Tag Archives: Tests & Procedures

Neuralink successfully implants its chip into a second patient’s brain

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Neuralink's brain chip has been implanted into a second patient as part of early human trials, Elon Musk told podcast host Lex Fridman on Saturday. The company hasn't disclosed when the surgery took place or the name of the recipient, according to Reuters.

Musk said 400 of the electrodes on the second patient's brain are working out of 1,024 implanted. "I don't want to jinx it but it seems to have gone extremely well," he said. "There's a lot of signal, a lot of electrodes. It's working very well." 

The device allows patients with spinal cord injuries to play video games, use the internet and control electronic devices using their thoughts alone. In May, the company announced that it was "accepting applications for the second participant" in trials following FDA approval. 

The original Neuralink implant patient, Nolan Arbaugh, described the surgery as "super easy." In a demo, the company showed how Arbaugh was able to move a cursor around the screen of a laptop, pause an on-screen music device and play chess and Civilization VI.

Arbaugh himself participated in the marathon podcast with Musk and Fridman. He said that the device allows him to make anything happen on a computer screen just by thinking it, helping reduce his reliance on caregivers. 

However, problems cropped up shortly after his surgery when some of electrodes retracted from his brain. The issue was partly rectified later on by modifying the algorithm to make the implants more sensitive. Neuralink told the FDA that in a second procedure, it would place the implant’s threads deeper into the patient’s brain to prevent them from moving as much as they did in Arbaugh’s case.

Neuralink previously tested its implant in animals, including chimps, and some of those testing practices have been the subject of federal investigations. 

Despite those issues, the company said it had over 1,000 volunteers for its second surgical trial. Musk said he expects Neuralink to implant its chips in up to eight more patients by the end of 2024.  

This article originally appeared on Engadget at https://www.engadget.com/neuralink-successfully-implants-its-chip-into-a-second-patients-brain-123013864.html?src=rss

Dr. Garmin will see you now

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There’s a reason smartwatches haven’t replaced clinically validated gear when you visit the hospital — accuracy and reliability are paramount when the data informs medical procedures. Even so, researchers are looking for ways in which these devices can be meaningfully used in a clinical setting. One project in the UK has explored if a Garmin Venu 2 and dedicated companion app could be used to free up doctors and nurses, six minutes at a time.

The Six Minute Walk Test (6MWT) is used to diagnose and monitor a number of cardiovascular maladies. This includes conditions like Pulmonary Hypertension that, if left untreated, are eventually fatal. “[The test has been] a cornerstone of hospital practice and clinical trials for decades all around the world as [...] a marker of how well the heart and lungs are working,” project leader Dr. Joseph Newman told Engadget. While a change in a blood test marker might be clinically relevant, he said “it’s probably more important to someone that they can walk to the shop and back.” 

The test requires a patient walk on a flat, hard surface for six minutes straight, which stresses the heart enough to measure its capacity. A professional tests the patient’s heart rate and blood oxygen levels at the start and end. While it’s simple and reliable, "it’s not perfect,” according to Dr. Newman. “This is why we’ve looked to change it in two important ways," he said, "can we make it shorter [...] and digitize it for remote use?"

After all, six minutes is a lifetime in a clinical setting, and patients dislike having to schlep all the way to their hospital just to walk up and down a corridor. It’s why Newman and Lucy Robertson — both researchers at the Royal Papworth Hospital in Cambridge — began looking for ways to revolutionize the test. They wanted to see if the test could be shortened to a single minute, and also if it could be carried out by a patient at home using a Venu 2. 

The watch was connected to a secure and dedicated clinical trial platform built by Aparito – a Wrexham-based developer – for testing. This was then sent out to patients who were instructed to wear the watch and walk outdoors to complete their own tests. “They’re asked to walk on flat, even, dry, relatively straight roads rather than in laps or circuits,” Dr. Newman said, with patients walking at their own natural pace.

“We carried out a product appraisal early on in the research process and were open-minded as to the brand or model,” said Dr. Newman. “Garmin came out on top for a few reasons; we can access raw data as well as Garmin’s algorithmically-derived variables,” he said. Because the research was being funded by a charity, the British Heart Foundation, the watch had to offer good value for money. It helped that Garmin, with its established health research division, gave the team “confidence in the accuracy of the sensors,” not to mention the fact that Aparito feels that “the Garmin SDK is relatively easy to work with,” he added. 

But while Garmin is in use right now, there’s no reason this setup couldn’t eventually work with a number of other brands. “As long as the technology works, it’s accurate, reliable and patients accept it, then we’re not tied to any brand,” he said.

There are several benefits in giving patients the ability to run the tests at home: it’s more representative of the demands of their actual life, and patients can retake the test at regular intervals, making it easier to track that person’s health over time. “We can see real value in providing patients with pulmonary hypertension with an app and smartwatch to monitor their progress,” Dr. Newman said. “It’s unlikely to ever fully replace the need for in-person hospital reviews, but it will likely reduce their frequency.”

