 4 million people are thought to suffer from vision-related problems caused by injured corneas, according to the World Health Organization, and it’s one of the leading causes of blindness.

For those with severely damaged corneas, the only truly effective treatment is a transplant of a healthy cornea, also known as a corneal graft. Unfortunately, like many organs, human corneas have to be used very soon after they’ve been donated, and they’re often in short supply, especially for people living in poorer countries. That scarcity has fueled efforts by researchers to find other methods to replace or support damaged corneas. One such approach is the implant created by researchers from Linköping University (LiU) in Sweden, who have also founded the company LinkoCare Life Sciences AB to further develop it.

In their research, published last week in Nature Biotechnology, the team gave their implant to 20 patients from India and Iran with advanced keratoconus, a condition where the cornea progressively thins out. Nineteen of 20 patients experienced substantial improvements to their eyesight afterward, with all 14 people who were legally blind no longer meeting that threshold. The patients who needed further corrective treatment were also now able to tolerate contact lenses again. And these gains remained stable two years after, while no adverse events were reported.

“The results show that it is possible to develop a biomaterial that meets all the criteria for being used as human implants, which can be mass-produced and stored up to two years and thereby reach even more people with vision problems,” said study author Mehrdad Rafat, a professor at LiU’s Department of Biomedical Engineering and CEO of LinkoCare, in a statement from the university.

There are existing artificial corneas in use, as well as similar treatments in development. But the researchers say their implant should have some key advantages over these options. Many of these treatments still rely on donated corneas to reduce the risk of rejection by the body, while the team’s implant instead uses relatively cheap biosynthetic material derived from purified pig skin. The material is then used to create a thin but durable layer of mostly collagen, the same basic ingredient of the cornea. In the current study, the patients were only given eight weeks of transplant drugs to ensure acceptance by the body, as opposed to the year or more of medication typically given to those with cornea grafts, and no signs of rejection were reported.

They’ve also developed a less invasive method of surgery to insert their implant, one that doesn’t need to remove the original cornea, which should reduce the risk of complications and allow for broader use in places with fewer resources. And other research of theirs suggests that the materials in the implant should remain stable for at least eight years, if not longer.

“We’ve made significant efforts to ensure that our invention will be widely available and affordable by all and not just by the wealthy. That’s why this technology can be used in all parts of the world,” Rafat said.

Of course, these findings are still very small in scope. It will take successful results seen in many more patients before any country would think to approve this treatment. To that end, the researchers are planning larger clinical trials of their implant, and they may broaden their work to see if the treatment can work for other cornea-related conditions.

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Scientists develop implant that reduces pain without drugs

A team of researchers led by Northwestern University has developed a dissolvable implant that rapidly relieves pain without the use of drugs, according to a study published in Science. 

The biocompatible implant is controlled by an external pump that allows the patient to activate it at the onset of pain and control its intensity. The implant would not require surgery to remove since it is water-soluble and will simply dissolve.

“The technology reported here exploits mechanisms that have some similarities to those that cause your fingers to feel numb when cold. Our implant allows that effect to be produced in a programmable way, directly and locally to targeted nerves, even those deep within surrounding soft tissues,” Rogers said.

The implant is 5 millimeters long at its widest point. It works by softly wrapping around a single nerve, while another end is attached to the control pump outside of the skin. The implant evaporates a liquid coolant in the targeted area, which numbs the nerve and blocks pain signals to the brain.

Evaporation is achieved via tiny microfluidic channels contained in the implant, one channel contains the coolant perfluoropentane — a clinically approved ultrasound contrast agent which is also used for pressurized inhalers, and another channel contains dry nitrogen, an inert gas. When the coolant and gas flow into the same chamber evaporation instantly occurs, and an integrated sensor monitors the nerve to make sure its temperature does not drop to a level that could cause tissue damage.

The implant is controlled by an external pump that allows the patient to activate it at the onset of pain.
Northwestern

“Excessive cooling can damage the nerve and the fragile tissues around it,” Rogers said. “The duration and temperature of the cooling must therefore be controlled precisely. “By monitoring the temperature at the nerve, the flow rates can be adjusted automatically to set a point that blocks pain in a reversible, safe manner.”

