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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNBT device use | Experimental | SNBT device is used for motor cortex localization, motor threshold determination and for targeting the intracranial electric field induced by the device to the intarcranial location required for the use of the device for its intended use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexstim SNBT use | Device | Active device use |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 3 months. From subject's enrollment to end of subject's study participation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jarmo T Laine, MD,PhD | Nexstim Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nexstim Plc | Helsinki | Uusimaa | 00510 | Finland |
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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.
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yes/no assessment by an expert clinical user of the technology |
| 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 | 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 | Up to 3 months. From subject's enrollment to end of subject's study participation. |