Visual Stimulation for Stroke Recovery

Overseen By Zhiyan Yang, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Spasticity, Visual impairments, others

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

Compensation: Varies

Number of Visits: 15

Duration: 4-6 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how an Intensive Visual Stimulation Device can improve arm function and overall satisfaction in individuals who have experienced a stroke. Researchers are testing the device on people with chronic stroke, including those with and without hemi-spatial neglect (difficulty seeing or paying attention to one side). Individuals who had a stroke over six months ago and face moderate challenges using their arm might be suitable candidates. The study seeks to understand if this visual device is easy and comfortable to use in a regular outpatient setting. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance stroke recovery therapies.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Intensive Visual Stimulation Device is safe for stroke recovery?

Research shows that the Intensive Visual Stimulation (IVS3) device is safe for use. Studies have examined how well patients tolerate the device during treatments aimed at improving movement and coordination after a stroke. Notably, one study measured safety by counting serious adverse events during therapy, and no major issues emerged.

This treatment uses visual stimulation to help stroke patients regain better arm movement. While specific side effects aren't detailed in the sources, the absence of serious problems is encouraging. Additionally, virtual reality, a similar technology, has proven effective for related conditions like spatial neglect without major safety concerns. Overall, the IVS3 device appears well-tolerated and safe for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Intensive Visual Stimulation Device because it offers a novel approach to stroke recovery, particularly for those experiencing hemi-spatial neglect. Unlike traditional rehabilitation methods that often rely on physical and occupational therapy, this device uses targeted visual stimulation to engage and potentially rewire the brain's visual processing areas. This method could enhance spatial awareness and improve daily functioning more effectively and quickly. By directly addressing the neural pathways affected by stroke, this treatment approach opens new possibilities for recovery and rehabilitation beyond conventional practices.

What evidence suggests that the Intensive Visual Stimulation Device is effective for stroke recovery?

Research has shown that intense visual exercises can enhance movement and cognitive skills after a stroke. In some studies, patients using video-based visual feedback therapy achieved better arm movement. For individuals with hemi-spatial neglect, virtual reality treatments have led to significant improvements and sometimes near-complete recovery. In this trial, participants will use the Intensive Visual Stimulation Device (IVS3), designed to facilitate recovery through these visual exercises. Early evidence suggests it could be effective, but further studies are necessary to confirm this. ^{1 5 6 7 8}

Who Is on the Research Team?

Joan Stilling, MD,MS

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who had a stroke at least 6 months ago, with moderate upper limb impairments. It's not for those with severe muscle stiffness in the arm, significant vision problems, current pregnancy or incarceration, or if they're getting similar therapy outside the study.

Inclusion Criteria

English speaking

I had a stroke more than 6 months ago.

FMA-UE: 20 < x < 50 (moderate impairments)

Exclusion Criteria

I can communicate effectively and provide informed consent.

My arm is very stiff or has spasms, with a score of 3 or more.

Pregnant or incarcerated individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive intensive visual stimulation (IVS3) for 30 minutes and conventional treatment for 15 minutes across 12 sessions

4-6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Visual Stimulation Device

Trial Overview The trial is testing a device called IVS3 on outpatients who have had a stroke. The goal is to see if using this device helps improve satisfaction and function of the upper limbs (like arms and hands) after chronic stroke.

How Is the Trial Designed?

Group I: Hemi-spatial Neglect Experimental Treatment 1 Intervention

Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests.

Group II: No hemi-spatial neglect Active Control 1 Intervention

Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dessintey Inc.

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The EVREST study is the first randomized trial to evaluate the feasibility, safety, and efficacy of using Nintendo Wii virtual reality technology for arm rehabilitation in stroke patients, involving 21 participants aged 41 to 83 years.

Preliminary results will inform future larger trials, focusing on the effectiveness of VR gaming compared to traditional recreational therapy in improving motor function after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Saposnik, G., Mamdani, M., Bayley, M., et al.[2022]

In a study of 619 patients receiving intravenous thrombolysis (IVT) for acute ischemic stroke with mild neurological deficits, IVT was associated with better functional outcomes compared to 2170 non-IVT patients, showing a higher rate of favorable outcomes (74.6% vs. 70.6%).

