StrokeNCT04187131
An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
A study testing augmented reality in people with Stroke, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- augmented reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2023to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Northeastern University
Boston, Massachusetts, 02115
Sarah Ostadabbas, PhD, 617-373-4992, ostadabbas@ece.neu.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Murat Akcakaya, PhD
About this study
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
- Being tested
- augmented reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmented realityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| augmented reality | Experimental | Not described Receives: Behavioral: augmented reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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
Measured: 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
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;
Measured: 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;
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jun 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, NSF
- Responsible party
- Principal investigator, Murat Akcakaya, University of Pittsburgh
- Investigators
- Murat Akcakaya, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187131
- Sponsor's protocol ID
- STUDY19060390
- Other IDs
- 1915083
- Status last verified
- Jul 2026
- First submitted
- 2 Dec 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41773346
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
- ClinicalTrials.gov ID
- NCT04187131
- Acronym / sponsor ID
- STUDY19060390
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Northeastern University, NSF
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| augmented reality | Experimental | Behavioral: augmented reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| augmented realityThe 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. | Behavioural | augmented reality |
Primary outcome
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;
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 41773346Haddadshargh 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murat Akcakaya, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing augmented reality in people with Stroke, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat Akcakaya, PhD (412-624-8622, akcakaya@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect (time frame: week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.