An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
2 other identifiers
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jun 2023
Longer than P75 for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
July 11, 2025
July 1, 2025
3.3 years
December 2, 2019
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect
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;
week 4
Reliability; indicated by correlation coefficient between two consecutive sessions of EEG recording
number of consecutive sessions attaining Pearson correlation coefficient r greater than.10
week 4
Secondary Outcomes (2)
Technology Satisfaction; indicated by a mean score of 3 or higher on the Quebec User Evaluation of Satisfaction with Assistive Technology
week 4
Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire
week 4
Study Arms (1)
augmented reality
EXPERIMENTALInterventions
The participants will be wearing an EEG cap and Augmented Reality headset (AR-based EEG-guided system) for 10 sessions with a licensed occupational therapist, provided in addition to usual rehabilitation care (either in inpatient rehabilitation or at home). These sessions will focus on activities of daily living that the participants want to practice. All sessions will last approximately 1 hour. These sessions will be scheduled around the existing therapy schedule to cause the least amount of interference with planned clinical activities.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Northeastern Universitycollaborator
- NSFcollaborator
Study Sites (2)
Northeastern University
Boston, Massachusetts, 02115, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murat Akcakaya, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Electrical and Computer Engineering
Study Record Dates
First Submitted
December 2, 2019
First Posted
December 5, 2019
Study Start
June 1, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2027
Last Updated
July 11, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Recorded EEG data may be disseminated to collaborators, other researchers, or the general public, for instance via DScholarship@Pitt: University of Pittsburgh Institutional Repository or through Pitt Box. At this time, there are no specific external parties. If in the future, access to data is requested, any identifying data to will be removed from the EEG data to protect participants' privacy.