Use of Nexstim SNBT System

Use of Nexstim SNBT System in Its Intended Use

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Usability of the Graphical User Interface of the Device for Its Intended Use
• Intervention / Treatment: Device: Nexstim SNBT use

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00510
      • Nexstim Plc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SNBT device 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	Device: Nexstim SNBT use; Active device use

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Nexstim Ltd
• Investigators: Principal Investigator: Jarmo T Laine, MD,PhD, Nexstim Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NX140344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No