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

NCT04468919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-05-16

No results posted yet for this 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. (SA3.4) Language model enhancements, including a combination of partner and environmental input and word completion during typing, will improve typing performance with BCI-FIT, as measured by ITR during a story-retell task. Optimized recommendations for a multi-modal BCI for each end user will be established, based on an innovative combination of clinical expertise, user feedback, customized multi-modal sensor fusion, and reinforcement learning.

Conditions

Interventions

BEHAVIORAL

BCI-FIT multi-modal access

Adding a personalized multi-modal access protocol to customize a BCI-FIT access method configuration for each individual end user, based on a combination of user characteristics, clinical expertise, user feedback, and system performance data in the software.

BEHAVIORAL

BCI-FIT adaptive signal modeling

Adding a BCI-FIT adaptive signal modeling that employs transfer learning and on-line model adaptation techniques with noisy labels in the software of this brain-computer interface to eliminate the need for data collection exclusively for model calibration, as well as to address model drift issues associated with drowsiness, fatigue, and other human and environmental factors.

BEHAVIORAL

BCI-FIT active querying

Adding BCI-FIT active querying techniques which are software-based optimal action control policies in the brain-computer interface developed with active and reinforcement learning techniques in order to perform efficient user intent inference to improve the entire speed-accuracy trade-off curve for alternative communication.

BEHAVIORAL

BCI-FIT language modeling

Adding vocabulary and location information (called partner and environmental input) to the language models in the brain-computer interface from a user's communication partner.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Melanie Fried-Oken, PhD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2025-05-05
Completion
2025-05-05

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468919 on ClinicalTrials.gov