Nexstim Plc
Helsinki, Uusimaa, 00510, Finland
Completed
NCT Number: NCT05549453
Use of Nexstim SNBT System
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.
Completed
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Notify MeKey information
Age range
18 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Nexstim SNBT use
DeviceActive device use
Primary outcomes
-
Assessment of usability of the graphical user interface for use of the device in its intended use
Time frame: 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 outcomes
-
Assessment of usability of the graphical user interface for use for motor cortex localization by device use
Time frame: 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 threshold determination by device use
Time frame: 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
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
Nexstim Ltd
Industry
Registry information
Official study title
Use of Nexstim SNBT System in Its Intended Use
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2023
- First posted
- Sep 22, 2022
- Registry last updated
- Nov 18, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.