The approval was based on study of 62 subjects. Over four weeks, those who received the treatment showed a decrease in ADHD-RS by -31.4%. The control group showed a -18.4% decrease.
The FDA’s Carlos Pena said: “This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind.”
Trigeminal nerve stimulation is also being studied in Epilepsy and PTSD.
Join ApplySci at the 12th Wearable Tech + Digital Health + Neurotech Boston conference on November 14, 2019 at Harvard Medical School and the 13th Wearable Tech + Neurotech + Digital Health Silicon Valley conference on February 11-12, 2020 at Stanford University