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Clinical Trials/NCT04187131
NCT04187131RecruitingNot Applicable

An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation

University of Pittsburgh4 sites in 1 country10 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
10
Locations
4
Primary Endpoint
Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect

Study Overview

Brief Summary

The aim of this phase is to examine the feasibility and acceptability of the Augmented Reality (AR)-based and electroencephalography (EEG)-based neglect detection and rehabilitation tool.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ages18 and older
  • acute stroke
  • admitted to inpatient rehabilitation
  • presence of neglect (Behavioral Inattention Test total score <129, or scoring below pre-defined cutoff score in at least one of the six subtests)
  • more than 10/% missed targets on the Augmented Reality Screening Test
  • intact vibration (positive test on Vibration Sensation Test)
  • intact auditory function (positive test on Auditory Sensation Test)
  • English speaking

Exclusion Criteria

  • inability to follow one-step directions at least 80% of the time
  • current diagnosis of dementia, Parkinson's disease, multiple sclerosis, or space-occupying tumor
  • metal in the head that causes interference with the EEG system
  • self-report of previous positive photic stimulation test

Arms & Interventions

augmented reality

Experimental

Intervention: augmented reality (Behavioral)

Outcomes

Primary Outcomes

Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect

Time Frame: week 4

number of sessions attaining greater than 70 percentage agreement between targets identified by the participant and targets identified by EEG; participants view an augmented reality screen with randomly appearing targets in the field of view; when a target is viewed, the participant presses a keyboard key; immediately after, targets randomly appear on the augmented reality screen while the participant's brain activity is recorded by EEG; EEG detects viewed and neglected targets based on brain signals;

Reliability; indicated by correlation coefficient between two consecutive sessions of EEG recording

Time Frame: week 4

number of consecutive sessions attaining Pearson correlation coefficient r greater than.10

Secondary Outcomes

  • Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire(week 4)
  • Technology Satisfaction; indicated by a mean score of 3 or higher on the Quebec User Evaluation of Satisfaction with Assistive Technology(week 4)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Murat Akcakaya

Assistant Professor, Electrical and Computer Engineering

University of Pittsburgh

Study Sites (4)

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