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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: augmented reality

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Murat Akcakaya, PhD; Phone Number: 412-624-8622; Email: akcakaya@pitt.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Northeastern University
      • Contact: Sarah Ostadabbas, PhD; Phone Number: 617-373-4992; Email: ostadabbas@ece.neu.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • Recruiting
      • University of Pittsburgh
      • Contact: Murat Akcakaya, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: augmented reality

Behavioral: augmented reality; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technology Satisfaction; indicated by a mean score of 3 or higher on the Quebec User Evaluation of Satisfaction with Assistive Technology	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;	week 4
Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire	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;	week 4

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Northeastern University; NSF
• Investigators: Principal Investigator: Murat Akcakaya, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY19060390; 1915083 (Other Grant/Funding Number: NSF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No