Augmented Reality Rehabilitation for Stroke-Related Neglect

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Murat Akcakaya, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Disqualifiers: Dementia, Parkinson's, Multiple sclerosis, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Augmented Reality Rehabilitation for Stroke-Related Neglect?

Research shows that using augmented reality (AR) and electroencephalography (EEG) can help detect and predict visual neglect in stroke patients, suggesting that AR-based treatments like the AREEN System and NAMI App may be effective. Additionally, studies on similar AR and virtual reality therapies have shown improvements in attention and orientation in stroke patients with spatial neglect. ^{1 2 3 4 5}

Is augmented reality rehabilitation safe for humans?

The available research does not provide specific safety data for augmented reality rehabilitation in humans, but it has been used in studies with stroke patients without reported safety concerns. ^{1 2 3 4 5}

How does augmented reality rehabilitation differ from other treatments for stroke-related neglect?

Augmented reality rehabilitation for stroke-related neglect is unique because it uses technology to create an interactive environment that helps patients actively explore and improve their attention and orientation. This approach is different from traditional therapies as it combines visual and motion tracking technologies to engage patients in a more immersive and engaging way, potentially leading to better outcomes. ^{1 2 3 4 6}

Research Team

Murat Akcakaya, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 who've had a stroke and are in inpatient rehab. They must have trouble noticing things on one side (neglect), be able to hear well, respond to vibrations, speak English, and miss targets in an AR test. People with dementia, Parkinson's disease, MS, brain tumors or metal implants that affect EEGs can't join.

Inclusion Criteria

I have had a recent stroke.

English speaking

intact vibration (positive test on Vibration Sensation Test)

Exclusion Criteria

I have been diagnosed with dementia, Parkinson's, multiple sclerosis, or have a brain tumor.

I struggle to follow simple instructions most of the time.

self-report of previous positive photic stimulation test

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Augmented Reality (AR)-based and electroencephalography (EEG)-based neglect detection and rehabilitation tool

4 weeks

Follow-up

Participants are monitored for satisfaction and effectiveness of the AR and EEG-based tool

4 weeks

Treatment Details

Interventions

• Augmented Reality (Behavioral Intervention)

Trial Overview The study is testing a new tool that uses augmented reality (AR) and brainwave monitoring (EEG) to find out if someone has neglect after a stroke and help them recover. Participants will use this AR system as part of their rehabilitation therapy.

Participant Groups

Group I: augmented reality Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Jared Auclair

Northeastern University

Chief Executive Officer

PhD in Biomedical Science from the University of Massachusetts Medical School

Anantdeep Kaur

Northeastern University

Chief Medical Officer since 2023

Master’s and Doctorate in Biotechnology from the University of Technology Sydney

NSF

Collaborator

Trials

1

Recruited

10+

Findings from Research

A new system combining EEG and augmented reality has been developed to effectively identify visual spatial neglect (SN) in stroke survivors, utilizing specific brain wave patterns for detection.

The system demonstrated accuracy in detecting neglected visual targets, suggesting it could be a reliable tool for assessing and mapping visual field neglect in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Stroke-Induced Visual Neglect and Target Response Prediction Using Augmented Reality and Electroencephalography. Mak, J., Kocanaogullari, D., Huang, X., et al.[2023]

The augmented reality app 'Negami' significantly improved spatial neglect in stroke patients, with the Negami group showing better results in 4 out of 5 neglect tests compared to only 1 test improvement in the standard therapy group.

Improvements in the Negami group were evident as early as the first week of training and remained significant even 1-2 months after the treatment, suggesting its potential as a superior alternative to standard neglect therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatial Neglect Therapy With the Augmented Reality App "Negami" for Active Exploration Training: A Randomized Controlled Trial on 20 Stroke Patients With Spatial Neglect. Stammler, B., Flammer, K., Schuster, T., et al.[2023]

The modified computerized visual perception rehabilitation program significantly improved various cognitive and perceptual scores in 16 patients with chronic stroke and unilateral neglect after 4 weeks of training, indicating its efficacy in rehabilitation.

The built-in scoring system allowed for objective assessment of patient progress, enhancing the evaluation of the program's effectiveness compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying and evaluating efficacy of interactive computerized program using motion tracking technology to improve unilateral neglect in patients with chronic stroke. Kang, SH., Kim, DK., Seo, KM., et al.[2022]

The digital health intervention significantly reduced spatially biased attention in patients with chronic hemispatial neglect, as evidenced by improved performance on the Posner cueing task (p=0.010, Cohen's d=0.96).

Participants also showed meaningful improvements in functional abilities, measured by the Catherine Bergego and Barthel indices (p=0.027, Cohen's d=0.24), indicating that the intervention not only helped with attention but also enhanced everyday functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alertness Training Improves Spatial Bias and Functional Ability in Spatial Neglect. Van Vleet, T., Bonato, P., Fabara, E., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Detection of Stroke-Induced Visual Neglect and Target Response Prediction Using Augmented Reality and Electroencephalography. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Spatial Neglect Therapy With the Augmented Reality App "Negami" for Active Exploration Training: A Randomized Controlled Trial on 20 Stroke Patients With Spatial Neglect. [2023]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of virtual reality training on unilateral spatial neglect in stroke patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Modifying and evaluating efficacy of interactive computerized program using motion tracking technology to improve unilateral neglect in patients with chronic stroke. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Alertness Training Improves Spatial Bias and Functional Ability in Spatial Neglect. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Head-Mounted Displays for Upper Limb Stroke Rehabilitation: A Scoping Review. [2023]