"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.
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.
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
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 was also studied as a possible treatment for traumatic brain injury in veterans
Michelle Watson contributed to this report