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Treatment for ADHD: FDA OKS is the first medical device for treating children with ADHD



"This new device provides a safe, non-drug treatment for ADHD in children with mild nerve stimulation, the first of its kind," said Carlos Peña, Director of the Neonological and Physical Medical Devices Unit at FDA Appliance and Radiology Center

called Monarcho. external trigeminal nerve stimulation system, eTNS, and sold by NeuroSigma, treatment is available on prescription only and should be supervised by the caregiver. 19659002] Pocket device wired to a small adhesive patch on the child's forehead over the eyebrows. Designed to be used at home during sleep, it provides "tingling" to the branches of the electric stimulation crane that give the senses from face to brain.

A clinical study of 62 children has shown that eTNS increases the activity of brain regions that regulate attention, emotions and behavior, all major components of ADHD.

Compared to placebo, children taking the device had a statistically significant improvement in the symptoms of ADHD, said the FDA, although the improvement may take up to four weeks

The authors of the clinical study called for further studies to investigate whether the response to treatment will continue over time and its duration. potential effects on brain development over a long period of time.

This device is currently not insured on the NeuroSigma website and the starter kit may cost a little over $ 1
,000.

No serious side effects reported during the clinical trial, FDA said, but common side effects may include fatigue, drowsiness or sleep disorder, tooth shrinkage, headache and increased appetite

  10% of US children diagnosed with ADHD
The device should not be used by children under 7 years of age or by a child with an insulin pump, pacemaker or infusion. lanted neurostimulator. It should also not be used near a mobile phone, said the FDA, because low electromagnetic energy levels can stop treatment.

ADHD is one of the most common child developmental disorders. According to the US Centers for Disease Control and Prevention, children with ADHD may have difficulty drawing attention to controlling impulsive behavior or being too active. Doctors usually recommend several treatment options for children: medications, behavioral changes, or both. Some of the most commonly used drugs are amphetamine / dextromamphetamine known as Adderallas; methylphenidate, known as Concerta or Ritalin; and lisdexamphetamine known as Vyvanse.

Though the Atlantic Pediatrician dr. Jennifer Shu does not know the specifics of the eTNS device, he said he appreciated the non-drug treatment options for ADHD.

The family said this system could be a good choice for your child, ”said Shu.

The device has been previously approved for treating epilepsy and depression in Europe and Canada. Studies conducted by UCLA have shown that stimulation reduced the activity of seizures by inhibiting excessive neurons in one part of the brain, stimulating blood flow in areas that control mood, attention, and executive function.

The device was also studied as a possible treatment for traumatic brain injury in veterans

Michelle Watson contributed to this report


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