60
Participants
Start Date
June 30, 2025
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
Modius Calm
The Modius Calm device is a transdermal neurostimulation product. It consists of a battery-powered headset designed to deliver low-level energy in the form of a neurostimulation waveform that modulates the activity of the vestibular cranial nerve. The active Modius Calm device utilizes a technology called electrical vestibular nerve stimulation (VeNS). In the envisaged configuration the device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current (a maximum of 1.5mA) to the skin behind the ears over the mastoid processes.
Sham device
The sham device is identical in appearance. The Modius Calm sham device follows this pattern by applying some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device.
Lead Sponsor
Neurovalens Ltd.
INDUSTRY