Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT04187131

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

augmented reality

Study Details

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.

Conditions

Stroke

Study ID

NCT04187131

Start date

Jun 1, 2023

Status verified date

Jul, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: augmented reality

Interventions

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.

Primary outcome measure

  • Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect [ Time Frame: week 4 ]
  • Reliability; indicated by correlation coefficient between two consecutive sessions of EEG recording [ Time Frame: week 4 ]

Central Contacts and Locations

Central contacts

Murat Akcakaya, PhD

412-624-8622akcakaya@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-13.