Use of Nexstim SNBT System

Study Overview
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Brief Summary
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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.

Official Title
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Use of Nexstim SNBT System in Its Intended Use

Conditions
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Usability of the Graphical User Interface of the Device for Its Intended Use

Intervention / Treatment
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* Device: Nexstim SNBT use


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNBT device use<br>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 | Device: Nexstim SNBT use<br>* Active device use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |