FDA Cleared and Pending Neurodiagnostic Systems and Non-invasive Neuromodulation Devices
mmon. This disorder is more prevalent in boys than girls. This disorder is marked by deficits in attention and executive system functions, including impairments in behavioral regulation for those patients presenting with the hyperactive subtype. Those ADHD patients who present with hypoactivation of anterior cortical structures on resting and active braining mapping are typically good candidates for stimulant therapy. Up until now, outside of behavioral therapy training for caregivers, there have been no effective non-pharmacological treatments for enhancing attention and improving inhibitory control in ADHD. A landmark study showed promising efficacy using transcutaneous stimulation of the trigeminal nerve as a potentially effective treatment for ADHD: https://www.sciencedirect.com/science/article/abs/pii/S1935861X1400388X. This approach was later confirmed in a larger randomized controlled double blind study: https://pubmed.ncbi.nlm.nih.gov/30768393/. For a recent view of the role of electrical stimulation of the cranial nerves in treating cognitive and neuropsychiatric disorders visit: https://www.sciencedirect.com/science/article/pii/S1935861X20300413
The Attendor-TNSTM is a transcutaneous neuromodulation medical device that targets the trigeminal nerve at the supraorbital branch (above the eyebrows). The device is typically worn at night during sleep. The main mechanism of actions relevant to ADHD are thought to work by inhibiting activity where impulses are generated in the brain and activating the main dorsal branch of the attention network in the right hemisphere of the cortex. Given this dual action this form of treatment has been approved by the FDA in the United States and our Attendor-TNSTM is pending FDA clearance for the treatment of ADHD in ages 7-17.
Other Medical Devices for: