Clinical trial NCT05549453: Use of Nexstim SNBT System
Official title: Use of Nexstim SNBT System in Its Intended Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Usability of the Graphical User Interface of the Device for Its Intended Use
Lead sponsor: Nexstim Ltd
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of usability of the graphical user interface for use of the device in its intended use
timeFrame: Up to 3 months. From subject's enrollment to end of subject's study participation.
Secondary outcomes:
measure: Assessment of usability of the graphical user interface for use for motor cortex localization by device use
timeFrame: Up to 3 months. From subject's enrollment to end of subject's study participation.
measure: Assessment of usability of the graphical user interface for use for motor threshold determination by device use
timeFrame: Up to 3 months. From subject's enrollment to end of subject's study participation.
measure: 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
timeFrame: Up to 3 months. From subject's enrollment to end of subject's study participation.
measure: 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
timeFrame: Up to 3 months. From subject's enrollment to end of subject's study participation.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Nexstim Plc
state: Uusimaa
Study officials:
affiliation: Nexstim Ltd
name: Jarmo T Laine, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: