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NCT04468919 · ClinicalTrials.gov registry record · NA

Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit

A NA study, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
55
Enrollment target

NCT04468919: Completed NA study, sponsored by Oregon Health and Science University.

NCT04468919 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04468919, a NA study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
55 participants
Enrollment target

Study Summary

This project adds to non-invasive BCIs for communication for adults with severe speech and physical impairments due to neurodegenerative diseases. Researchers will optimize \& adapt BCI signal acquisition, signal processing, natural language processing, \& clinical implementation. BCI-FIT relies on active inference and transfer learning to customize a completely adaptive intent estimation classifier to each user's multi-modality signals simultaneously. 3 specific aims are: 1. develop \& evaluate methods for on-line \& robust adaptation of multi-modal signal models to infer user intent; 2. develop \& evaluate methods for efficient user intent inference through active querying, and 3. integrate partner \& environment-supported language interaction \& letter/word supplementation as input modality. The same 4 dependent variables are measured in each SA: typing speed, typing accuracy, information transfer rate (ITR), \& user experience (UX) feedback. Four alternating-treatments single case experimental research designs will test hypotheses about optimizing user performance and technology performance for each aim.Tasks include copy-spelling with BCI-FIT to explore the effects of multi-modal access method configurations (SA1.3a), adaptive signal modeling (SA1.3b), \& active querying (SA2.2), and story retell to examine the effects of language model enhancements. Five people with SSPI will be recruited for each study. Control participants will be recruited for experiments in SA2.2 and SA3.4. Study hypotheses are: (SA1.3a) A customized BCI-FIT configuration based on multi-modal input will improve typing accuracy on a copy-spelling task compared to the standard P300 matrix speller. (SA1.3b) Adaptive signal modeling will allow people with SSPI to typing accurately during a copy-spelling task with BCI-FIT without training a new model before each use. (SA2.2) Either of two methods of adaptive querying will improve BCI-FIT typing accuracy for users with mediocre AUC scores. (SA3.

Primary Outcome

Correct character selections divided by the total character selections in a copy spelling task.

Interventions

  • BEHAVIORAL BCI-FIT multi-modal access
  • BEHAVIORAL BCI-FIT adaptive signal modeling
  • BEHAVIORAL BCI-FIT active querying
  • BEHAVIORAL BCI-FIT language modeling

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2022-07-15
Est. Completion 2025-05-05
Phase NA

What the finished NCT04468919 record still lists

NCT04468919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 4 interventions - of which BCI-FIT multi-modal access is the first listed.

NCT04468919 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04468919 about?

NCT04468919 is a clinical study titled "Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit". This project adds to non-invasive BCIs for communication for adults with severe speech and physical impairments due to neurodegenerative diseases. Researchers will optimize \& adapt BCI signal acquisition, signal processing, natural language processing, \& clinical implementation. BCI-FIT relies on ...

What is the current status of trial NCT04468919?

This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2022-07-15. Estimated completion is 2025-05-05.

What interventions are being tested in trial NCT04468919?

The interventions under investigation include: BCI-FIT multi-modal access (BEHAVIORAL), BCI-FIT adaptive signal modeling (BEHAVIORAL), BCI-FIT active querying (BEHAVIORAL), BCI-FIT language modeling (BEHAVIORAL).

Who is sponsoring clinical trial NCT04468919?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04468919's enrollment target sits among peer trials

55 1264th of 2000 higher than 733 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04468919, the US trial registry maintained by the National Library of Medicine. NCT04468919 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.