“As you cool down a nerve, the signals that travel through the nerve become slower and slower – eventually stopping completely,” said study co-author Dr. Matthew MacEwan of Washington University School of Medicine in St Louis.

Researchers believe it will be a safe alternative to opioids.
Northwestern

“We are specifically targeting peripheral nerves, which connect your brain and your spinal cord to the rest of your body. These are the nerves that communicate sensory stimuli, including pain.” Dr. MacEwan said, “by delivering a cooling effect to just one or two targeted nerves, we can effectively modulate pain signals in one specific region of the body.”

The researchers believe their device will be a safe alternative to opioids and other highly addictive medications. They foresee its greatest benefits going towards people who undergo routine surgeries and amputees who require post-surgery medications to manage pain.

“Although opioids are extremely effective, they also are extremely addictive,” Northwestern’s John A. Rogers, who led the device’s development told Reuters. “As engineers, we are motivated by the idea of treating pain without drugs.”

Rogers tells Smithsonian that further studies are necessary before the implant can be tested on humans, it was previously tested on rats. He says more must be learned about the human body to make the device more compatible and prevent possible side effects like overcooling.

”After you stop the cooling, how long does it take the nerve to kind of recover so you can restart the cooling?” he says. “Those are the kinds of studies that I think are the most important ones to conduct before using a device with humans.”

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Scientists develop first-of-its-kind implant that relieves pain without drugs

Researchers at the Northwestern University have developed a device that sounds straight out of science fiction: a small, soft, flexible first-of-its-kind implant that relieves pain on demand, without the use of drugs and dissolves.

The biocompatible, water-soluble device could provide a much-needed alternative to opioids and other highly addictive medications. As per the researchers, the device could be highly valuable for patients who undergo routine surgeries or amputations that most often need post-operative medications. Surgeons could implant the device during the procedure to ‘manage’ the patient’s post-operative pain.

The study published in the July 1 issue of the journal Science, describes the device’s design and demonstrates its efficacy in an animal model.

The devices employs a simple mechanism

“Although opioids are extremely effective, they also are extremely addictive,” said Northwestern’s John A. Rogers, who led the device’s development, in a press release. “As engineers, we are motivated by the idea of treating pain without drugs — in ways that can be turned on and off instantly, with user control over the intensity of relief. The technology reported here exploits the mechanism that causes your fingers to feel numbers when cold. Our implant demonstrates in animal model studies that this effect can be produced in a programmable way, directly and locally to targeted nerves, even those deep within surrounding soft tissues.”

So, how does it work?

The implant leverages a simple concept – evaporation. It contains a liquid coolant that is prompted to evaporate at the specific location of a sensory nerve. 

To elaborate, the device works by wrapping around nerves softly, to deliver precise and targeted cooling. This in turn numbs nerves and blocks pain signals to the brain. An external pump helps the user to remotely activate the device and control its intensity. Once the device is no longer required, it is naturally absorbed into the body — “bypassing the need for surgical extraction”.

At the thickness of a sheet of paper, the soft, elastic nerve cooling device is ideal for treating highly sensitive nerves.

Study co-author Dr. Matthew MacEwan of Washington University School of Medicine in St. Louis said that as nerves become cooler, the signals that travel through them become slower – eventually stopping completely. 

“We are specifically targeting peripheral nerves, which connect your brain and your spinal cord to the rest of your body. These are the nerves that communicate sensory stimuli, including pain. By delivering a cooling effect to just one or two targeted nerves, we can effectively modulate pain signals in one specific region of the body,” he said.

Ilustration of the implantable device inside an arm. The red oval indicates pain. Source: Northwestern University

Includes an integrated senor to monitor the temperature of the nerve

The device contains tiny microfluidic channels to induce the cooling effect. While one channel contains the liquid coolant perfluoropentane (which is already clinically approved), a second channel contains dry nitrogen. When the liquid and gas flow into a shared chamber, a reaction takes place causing the liquid to immediately evaporate. Concurrently, a tiny integrated sensor monitors the temperature of the nerve to ensure that it doesn’t get too cold, which could damage the tissue.