The results of the study right now suggest cutting the test to one minute has no detrimental effect on its outcome or accuracy, and that patients are far more likely to run the test regularly if they’re able to do so at home. “It’s likely that the upfront costs of wearables [to a hospital] may be offset by the longer term reduction in hospital visits,” Dr. Newman said. If that turns out to be right, it means clinicians can better focus their time and efforts where their expertise is more valuable.

This article originally appeared on Engadget at https://www.engadget.com/dr-garmin-will-see-you-now-160013340.html?src=rss

CRISPR-based gene editing therapy approved by the FDA for the first time

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In a landmark decision, the FDA greenlit two new drugs for the treatment of sickle cell disease in patients 12 and older, one of which —Vertex’s drug Casgevy — is the first approved use of genome editing technology CRISPR in the US. Bluebird Bio’s Lyfgenia also is a cell-based gene therapy, however, it uses a different gene modification technique to deliver tweaked stem cells to the patient.

Both approvals cultivate new pathways for the treatment of sickle cell disease, which is an inherited blood disorder that is characterized by red blood cells that can’t properly carry oxygen, which leads to painful vaso-occlusive crises (VOCs) and organ damage. The disease is particularly common among African Americans and, to a lesser extent, among Hispanic Americans. Bone marrow transplants are currently the only cure for sickle cell disease, but they require well-matched donors and often involve complications.

While both drug approvals use gene editing techniques, Casgevy’s CRISPR/Cas9 genome editing works by cutting out or splicing in DNA in select areas. Patients first have blood drawn so that their own stem cells can be isolated and edited with CRISPR. They then undergo a form of chemotherapy to remove some bone marrow cells, so the edited stem cells can be transplanted back in a single infusion.

Both drug approvals are based on studies that evaluated the effectiveness and safety of the novel therapies in clinical patients. With Casgevy, study participants reported that they did not experience “severe VOCs” for at least 12 consecutive months during the 24-month follow-up. Similarly, patients on Lyfgenia did not experience a “pain crisis” for six to 18 months after the therapy.

The FDA's decision comes shortly after UK regulators, as well as the National Health Regulatory Authority in Bahrain both approved Vertex’s Casgevy. The approval for a CRISPR-based treatment creates opportunity for further innovation in the gene editing space — for treatments ranging from cancers to heart diseases to Alzheimer’s. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited,” Nicole Verdun, director of the Office of Therapeutic Products at the FDA’s Center for Biologics Evaluation and Research said. Casgevy is still currently under review by the European Medicines Agency.

This article originally appeared on Engadget at https://www.engadget.com/crispr-based-gene-editing-therapy-approved-by-the-fda-for-the-first-time-200726474.html?src=rss

UK authorizes first gene therapy for treating sickle cell disease

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In a landmark decision, the UK’s Medicines and Healthcare products Agency (MHRA) approved the use of a gene-editing therapy called Casgevy for patients with sickle cell disease and beta thalassemia — both of which are hereditary disorders related to genetic mutations of the red blood cells. The treatment, manufactured by Vertex, is the first-ever approved therapy that utilizes CRISPR-based gene editing technology to treat eligible patients.

The UK approval of the novel therapy is informed by two previous global clinical trials that indicated the treatment's efficacy. 97 percent of patients using Casgevy were relieved of severe pain associated with the blood disorders for at least 12 months after treatment during the trials. The results suggest that the gene editing treatment could replace the current standard for care. Stem cell therapy and bone marrow transplants are currently the only pathways to cure sickle cell disease and beta thalassemia, however, they involve a lot of risks.

Both sickle cell disease and beta thalassemia are blood disorders characterized by defective red blood cells that can’t carry oxygen, and require patients to get monthly blood transfusions that can be costly and time-consuming. Casgevy works by specifically targeting the genes in the bone marrow stem cells that produce faulty blood cells. For the treatment to work, a patient’s stem cells need to be extracted from their bone marrow, edited in a lab and then re-infused into the patient.

Despite its promising outlook, CRISPR-based therapies may not be easily available to the general public. Gene editing is an expensive endeavor. The Innovative Genomics Institute (IGI) estimates that the average CRISPR-based therapy will cost between $500,000 and $2 million per patient. The IGI has built out an ‘Affordability Task Force’ to tackle the issue of expanding access to these novel therapies.

Aside from costliness, gene editing therapies offer huge promise to innovate treatment pathways for rare conditions including neurodegenerative diseases, cancer and muscular atrophy. More importantly, this landmark approval for Casgevy “opens the door for further applications of CRISPR therapies in the future,” Prof Dame Kay Davies, a scientist from the University of Oxford, said. And new iterations of gene editing technologies may even surpass CRISPR in the future.

Casgevy is still being reviewed by regulatory agencies for safety standards in other countries, including the United States and Saudi Arabia. A marketing application, the first step towards approval for the therapy, was recently validated by the European Medicines Agency.

This article originally appeared on Engadget at https://www.engadget.com/uk-authorizes-first-gene-therapy-for-treating-sickle-cell-disease-184130989.html?src=rss