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NCT Number: NCT04187131

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeastern University, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented Reality

Behavioral

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.

Primary outcomes

  1. 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;

  2. 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

  1. Technology Satisfaction; indicated by a mean score of 3 or higher on the Quebec User Evaluation of Satisfaction with Assistive Technology

    Time frame: week 4

    number of participants attaining greater than or equal to 90 percentage satisfaction; satisfaction is rated on 12 items with a 5-point likert scale, 5 indicating very high satisfaction; items are summed with total a total score of 60 indicating very high satisfaction;

  2. Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire

    Time frame: week 4

    number of participants attaining greater than or equal to 90 percentage satisfaction; satisfaction is rated on 8 items with a 4-point likert scale, 4 indicating very high satisfaction; items are summed with total a total score of 32 indicating very high satisfaction;

Study contacts

Contact information is provided by the study sponsor or research team.

Murat Akcakaya, PhD

CONTACT

[email protected]

412-624-8622

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • NSF
  • Northeastern University

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Dec 5, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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