Trial design {8}
bossdevice
The study is a multicenter randomized controlled double‐blind three‐arm parallel‐group exploratory clinical trial. Patients and raters in the post‐ and the follow‐up assessment will be blinded to the intervention condition the patient receives. A blinding of the medical doctor and/or study personnel conducting the intervention treatment is not possible, since setting‐up and controlling the intervention treatment requires knowledge of the intervention condition.The study is being conducted as a Medical Device Regulation (MDR) clinical trial. The investigational device (bossdevice, sync2brain GmbH, Tübingen, Germany) is a real‐time digital signal processor that acts as a “brain oscillation state sensor” and consists of hardware and software algorithms. The technology was developed within our group, supported by a transfer of research grant (EXIST) by the German Federal Ministry for Economic Affairs. The device is now being commercialized by a spin-off company, sync2brain GmbH (Tübingen, Germany) under the name “bossdevice”. It is designed to read‐in a real‐time raw data stream from a bio‐signal amplifier (electroencephalography, EEG), to continuously analyze this data and to detect patterns based on oscillations in different frequencies. When such a specific bio‐signal pattern is detected, the device indicates this through a standard output port. This enables a connected device to determine with millisecond accuracy when a specific bio‐signal pattern occurs.