FDA OKs First Medical Device To Treat ADHD In Children

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On Friday April 19th, a medical device was given the green light by the US Food and Drug Administration for the treatment of ADHD. This is a first, and hopeful news for those looking for non-pharmaceutical options to help their children cope with the disorder.

ADHD is a condition that typically starts in childhood and is characterized by hyperactivity, inattention, and impulsivity. Children with ADHD often struggle in school and at home. Their symptoms can cause difficulty when it comes to social interactions such as making friends. Up until recently, the typical treatments available were pharmaceuticals or behavioral therapy, or a combination of both.

The new medical device, called the Monarch external Trigeminal Nerve Stimulation System (or eTNS) is a device that has been approved for use in children aged 7 to 12 years old who are currently not on medication for their disorder. The device works by sending a low-level nerve pulse to specific regions of the brain that factor into the exhibition of ADHD symptoms.

The device, developed by NeuroSigma, is small enough that it could fit into a pocket and connects via wire to a patch attached to the child's forehead. Ideally, the device would be worn during the night while the child was asleep. The way it works is that it sends a tingling impulse to a cranial nerve via the face that communicates with areas of the brain that control attention, emotional regulation and behavior. The use of this device in clinical trials was shown to increase activity in the brain in those areas, significantly improving ADHD symptoms in participants.

The clinical study conducted by researchers found that improvements while using this treatment in a sample of 62 children were statistically significant as compared to placebo. However, some medical professionals think more research should be done to determine long term effects and efficacy when using this method over time.

The device will be available by prescription, and will likely have a price tag of just over $1000 for the initial treatment kit. The use of the device will need to be monitored by a parent or guardian. Side effects in the clinical trial were mild but included fatigue, headaches, tooth clenching, and increased appetites.

You can learn more about this device on the NeuroSigma website here.

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