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Modius Stress device cleared by FDA for anxiety disorder treatment

April 17, 2024

The FDA granted medical device clearance to Neurovalens’ Modius Stress, a transdermal, home-use neurostimulation device that is indicated in adults 22 years and over to treat symptoms of generalized anxiety disorder (GAD).

What’s the potential patient impact?

GAD is a long-term condition that causes people to feel anxious most days about a wide range of situations and issues, rather than a specific event. GAD can cause both psychological and physical symptoms including feeling restless or worried, having trouble concentrating or sleeping, dizziness and heart palpitations.

How does the device work?

Neurovalens’ Modius Stress delivers non-invasive, low-level electrical stimulation to the skin behind the ears through two self-adhesive electrode pads. Users are instructed to wear the device for 30 minutes before bed, during which time they can still engage in other activities like watching TV or reading.

What’s the evidence supporting the FDA clearance?

The device’s clearance was secured based on data from two phase III clinical trials carried out in mid-2023 in the UK and Ireland by Ulster University and in India by the Indian Center of Neurophysiology (ICN). The trials were both randomized, double-blind, sham-controlled studies that included patients diagnosed with GAD.

The UK study results showed that, for those who used the Modius device for 30 minutes per day for 4-weeks, individuals achieved a four point or more reduction in GAD-7 score from the baseline visit to the week four visit when compared to the sham group. Similar results were shown in the India study, where participants were asked to complete 20 sessions 3 to 5 times per week.

Sources:

(2024, April 9). Neurovalens. Neurovalens receives FDA clearance for medical device to treat anxiety. [News release] https://neurovalens.com/blogs/news/neurovalens-receives-fda-clearance-for-medical-device-to-treat-anxiety