Augmented Reality Rehabilitation for Stroke-Related Neglect

Recruiting at 1 trial location

Overseen By Murat Akcakaya, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool that uses Augmented Reality (AR) to assist individuals who struggle to pay attention to their surroundings after a stroke. The goal is to determine if this AR tool is user-friendly and improves attention. This trial is part of a larger plan to assess whether this technology could serve as a useful treatment in the future. Individuals who have recently experienced a stroke, are in rehabilitation, and have issues with neglect (difficulty noticing things on one side) might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore cutting-edge technology that could enhance the rehabilitation experience.

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 prior data suggests that this augmented reality system is safe for stroke rehabilitation?

Research has shown that using augmented reality (AR) for stroke recovery appears promising and safe. Studies with AR-based tools have found that patients generally handle them well, with no major reports of negative effects. The technology often employs devices like the HoloLens, a headset that provides interactive visuals. These tools have been used safely in other areas, supporting their safety in stroke recovery. In summary, current research suggests that AR treatments are safe and well-received by those using them for stroke rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about augmented reality (AR) for stroke-related neglect because it offers a new way to engage the brain's visual and spatial systems. Unlike traditional rehabilitation methods that rely on physical exercises and tasks, AR immerses patients in interactive, virtual environments that can be tailored to individual needs. This innovative approach could potentially accelerate recovery by making therapy more engaging and adaptable, providing real-time feedback, and encouraging more practice at home. By transforming how patients experience their surroundings, AR has the potential to improve attention and awareness in a way that standard therapies cannot.

What evidence suggests that this augmented reality system is effective for stroke-related neglect?

Studies have shown that augmented reality (AR) can effectively aid stroke rehabilitation, particularly in treating spatial neglect, where individuals struggle to notice things on one side. One study found that an AR app called Negami performed as well as, or even better than, standard therapy for this condition. Another study combined AR with EEG, a test measuring brain activity, to accurately detect neglected stimuli. This trial will evaluate the effectiveness of an AR-based EEG-guided neglect detection system, known as the AREEN System, in enhancing personalized rehabilitation. These early findings suggest that AR-based treatments could offer a promising new approach to help patients recover from stroke-related neglect. ^{1 2 4 6 7}

Who Is on the Research Team?

Murat Akcakaya, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Reality

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.

How Is the Trial Designed?

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+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

NSF

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

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]

Head-Mounted Displays (HMDs) are well-tolerated and show promise in improving upper extremity motor function in chronic stroke survivors, as evidenced by 19 clinical trials reviewed.

The use of HMDs allows for realistic, task-oriented movements that may enhance motor strategies, but the variability in study designs limits conclusions about which specific patient subgroups benefit most from this technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-Mounted Displays for Upper Limb Stroke Rehabilitation: A Scoping Review. Fregna, G., Paoluzzi, C., Baroni, A., et al.[2023]

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]

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 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]

Virtual reality training significantly improved outcomes in the star cancellation test and the Catherine Bergego scale for stroke patients with unilateral spatial neglect, compared to conventional therapy.

The study involved 24 stroke patients over three weeks, indicating that VR training could be a promising therapeutic approach for enhancing recovery in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of virtual reality training on unilateral spatial neglect in stroke patients. Kim, YM., Chun, MH., Yun, GJ., et al.[2022]

Citations

1. inventions.pitt.edu inventions.pitt.edu/technologies/ar-based-eeg-guided--05991

AR-Based EEG-Guided Neglect Detection System for Stroke ... AR-based EEG-guided neglect detection in stroke rehab using HoloLens AR and real-time brain data for accurate, personalized rehabilitation.

2. ieeexplore.ieee.org ieeexplore.ieee.org/ielaam/7333/9695946/9814082-aam.pdf

Detection of Stroke-Induced Visual Neglect and Target ... We have developed a BCI system called AR-based EEG-guided neglect detection system called. AREEN to detect SN and potentially neglected visual targets. Early ...

3. researchgate.net researchgate.net/publication/361778681_Detection_of_Stroke-Induced_Visual_Neglect_and_Target_Response_Prediction_Using_Augmented_Reality_and_Electroencephalography

Detection of Stroke-Induced Visual Neglect and Target ... Additionally, in an augmented reality and EEG system, left occipital alpha power was used to successfully detect neglected stimuli (Mak et al.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37582475/

Spatial Neglect Therapy With the Augmented Reality App ... Conclusion: Negami can be used as an effective alternative or addition to current standard neglect therapy, and may even be superior to it.

5. ui.adsabs.harvard.edu ui.adsabs.harvard.edu/abs/2019nsf....1915083A/abstract

Detection, Assessment and Rehabilitation of Stroke ... The investigators in this project will develop a brain-computer interface (BCI) system that will be implemented in augmented reality (AR) environment for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35786558/

Detection of Stroke-Induced Visual Neglect and Target ... We aim to build a system incorporating electroencephalography (EEG) and augmented reality (AR) that is capable of identifying the presence of visual spatial ...

7. cambridge.org cambridge.org/core/journals/journal-of-the-international-neuropsychological-society/article/using-augmented-reality-to-assess-spatial-neglect-the-free-exploration-test-fet/F53E2ECBC179A46C9332A19916CD17D1

Using augmented reality to assess spatial neglect Post-stroke unilateral spatial neglect: Virtual reality-based navigation and detection tasks reveal lateralized and non-lateralized deficits ...