The safety profile of IVT was comparable to non-IVT, with similar rates of symptomatic intracranial hemorrhage (2.1% vs. 2.0%) and mortality (0.2% for both groups), indicating that IVT is a safe and effective treatment option for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thrombolysis Versus Nonthrombolyzed in Patients With Mild Strokes and Large Vessel Occlusions: Results of a Multicenter Stroke Registration. Luo, X., Huo, T., Cao, P., et al.[2023]

Therapist-assisted vision therapy over 12 weeks significantly improved visual performance in stroke patients, with 24 participants showing enhanced reading speed and peripheral awareness after training.

Patients reported feeling safer during outdoor activities and traffic, indicating that the therapy not only improved visual skills but also positively impacted their confidence and daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist-assisted vision therapy improves outcome for stroke patients with homonymous hemianopia alone or combined with oculomotor dysfunction. Smaakjær, P., Tødten, ST., Rasmussen, RS.[2018]

A home-based virtual-reality visual rehabilitation program was feasible for two patients with hemianopia due to pediatric brain tumors, with both completing nearly all scheduled sessions (19/20 and 20/20).

The program showed potential effectiveness, as both patients experienced improvements in contrast sensitivity, visual fields, reading speed, and quality of life, particularly notable in case 2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Visual Rehabilitation in Hemianopia Patients. Home-Based Visual Rehabilitation in Patients With Hemianopia Consecutive to Brain Tumor Treatment: Feasibility and Potential Effectiveness. Daibert-Nido, M., Pyatova, Y., Cheung, K., et al.[2021]

RehabMaster™, a virtual reality system designed for post-stroke rehabilitation, was found to be safe and feasible, showing significant improvements in upper extremity function as measured by the Fugl-Meyer Assessment (FMA) and modified Barthel Index (MBI) in a clinical trial with seven chronic stroke patients.

In a randomized controlled trial with 16 acute or subacute stroke patients, adding RehabMaster to conventional occupational therapy showed a trend towards greater improvement in FMA scores, indicating its potential to enhance rehabilitation outcomes, although it did not significantly affect MBI scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A task-specific interactive game-based virtual reality rehabilitation system for patients with stroke: a usability test and two clinical experiments. Shin, JH., Ryu, H., Jang, SH.[2021]

In a study using an ABAB design with two participants in an inpatient rehabilitation facility, enhanced lighting significantly improved grooming performance for individuals with visual deficits due to cerebrovascular accidents (CVAs).

Both participants showed better scores on the Functional Independence Measure (FIM) and reduced time to complete grooming tasks, indicating that personalized lighting interventions can effectively enhance daily functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lighting as a Compensatory Strategy for Acquired Visual Deficits After Stroke: Two Case Reports. Green, M., Barstow, B., Vogtle, L.[2019]

Intravenous thrombolysis (IVT) is shown to be equally effective in young adults aged 18-50 years as in older patients aged 51-80 years, based on an analysis of 4,140 young stroke patients from a large stroke registry in Germany.

The effectiveness of IVT appears to be highest in the youngest subgroup (18-30 years), suggesting that younger patients may benefit even more from this treatment compared to older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Thrombolysis is Effective in Young Adults: Results from the Baden-Wuerttemberg Stroke Registry. Reuter, B., Gumbinger, C., Sauer, T., et al.[2020]

The pilot study aims to assess the feasibility and tolerability of a therapeutic virtual reality (VR) platform in inpatient stroke rehabilitation, focusing on its potential to enhance upper extremity recovery and pain management for veterans over a 4-6 week period.

Preliminary findings suggest that VR interventions could provide effective adjunct therapy in stroke rehabilitation, with the potential for seamless transition from hospital to home, thereby improving patient engagement in self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality to Improve Outcomes in Veterans With Stroke: Protocol for a Single-Arm Pilot Study. Tran, JE., Fowler, CA., Delikat, J., et al.[2021]

A large study involving 56,258 patients across 793 centers found that off-label intravenous thrombolysis (IVT) for acute ischemic stroke is generally safe, particularly for patients with minor strokes, as they showed a lower risk of symptomatic intracranial hemorrhage (SICH).

