Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
NCT07922265, Not applicable, Not yet recruiting, Universidade Federal do Paraná
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI) | ClinicalTrials.gov |
| NCT number | NCT07922265 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidade Federal do Paraná | ClinicalTrials.gov |
| Conditions | Healthy Volunteers - Male and Female | ClinicalTrials.gov |
| Interventions | EEG-Based Brain-Computer Interface Device | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | EEG Theta/Beta Ratio as a Neurophysiological Marker of Cognitive Load | Measured continuously during each 10-minute experimental block (blocks 1, 2, and 3) throughout the single 35-minute session. | Change in the theta/beta spectral power ratio derived from 6-channel electroencephalography (EEG) recordings during motor imagery (imagined hand movement) tasks. The theta/beta ratio is a validated neurophysiological indicator of cognitive workload and mental effort. This measure is compared across the three distinct device sensitivity levels (low, medium, high) to assess differences in cognitive demand. | ClinicalTrials.gov |
| Secondary | NASA Task Load Index (NASA-TLX) Global Workload Score | Immediately after each sensitivity block (3 times total) during the experimental session. | Subjective assessment of perceived mental workload using the NASA-TLX questionnaire. The instrument evaluates six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. The global workload score ranges from 0 to 100, with higher scores indicating greater perceived workload. | ClinicalTrials.gov |
| Secondary | User Experience Questionnaire (UEQ) Scores | At the end of the entire experimental session. | Assessment of user experience using the standardized User Experience Questionnaire (UEQ). The instrument measures six scales: Attractiveness, Perspicuity, Efficiency, Dependability, Stimulation, and Novelty. Each scale ranges from -3 (very negative) to +3 (very positive), with higher scores indicating a more favorable user experience. | ClinicalTrials.gov |
| Secondary | Qualitative Feedback on BCI Physical Interface and Overall Experience | Immediately following the conclusion of the experimental session. | Thematic content analysis of responses collected through a semi-structured qualitative interview consisting of open-ended questions and visual thematic cards. The analysis captures nuanced perceptions regarding the physical interface (EEG cap and robotic glove), comfort, emotional engagement, usability, and suggestions for device improvement. | ClinicalTrials.gov |
| Secondary | Individual Operational Sensitivity Thresholds | During the calibration phase and across all three experimental blocks within the session. | Identification of the optimal sensitivity level (low, medium, or high) for each participant based on the calibration phase and successful device triggering during motor imagery tasks. This measure assesses how individual neural signal characteristics influence the optimal threshold for reliable BCI operation. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)