Usability of the Graphical User Interface of the Device for Its Intended Use
Conditions
Brief summary
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.
Interventions
DEVICENexstim SNBT use
Active device use
Sponsors
Nexstim Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The purpose of the investigation is to assess the usability of the new device user interface in a feasibility study conducted with a prototype device utilizing the new interface in an open label use of the device.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-64 years signed informed consent form
Exclusion criteria
* pregnant implanted electrical device ferromagnetic metal anywhere in the body metal in head except amalgam dental fillings epilepsy migraine previous head trauma or surgery a diagnosed neurological disorder medication affecting the central nervous system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of usability of the graphical user interface for use of the device in its intended use | Up to 3 months. From subject's enrollment to end of subject's study participation. | yes/no assessment by an expert clinical user of the technology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of usability of the graphical user interface for use for motor cortex localization by device use | Up to 3 months. From subject's enrollment to end of subject's study participation. | yes/no assessment by an expert clinical user of the technology |
| Assessment of usability of the graphical user interface for use for motor threshold determination by device use | Up to 3 months. From subject's enrollment to end of subject's study participation. | yes/no assessment by an expert clinical user of the technology |
| 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 | Up to 3 months. From subject's enrollment to end of subject's study participation. | yes/no assessment by an expert clinical user of the technology |
| 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 | Up to 3 months. From subject's enrollment to end of subject's study participation. | yes/no assessment by an expert clinical user of the technology |
Countries
Finland
Outcome results
None listed