However, patients with high blood pressure were identified as at higher risk for SICH, indicating that careful individual risk-benefit assessments are necessary when considering off-label IVT treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of symptomatic intracranial haemorrhage in off-label thrombolysis: an analysis of the Safe Implementation of Treatments in Stroke registry. Mundiyanapurath, S., Hees, K., Ahmed, N., et al.[2019]

Intravenous thrombolysis (IVT) for acute ischemic stroke in patients with active cancer does not significantly increase the risk of intracerebral hemorrhage or all-cause mortality, suggesting it is a safe treatment option.

The efficacy of IVT in achieving good functional outcomes (mRS ≤ 2) is comparable between stroke patients with and without active cancer, indicating that IVT can be effectively used in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic thrombolysis in patients with acute stroke and active cancer: a systematic review and meta-analysis. Mosconi, MG., Capponi, A., Paciaroni, M.[2023]

Visual restoration therapy can lead to significant changes in brain activity in hemianopic patients, specifically increasing responsiveness in the trained borderzone of their visual field after one month of therapy, as shown by fMRI results.

The therapy appears to shift attention from the nontrained seeing field to the trained borderzone, with key brain areas like the anterior cingulate and dorsolateral frontal cortex playing a crucial role in this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain activity associated with stimulation therapy of the visual borderzone in hemianopic stroke patients. Marshall, RS., Ferrera, JJ., Barnes, A., et al.[2022]

Intravenous thrombolytic therapy (IVT) using alteplase is shown to be safe and effective for patients with posterior circulation stroke (PCS), with similar recovery outcomes compared to those with anterior circulation stroke (ACS), as evidenced by a study of 462 patients.

In PCS patients, longer time from stroke onset to treatment and occurrences of hemorrhage transformation were identified as significant predictors of poorer outcomes, highlighting the importance of timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Intravenous Thrombolytic Therapy in Patients With Acute Posterior Circulation Stroke: A Single-Center Study. Zhu, X., Wang, N., Lin, H., et al.[2020]

Virtual reality therapy (VRT) has been shown to safely enhance motor and functional recovery in stroke patients, improving upper limb function, gait, balance, and quality of life when used alongside conventional therapy.

While VRT demonstrates significant benefits, it does not show clear superiority over traditional rehabilitation methods, indicating a need for further research to identify which patients respond best to this therapy and to establish optimal treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current evidence on virtual reality and its potential usefulness in post-stroke neurorehabilitation]. León-Ruiz, M., Pérez-Nieves, MT., Arce-Arce, S., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06483230

Implementation of IVS3 for Upper Limb Motor Recovery This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11445588/

A FEASIBILITY AND PROOF-OF-CONCEPT STUDY - PMC This study assessed the effectiveness of a video-based visual feedback therapy synchronized with a coherent motor imagery task (Intensive Visual Simulation) in ...

3. withpower.com withpower.com/trial/phase-myocardial-infarction-8-2024-e7c09

Visual Stimulation for Stroke Recovery This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device.

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1142663/full

Feasibility of hemispatial neglect rehabilitation with virtual ... Hemispatial neglect (HSN) manifests as slow, incomplete, or a lack of responses to stimuli presented in the area of the visual field ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149763423002178

Virtual reality rehabilitation for unilateral spatial neglect Results showed improvement in motor and cognitive performance after training and almost complete resolution of neglect symptoms, especially with the S-IVT ...

6. trialx.com trialx.com/clinical-trials/listings/320129/implementation-of-ivs3-for-upper-limb-motor-recovery/

Implementation of IVS3 for Upper Limb Motor Recovery Overview. This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8297561/

Robot-Assisted Arm Training in Stroke Individuals With ... The study was aimed to investigate the effects of RAT on unilateral spatial neglect, arm motor function, activities of daily living, and social participation ...

8. trial.medpath.com trial.medpath.com/clinical-trial/578ec1de124c5f22/nct06483230-pilot-study-visual-stimulation-upper-limb-recovery

Implementation of IVS3 for Upper Limb Motor Recovery 12 treatment sessions over 4-6 weeks. The primary outcome for safety is defined as the number of serious adverse events that occur while using the IVS3 device.