Recruiting NCT04187131
An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: augmented reality.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 in
Primary outcome measures
- 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]
Secondary outcome measures (2)
- 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]
- Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire [Time frame: week 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Northeastern University — Boston
- University of Pittsburgh — Pittsburgh
Publications
- Haddadshargh G, Gall R, Grattan ES, Ostadabbas S, Wittenberg GF, Akcakaya M. Brain Network Connectivity During Resting-State and a Visuospatial Task as a Biomarker for Spatial Neglect in Stroke Patients. Neurorehabil Neural Repair. 2026 Jun;40(6):482-494. doi: 10.1177/15459683261419423. Epub 2026 Mar 3. PMID 41773346
Identifiers
NCT: NCT04187131 · STUDY19060390 · 1915083