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A new device could offer an effective way of diagnosing myalgic encephalomyelitis, also known as chronic fatigue syndrome. People with the disease experience symptoms such as fatigue, sleep abnormalities, and pain, but it’s been notoriously hard to diagnose.

Stanford’s Ron Davis first got the idea for the device back in 2015 while attending an event at the Institute of Medicine where panelists debated whether the disease was a real condition, he recalled.

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But he knew it was real. His son, then in his late 20s, had been living with the disease for almost two years. It’s estimated that ME/CFS affects 2.5 million Americans, but the true numbers are unknown, as more than 80% of people who have the disease don’t have a diagnosis for it, according to the advocacy group MEAction. Davis’ own son had gone through a nearly five-year struggle to get his own diagnosis of the illness.

“It has been viewed as a psychosomatic disease,” said Davis, a biochemist and geneticist. “When doctors make their usual measurements, these patients come out to be normal. But, they’re not measuring enough things.”

Now, Davis and other scientists at Stanford and the University of California, Irvine, have created a device that could make diagnosing ME/CFS much simpler. The research was published Monday in Proceedings of the National Academy of Sciences. Known as a “nanoneedle,” the new device picks up on certain changes in electrical signals to identify people with ME/CFS.

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“It’s an important finding because it demonstrates a biological difference between people with ME/CFS and healthy individuals,” said Maureen Hanson, a molecular biologist at Cornell University who was not involved in the research. “There are still people who still don’t believe the disease is a real biological illness rather than a mental problem.”

The small device that Davis and his colleagues created was originally developed to detect changes in electrical signals when cancer cells were exposed to different treatments. They then decided to try it with samples from ME/CFS patients. Previous research from others had suggested that the disease causes cells to use up energy more quickly and have a more difficult time recovering from illness and other stressors.

And so the researchers decided to mimic this by stressing cells from 20 healthy controls and 20 ME/CFS patients by exposing them to increased levels of salt.

“We’re forcing them to consume [energy] and they’re not happy in this new environment,” said Rahim Esfandyarpour, a bioengineer at the University of California, Irvine, and the study’s lead author. “When they face this new environment, their reaction is different than the reaction of healthy cells.”

The cells from those with ME/CFS showed a clear spike in electrical signals, indicating a heightened stress response. In contrast, the samples from the control group were fairly level. Davis said he was surprised that there was such a delineation between the two groups.

“It was a very, very clear signal. The healthy cells had no signal whatsoever,” Davis said.

Previous attempts at distinguishing ME/CFS samples had almost always resulted in some kind of overlap with healthy controls, Hanson said. In her own work studying the gut microbiome, she was able to show that the microbiota in those with ME/CFS was different, on average, but there were still some commonalities with healthy people. And although the current study was only in a small population, “it’s still impressive that there’s this complete discrimination,” Hanson said.

Researchers don’t yet know what’s behind the discrepancy in the two groups. What’s also unclear is whether the difference is unique to ME/CFS or whether other autoimmune diseases would also cause similar spikes in electrical signals.

“I think the next thing they need to do is test a lot more patients and compare a lot of other diseases — like MS — to make sure what they’re seeing is truly because of ME/CFS,” said Brian Vastag, a former journalist for the Washington Post who has been outspoken about his experience living with ME/CFS.

Davis and Esfandyarpour already have plans to do just that and also intend to use the device to test potential new drugs for the disease, which currently has no treatments approved by the Food and Drug Administration. “A diagnostic test is probably the biggest thing that could happen for patients right now,” Vastag said. “Treatment would be huge, but most patients still wait years to get a diagnosis.”

For patients like Vastag and family members like Davis and Hanson — whose adult son also has ME/CFS — even the possibility of a diagnostic is promising. Although it can’t help Davis’ son, who is now bedridden, unable to speak, and relies on a feeding tube due to his ME/CFS, the new device “offers a tiny little point of hope as opposed to none, which has been the case for the past 30 years,” he said.

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