A recent study has found that toddlers who stare at screens for two hours or more daily tend to behave poorly or have ADHD.
When ADHD's diagnostic rates in children skyrocketed, a new medical device to treat the disease could soon come onto the market.
The US Food and Drug Administration announced on Friday that it allowed marketing the first medical device to treat ADHD. The approval was granted to Los Angeles-based life science company NeuroSigma Inc.
The Monarch's External Trigeminal Nerve Stimulation System (eTNS) is the prescription device for children 7 to 12 years of age who are currently on no prescription ADHD medication.
The Monarch eTNS – an instrument the size of a cell phone – is designed for home use under adult supervision. It is connected to a small spot on the forehead of the patient via a cable and generates a low electrical impulse to the brain.
ADHD News: Diagnostic scores for ADHD have increased 30% in 8 years.
The compound causes tingling sensation on the skin, according to the FDA Low electrical stimulation to the branches of the trigeminal nerve, which then sends therapeutic signals to the parts of the brain associated with ADHD. The FDA says that eTNS increases activity in the brain regions that are known to be important for regulators' attention, emotions, and behaviors.
"This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients using mild nerve stimulation, a premiere of its kind," said Carlos Peña, director of the Department of Neurological and Physical Medical Devices at the Center for Devices and Radiological Health of the FDA, in a statement.
Before Friday, the FDA had granted only drug treatment for ADHD.
According to clinical studies, the FDA has been able to maintain the response time of eTNS for up to four weeks: In a study of 62 children with moderate to severe ADHD, subjects who received ADHD were shown to have a "statistically significant improvement" compared to ADHD Children who had received a placebo device.
After four weeks in the study, the average ADHD RS score – which was used to measure ADHD – dropped 34.1 points to 23.4 points. This is offset by a decline of 33.7 to 27.5 points in the placebo group.
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ADHD, a A frequent and growing disorder that begins in childhood involves difficulty concentrating to stay and pay attention, as well as to control the behavior, and a lot of activity. The symptoms of ADHD must be long-lasting, impair one's ability to function, and leave the person behind their normal development for their age.
In the United States, the number of children diagnosed with ADHD has increased by more than 30% over the last eight years, with 2.4 million commercially insured American children diagnosed with the disease in 2014.
The FDA says Monarch eTNS has several side effects – drowsiness, an increase in appetite, sleep disorders, teeth grinding, headaches and fatigue – but no serious adverse events related to its use.
The device should not be used on children under the age of 7, says the FDA, or in patients with an active implantable pacifier, active implantable neurostimulators, or body-worn devices such as insulin pumps. The device should also not be used in the presence of radiofrequency energy such as magnetic resonance imaging (MRI) or mobile phones. The test was not measured in an MRI machine and the low electromagnetic energy of the phone could interfere with the treatment.
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