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Clinical Trial

Clinical Outcome Assessment for AT & BCI

NCT: NCT07407725 · RECRUITING

NCT IDNCT07407725
StatusRECRUITING
Start Date2026-01-08
Completion2027-06

Brief Summary

Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools. This project seeks to address this gap by developing a standardized method to objectively assess or compare the functional benefit of these tools on digital independence, i.e., the ability to independently operate computers, phones, and other digital systems, by creating a unique Digital Assessment Interface (DAI). This assessment will be a simulation of online and digital activities that prior work has determined is important to functional daily living in the digital domain. Participants will complete this assessment with various ATs and BCIs, and these scores will be used to create an index, which will be comprised of performance outcomes, clinician-reported outcomes, and patient-reported outcomes. The tool aims to quantify and compare digital task performance across devices and user populations. The primary objective of this study is to develop an index. The index will quantify functional performance of individuals using various ATs and BCIs. The secondary objectives are to extensively evaluate the psychometric properties of the index, such as the validity, responsiveness, reliability, and floor/ceiling effects both globally and across different devices and impairment levels, ensuring that it can reliably measure the impact of an AT or BCI on a user's ability to independently operate digital systems; and to characterize the familiarization and use of specific BCI and AT systems with reference to a normative healthy control population.

Frequently Asked Questions

What is Clinical Outcome Assessment for AT & BCI?

Clinical Outcome Assessment for AT & BCI is a clinical trial registered under NCT07407725. Current status: RECRUITING.

What is the status of NCT07407725?

The current status of NCT07407725 (Clinical Outcome Assessment for AT & BCI) is: RECRUITING.

When did Clinical Outcome Assessment for AT & BCI start?

Clinical Outcome Assessment for AT & BCI started on 2026-01-08.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.