Use of Nexstim SNBT System

Not Applicable

Completed

• Conditions: Usability of the Graphical User Interface of the Device for Its Intended Use
• Interventions: Device: Nexstim SNBT use

• Registration Number: NCT05549453
• Lead Sponsor: Nexstim Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2022-09-26
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SNBT device use	Nexstim SNBT use	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Nexstim Plc; 🇫🇮 Helsinki, Uusimaa, Finland