Medical Professionals Reference (MPR)FDA Clears Noninvasive Device for Generalized Anxiety Disorder

Noninvasive Anxiety Treatment Breakthrough: FDA Clearance of Modius Stress Device

The FDA has recently cleared Modius Stress, a transdermal neurostimulation device, for use in adults suffering from generalized anxiety disorder (GAD). This device, which utilizes low-level electrical stimulation behind the ears, offers a noninvasive treatment option that could reshape how physicians approach anxiety management. Grounded in robust clinical evidence from multi-center trials, Modius Stress promises significant reductions in GAD symptoms, presenting a potential shift in therapeutic strategies for anxiety disorders.

Key Points:

• FDA Approval: Modius Stress received FDA clearance as a home-use device for treating symptoms of generalized anxiety disorder in adults aged 22 and older, highlighting its safety and efficacy.
• Device Design: It administers low-level electrical stimulation transcutaneously via self-adhesive electrode pads placed behind the ears, intended for daily use before sleep.
• Clinical Trials Evidence: Data from two phase 3 trials, conducted by Ulster University and the Indian Center of Neurophysiology, demonstrated significant efficacy over sham controls, with the device users experiencing marked reductions in GAD-7 scores.
• Treatment Protocol: Patients use the Modius Stress device for 30 minutes per day over a period of 4 weeks, potentially integrating treatment seamlessly into their daily routines without disrupting regular activities.
• Impact on GAD Symptoms: In the UK trial, 75% of the device users achieved a 4 point or more decrease in GAD-7 scores, in contrast to 51% in the sham group, signaling a substantial clinical improvement.
• Superior Results in Indian Study: The results were even more pronounced in the Indian study, with 97% of participants showing significant improvements, solidifying the device’s effectiveness across diverse populations.
• Ease of Use and Accessories: The package includes a Modius headset, 150 electrode pads, alcohol wipes, and a USB charging cable, ensuring up to 3 months of treatment without additional purchases.
• Expert Commentary: Dr. Jason McKeown, CEO of Neurovalens, emphasizes the device’s role in addressing the underlying issues of GAD, potentially improving patient outcomes in the 6.8 million adults affected in the US alone.

Daily transcranial magnetic stimulation (TMS) over left dorsolateral prefrontal cortex (DLPFC) produced a significant antidepressant response, defined as greater than 50% improvement in baseline Hamilton Rating Scale for Depression (HRSD) scores. (Frontiers in Human Neuroscience)

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