Keypoint: The device is designed to transcutaneously deliver low-level electrical stimulation to the skin behind the ears.
The Food and Drug Administration (FDA) has cleared Modius Stress, a transdermal, home-use neurostimulation device that is indicated to treat the symptoms of generalized anxiety disorder in adults aged 22 and older, when used for approximately 4 weeks.
The device is designed to transcutaneously deliver low-level electrical stimulation to the skin behind the ears, over the mastoid processes, through 2 self-adhesive electrode pads. The treatment is delivered for a period of 30 minutes before bed; users can engage in other activities while using the device. The prescription device includes a Modius headset, 150 electrode pads (enough for approximately 3 months use), alcohol cleansing wipes, and a micro USB charging cable.
According to the Company, the clearance was granted based on data from two phase 3 trials conducted by Ulster University in the UK and Ireland and the Indian Center of Neurophysiology in India. Both were randomized, double-blind, sham-controlled trials that included patients diagnosed with generalized anxiety disorder.
In the UK study, participants were instructed to use their allocated devices for 30 minutes per day for a 4-week duration at home. Results showed more patients in the Modius Stress group achieved a 4 point or more reduction in Generalized Anxiety Disorder (GAD)-7 score from the baseline visit to the week 4 visit compared with the sham group (75% [27 out of 36] vs 51% [20 out of 39], respectively). The Modius Stress group had a reduction of 5.41 in GAD-7 score vs a reduction of 3.96 in the sham group.
Similar results were seen in the India study, where participants were asked to complete 20 sessions (30 minute duration) approximately 3 to 5 times per week. More participants in the Modius Stress arm achieved a 4 point or more reduction in GAD-7 score from baseline to the follow-up visit compared with the sham group (97% [33 out of 34] vs 24% [6 out of 25], respectively). The Modius Stress group had a reduction of 7.44 in GAD-7 score vs a reduction of 2.23 in the sham group (mean difference, -5.21 [95 CI, -6.57, -3.85]; P <.0001).
“GAD affects an estimated 6.8 million adults in the US, over 3% of the population, with women twice as likely to be affected as men, according to the American Depression and Anxiety Association,” said Dr Jason McKeown, CEO of Neurovalens. “Modius Stress is a noninvasive device that treats the underlying issue to improve the lives of patients.”
Note: This article originally appeared on MPR