Use of Nexstim SNBT System

Nexstim

Status: Completed

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

Treatments: Device: Nexstim SNBT use

Study type: Interventional

Funder types: Industry

Identifiers

NCT05549453

NX140344

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SNBT device use

Experimental group

Description:

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

Treatment:

Device: Nexstim SNBT use