NCT04187131

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
17mo left

Started Jun 2023

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jun 2023Sep 2027

First Submitted

Initial submission to the registry

December 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
3.5 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

December 2, 2019

Last Update Submit

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

EXPERIMENTAL
Behavioral: augmented reality

Interventions

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.

augmented reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

Northeastern University

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Murat Akcakaya, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Akcakaya, PhD

CONTACT

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

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.

Shared Documents
STUDY PROTOCOL

Locations