Visual Stimulation for Stroke Recovery

Overseen By Mahika Rathod

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

Trial Summary

What is the purpose of this trial?

This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.

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 data supports the idea that Visual Stimulation for Stroke Recovery is an effective treatment?

The available research shows that Visual Stimulation for Stroke Recovery can be effective. For example, a study on therapist-assisted vision therapy found improvements in visual performance for stroke patients with visual impairments. Another study on visual restoration therapy indicated that repetitive stimulation could expand visual fields in patients with hemianopia, a condition where half of the visual field is lost. Additionally, a case report on home-based visual rehabilitation using virtual reality showed increased contrast sensitivity, improved visual fields, and enhanced reading speed in patients. These findings suggest that Visual Stimulation for Stroke Recovery can help improve visual abilities and quality of life for stroke patients. ^{1 2 3 4 5}

What safety data exists for Visual Stimulation for Stroke Recovery?

The provided research does not contain safety data for Visual Stimulation for Stroke Recovery or its related terms like Intensive Visual Stimulation Device, IVS, IVS3, or Intensive Visual Stimulation Therapy. The studies focus on intravenous thrombolysis (IVT) for stroke treatment, not visual stimulation therapies. ^{6 7 8 9 10}

Is the Intensive Visual Stimulation Device a promising treatment for stroke recovery?

Yes, the Intensive Visual Stimulation Device is a promising treatment for stroke recovery. It uses virtual reality, which is a fun and engaging way to help stroke patients improve their movement and brain function. This type of therapy can make recovery more effective by encouraging the brain to adapt and improve. ^{3 4 11 12 13}

Research Team

Joan Stilling, MD,MS

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Therapist-assisted vision therapy improves outcome for stroke patients with homonymous hemianopia alone or combined with oculomotor dysfunction. [2018]

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

Lighting as a Compensatory Strategy for Acquired Visual Deficits After Stroke: Two Case Reports. [2019]

3. United States 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. [2022]

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

Brain activity associated with stimulation therapy of the visual borderzone in hemianopic stroke patients. [2022]

5. Switzerland 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. [2021]

6. England 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. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Systemic thrombolysis in patients with acute stroke and active cancer: a systematic review and meta-analysis. [2023]

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

Safety and Efficacy of Intravenous Thrombolytic Therapy in Patients With Acute Posterior Circulation Stroke: A Single-Center Study. [2020]

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

Thrombolysis Versus Nonthrombolyzed in Patients With Mild Strokes and Large Vessel Occlusions: Results of a Multicenter Stroke Registration. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Intravenous Thrombolysis is Effective in Young Adults: Results from the Baden-Wuerttemberg Stroke Registry. [2020]

11. Spain pubmed.ncbi.nlm.nih.gov

[Current evidence on virtual reality and its potential usefulness in post-stroke neurorehabilitation]. [2020]

12. Canada pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality to Improve Outcomes in Veterans With Stroke: Protocol for a Single-Arm Pilot Study. [2021]

13. England 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. [2021]