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Last week, the Food and Drug Administration approved Monarque's trimeminal nerve stimulation system (eTNS), a medical device that produces mild brain stimulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). with treatment in children from 7 to 12 years old.
Judging by the comments and emails from readers that Gizmodo has heard about our article on the device, it is clear that there are many misconceptions and concerns regarding the use of neurostimulation to treat ADHD. A reader, by email, has compared it to electric shock therapy (more commonly known as electroconvulsive therapy or ECT) and fears that it will destroy the brain cells of children who use it.
"THIS IS BARBARIC. The public needs to know this before their children's brains are fried, "the reader wrote.
There are a few things to decompress here. The first is the stereotype that the current form of ECT is particularly dangerous.
It is true that in the past, ECT was practiced (and sometimes forced) on patients using large amounts of electricity that would pass through the brain and that this could seriously harm people and cause muscular convulsions so powerful that they could fracture bones. But nowadays, patients undergo electrochemistry under total sedation and with lower and safer doses of electricity, thus avoiding the possibility of severe convulsions. Electroshocks still have side effects, including potential memory loss, and are considered best for people with depression or bipolar disorder who have not responded to other treatments – but they do not cause damage to the brain if properly used.
Leaving this aside, the Monarch eTNS system is nothing like modern ECT, according to James McGough, a clinical psychiatrist at the University of California at Los Angeles. McGough, who is also chief of staff at UCLA's Resnick Neuropsychiatric Hospital, and his team have studied the Monarch system as part of the pivotal clinical trial that led to the approval of the device by the FDA. He told Gizmodo that he had no financial relationship with Neurosigma; he received a grant from the National Institutes of Health to study the device.
Although the FDA found the device to be safe, the agency said in its statement that it had some detrimental effects, including drowsiness, increased appetite, headaches, and fatigue.
McGough said the two strands of the device, attached to a bandage on the forehead, provide a slight tingling sensation. Children who use the device will probably not experience this sensation very often, as the device is designed to be worn for approximately eight hours.
"If you use a tuning fork and put it on your forehead, you will get more vibrations than you would in this way. We do not connect people to a wall outlet, we use a 9-volt lithium battery to generate a charge in eight hours – it's so minimal, "he said. "But this stimulation of your forehead actually feeds and adjusts the [brain activity of] areas of the brain involved in ADHD. "
In terms of who would be best able to use the treatment, the FDA has approved the device – on prescription – for children ages 7 to 12 who are currently not taking any prescription medication. Most people with ADHD who rely on stimulants (front-line ADHD treatment) like Ritalin respond to it, but about a quarter do not. These patients sometimes use other nonstimulant drugs, such as the selective norepinephrine reuptake inhibitor, atomoxetine. Monarch's effectiveness in reducing ADHD symptoms was, on average, similar to the effect seen with non-stimulant drugs, which are about half as effective as stimulants.
Nevertheless, for children who do not respond to medication for ADHD, who do not tolerate side effects, or whose families would prefer to avoid medication, Monarch may be an option. For some children, the four-week diet may improve the symptoms enough so that they do not require any additional treatment. But he is also considering a future in which doctors could prescribe the device in combination with drugs, as a non-compliant use, to better manage the symptoms of ADHD.
While McGough is optimistic about the future of the ADHD treatment device, Sandra Loo, his lead co-author and professor at the Brain Research Institute at the University of Los Angeles ( UCLA), says that there is still a lot of research to be done before adopting it. by doctors. Among future studies, the key would be to find the ideal patients who best respond to treatment. In their study, about half of the children felt an improvement after using the device.
"We plan to continue research to identify the predictive measures of the TNS response," Loo told Gizmodo via email. "I think it makes sense to do this before regularly using TNS."
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