The clinical investigation assesses the usability of the new graphical user interface of the Nexstim SNBT device in its intended clinical uses. The hardware and the technical functionality of the device of the SNBT device are in other respects similar to those of the earlier Nexstim NBT device, which has been cleared by FDA for treatment of Major Depressive Disorder in 2017 (K170902) and has received EU CE mark for the same and for treatment of chronic neuropathic pain. The present investigation is not intended to establish the safety and efficacy of the SNBT device. Rather, the purpose is to assess the usability of the new user interface in a feasibility study conducted with a prototype device utilizing the new user interface.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
12
Active device use
Nexstim Plc
Helsinki, Uusimaa, Finland
Assessment of usability of the graphical user interface for use of the device in its intended use
yes/no assessment by an expert clinical user of the technology
Time frame: Up to 3 months. From subject's enrollment to end of subject's study participation.
Assessment of usability of the graphical user interface for use for motor cortex localization by device use
yes/no assessment by an expert clinical user of the technology
Time frame: Up to 3 months. From subject's enrollment to end of subject's study participation.
Assessment of usability of the graphical user interface for use for motor threshold determination by device use
yes/no assessment by an expert clinical user of the technology
Time frame: Up to 3 months. From subject's enrollment to end of subject's study participation.
Assessment of usability of the graphical user interface for the targeting of the intracranial electric field generated by the device to the intracranial target location required for the use of the device in its intended use
yes/no assessment by an expert clinical user of the technology
Time frame: Up to 3 months. From subject's enrollment to end of subject's study participation.
Assessment of whether the usability of the graphical user interface is superior to that experienced by the user during his/her previous experience with earlier NBT product generations
yes/no assessment by an expert clinical user of the technology
Time frame: Up to 3 months. From subject's enrollment to end of subject's study participation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.