“By monitoring the temperature at the nerve, the flow rates can be adjusted automatically to set a point that blocks pain in a reversible, safe manner. On-going work seeks to define the full set of time and temperature thresholds below which the process remains fully reversible,” said Rogers.

Former cooling therapies and nerve blockers have limitations, which the new device overcomes. Cryotherapies, for example, approach large areas of tissue, which could lead to unwanted effects. Here, Northwestern’s tiny device is just five millimeters wide and precisely targets only the affected nerves. This spares surrounding areas from unnecessary cooling.

“You don’t want to inadvertently cool other nerves or the tissues that are unrelated to the nerve transmitting the painful stimuli,” said MacEwan. “We want to block the pain signals, not the nerves that control motor function and enable you to use your hand, for example.”

The final disappearing act

The device isn’t Rogers’ first attempt at a bioresorbable electronic one. 

The Rogers lab introduced the concept of transient electronics in 2012, and in 2018, Rogers, MacEwan, and colleagues demonstrated the world’s first bioresorbable electronic device — a biodegradable implant that speeds nerve regeneration. Then, in 2021, Rogers and colleagues introduced a transient pacemaker.

All components of the devices naturally absorb into the body’s biofluids over days or weeks, without requiring surgical extraction.

“If you think about soft tissues, fragile nerves, and a body that’s in constant motion, any interfacing device must have the ability to flex, bend, twist, and stretch easily and naturally,” Rogers said. “Furthermore, you would like the device to simply disappear after it is no longer needed, to avoid delicate and risky procedures for surgical removal.”



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Primary Election 2022: Pennsylvania Lt. Gov. John Fetterman undergoes successful procedure to implant pacemaker after stroke

HARRISBURG, Pennsylvania — Pennsylvania Lt. Gov. John Fetterman, the leading contender in Tuesday’s Democratic primary for U.S. Senate, underwent a successful procedure to implant a pacemaker following last week’s stroke.

“Doc just called me, Joo’s procedure is over and it was PERFECT!,” Fetterman’s wife, Gisele, tweeted.

According to Fetterman’s campaign, the pacemaker will help protect his heart and address the underlying cause of his stroke, atrial fibrillation (A-fib), by regulating his heart rate and rhythm.

The 52-year-old Fetterman, who has been hospitalized all weekend, previously insisted the health emergency wasn’t slowing his campaign.
On Friday morning, before Fetterman was to appear at a scheduled campaign event at Millersville University, Fetterman’s wife “noticed that John was not himself, and shortly after he started slurring his speech and he was taken to the hospital,” a campaign spokesperson said.
In a 16-second video released by his campaign, a seated Fetterman, speaking clearly, explained that he “just wasn’t feeling very well” on Friday and decided to go to the hospital at the urging of his wife. He detailed the situation further in a written statement.

“I had a stroke that was caused by a clot from my heart being in an A-fib rhythm for too long,” Fetterman said. He said the doctors were able to remove the clot, “reversing the stroke,” and got his heart under control.

“The good news is I’m feeling much better, and the doctors tell me I didn’t suffer any cognitive damage,” he said in the statement.
Questions about Fetterman’s health swirled throughout the weekend after he canceled scheduled public appearances Friday, Saturday and Sunday. His campaign cited a health issue but was not specific until Sunday.

Democrats see the race to replace Pennsylvania’s retiring Republican Sen. Pat Toomey as one of their best opportunities to pick up a Senate seat this fall. Voters are now deciding the general election nominees for both parties.

The GOP primary features celebrity heart surgeon Mehmet Oz, former hedge fund executive David McCormick and conservative commentator Kathy Barnette, among others. Democrats are picking from a four-person field that includes Fetterman, three-term U.S. Rep. Conor Lamb and state Rep. Malcolm Kenyatta.

Copyright © 2022 by The Associated Press. All Rights Reserved.



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Nonsurgical Implant Could Help Overcome Obesity by Killing Cells Producing Ghrelin, the “Hunger Hormone”

In this illustration, an implant (blue and gray) creates a feeling of fullness by pressing on the stomach and, when activated by a laser (black), killing cells that produce the hunger hormone. Credit: Adapted from ACS Applied Materials & Interfaces 2022, DOI: 10.1021/acsami.2c00532

When dieting and exercise aren’t enough, weight-loss surgery can be an effective obesity treatment. But people who don’t want surgery have other options, including insertion of an appetite-suppressing balloon or other implant in the stomach. Now, researchers report in ACS Applied Materials & Interfaces that they have augmented that procedure in laboratory animals by coating an implant with a laser-activated dye that kills cells producing ghrelin, the “hunger hormone.”

