Use of Nexstim SNBT System

NCT05549453 | Completed

• 1 other identifier: NX140344
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

SNBT device use

EXPERIMENTAL

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

Interventions

Nexstim SNBT use DEVICE

Active device use

SNBT device use

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-64 years signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Nexstim Ltd: lead

Study Sites (1)

Nexstim Plc

Helsinki, Uusimaa, 00510, Finland

Location

Study Officials

• Jarmo T Laine, MD,PhD

  Nexstim Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 22, 2022
• Study Start: September 26, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)