Usability of the Graphical User Interface of the Device for Its Intended UseNCT05549453
Use of Nexstim SNBT System
A study testing Nexstim SNBT use in people with Usability of the Graphical User Interface of the Device for Its Intended Use, run by Nexstim Ltd at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Usability of the Graphical User Interface of the Device for Its Intended Use
- What is being tested?
- Nexstim SNBT use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 26 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-64 years signed informed consent form
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Nexstim SNBT use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexstim SNBT useDevice
Active device use
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Nexstim SNBT use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
yes/no assessment by an expert clinical user of the technology
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 3 months. From subject's enrollment to end of subject's study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start26 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Usability of the Graphical User Interface of the Device for Its Intended UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nexstim Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jarmo T Laine, MD,PhD, Principal investigator, Nexstim Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549453
- Sponsor's protocol ID
- NX140344
- Status last verified
- Nov 2024
- First submitted
- 14 Sep 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nexstim SNBT System in Its Intended Use
- ClinicalTrials.gov ID
- NCT05549453
- Acronym / sponsor ID
- NX140344
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nexstim LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SNBT device use | Experimental | Device: Nexstim SNBT useSNBT 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-64 years signed informed consent form
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexstim SNBT useActive device use | Device | SNBT device use |
Primary outcome
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
4 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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarmo T Laine, MD,PhD principal investigator
Nexstim Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nexstim SNBT use in people with Usability of the Graphical User Interface of the Device for Its Intended Use, run by Nexstim Ltd at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.