Implants can be inserted in the stomach through the mouth after local anesthesia. In 2019, Hwoon-Yong Jung, Jung-Hoon Park and colleagues designed a new type of implant. The “intragastric satiety-inducing device” (ISD) consists of a stent — which lodges in the lower esophagus — attached to a disk that rests in the opening to the stomach. The disk has a hole in the center to let food through. Tests in pigs showed that the ISD lowered food intake and weight gain by enhancing the feeling of fullness and reducing levels of ghrelin, which is produced by cells near the top of stomach. But the device caused complications, including

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Paralysed man uses brain implant to communicate first words in three months: ‘I want a beer’

A completely paralysed man, who was left unable to communicate for months after losing the ability to even move his eyes, has used a brain implant to ask his caregivers for a beer.

Composing sentences at a rate of just one character per minute, the man also asked to listen to the band Tool “loud”, requested a head massage from his mother, and ordered a curry – all through the power of thought.

The man, who is now 36, had two square electrode arrays surgically implanted into his brain to facilitate communication in March 2019 after being left in a locked-in state as a result of amyotrophic lateral sclerosis (ALS).

People suffering from the progressive neurodegenerative disease have an average life expectancy after diagnosis of two to five years, though they can live much longer. (The late physicist Stephen Hawking lived another 55 years after his diagnosis, relying towards the end of his life on a communication device controlled by a single cheek muscle.)

Until now, a brain implant has not been tested on a completely locked-in patient, and it was not known whether communication was even possible for people who had lost all voluntary muscular control.

“Ours is the first study to achieve communication by someone who has no remaining voluntary movement and hence for whom the BCI is now the sole means of communication,” said Dr Jonas Zimmermann, a senior neuroscientist at the Wyss Center.

“This study answers a long-standing question about whether people with complete locked-in syndrome – who have lost all voluntary muscle control, including movement of the eyes or mouth – also lose the ability of their brain to generate commands for communication.”

Working with researchers at the Wyss Center for Bio and Neuroengineering in Geneva, Switzerland, the ALS patient consented to having the brain implant fitted when he still had the ability to use eye movement to communicate in 2018.

Two microelectrode arrays, each 3.2mm square, were inserted into the surface of the motor cortex in the frontal lobe of the brain

(Wyss Center for Bio Neuroengineering)

It took three months of unsuccessful attempts before a configuration was achieved that allowed the patient to use brain signals to produce a binary response to a speller program, answering ‘yes’ or ‘no’ when presented with letters.

It took another three weeks to produce the first sentences, and over the next year the patient produced dozens of sentences.

One of his earliest communications concerned his care, asking for his head to be kept in an elevated and straight position when there were visitors in the room.

He also requested different kinds of food to be fed through his tubes, including goulash soup and sweet pea soup. “For food I want to have curry with potato then Bolognese and potato soup,” one request stated.

He was also able to interact with his 4-year-old son and wife, generating the message: “I love my cool son.”

The research was detailed in a study published this week in the journal Nature Communications.

The study, titled ‘Spelling interface using intracortical signals in a completely locked-in patient enabled via auditory neurofeedback training’, noted that the BCI communication system can be used in a patient’s home, with some sessions even being performed remotely via the patient’s laptop.

The patient was provided auditory feedback of neural activity levels through a nearby speaker, which allowed them to adjust frequencies to generate ‘yes’ and ‘no’ responses

(Wyss Center/ Nature Communications)

The scientists behind the brain-computer interface technology are now seeking funding to provide similar implants for other people with ALS, which will cost close to $500,000 over the first two years of use.

“This is an important step for people living with ALS who are being cared for outside the hospital environment,” said George Kouvas, chief technology officer at the Wyss Center.

“This technology, benefiting a patient and his family in their own environment, is a great example of how technological advances in the BCI field can be translated to create direct impact.”

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