NCT05549453

Use of Nexstim SNBT System

Use of Nexstim SNBT System in Its Intended Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Nexstim Ltd · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Nexstim SNBT use	Active device use

Timeline

• Start date: 2022-09-26
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2022-09-22
• Last updated: 2024-11-18

Locations

1 site across 1 country: Finland