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Parents are wary of the new, FDA-approved device for children with ADHD



The approval of the US Food and Drug Administration for the first medical device to treat ADHD in children between the ages of 7 and 12 is met with "cautious optimism" from parents and advocates.

The new device known as the Monarch eTNS system costs parents about $ 1,000 and is not yet insured. It is the size of a cellphone and is attached to the forehead of a patient by attaching a small patch. It provides little stimulation to the parts of the brain that are thought to be involved in ADHD.

"This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients by applying mild nerve stimulation, a first of its kind," said Carlos Peña, who heads the Department of Neurological and Physical Medicine of the FDA.

A four-week clinical study of 62 children with moderate to severe ADHD showed a "statistically significant improvement" in reducing their symptoms. However, some doctors are cautiously optimistic and require more research before parents buy these devices.

"The study is based on a very small sample size," Dr. Max Wiznitzer, Co-Chair of the Advisory Board for Children and Adults with ADHD. "Most of the known ADHD medications ̵

1; Ritalin, Adderall – have a much larger sample size, so one study is not enough to prove its efficacy."

  approved by the FDA.
NeuroSigma Inc.
NeuroSigmas Monarch eTNS system is the first non-drug treatment for childhood ADHD approved by the FDA.

However, known side effects of these medications include abdominal pain, decreased loss of appetite, and sleep disturbances.

The new Monarch eTNS device, however, is not without its own side effects such as drowsiness, headaches and increased appetite.

"It will probably be a good treatment for children with moderate ADHD symptoms," Dr. Wiznitzer. "But my question is, is this device sufficient on its own?"

Dr. Andy Leuchter, director of the Transcranial Magnetic Stimulation Clinical and Research Program at UCLA, was involved in the research phase of the device's clinical trial. Dr. Leuchter believes that the Monarch eTNS system can trust parents, but also says that more research, including the potential combination with other known ADHD drugs, would help.

"This is so close to a device that is free of side effects that you will get," he said. "So there is a very low risk of seeing if there is any benefit."

But even for parents who have difficulty helping their children to respond to the effects of their own ADHD medication, the device shows some discomfort.

Andrea Frank is the mother of two teenage boys in Lodi, Wisconsin, both of whom were diagnosed with ADHD when they were four years old but have now opted for treatment. She founded a virtual support group for parents of children with ADHD, which has more than 40,000 members worldwide.

"Personally, I would not go like this," she said. "I see a lot of frustrated parents who feel like they hit a wall, but since it's an electrical appliance-based device, parents just have a fear of using it."


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