Brain Stimulation + Visual Training for Stroke-Related Vision Impairment

Overseen By Meghna Uzgare, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: CNS active drugs

Disqualifiers: Epilepsy, Major depression, Substance abuse, others

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

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people recover vision lost due to a stroke by testing whether combining brain stimulation with visual training can improve sight in the affected areas. Participants will try various methods, including computer and virtual reality-based visual training, to determine if these approaches accelerate recovery. Individuals with vision problems from a stroke, who still have some intact brain areas that process sight, might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance recovery and improve quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, your medications will be reviewed by a doctor, and a decision will be made based on your medical history and current treatment.

What prior data suggests that this rehabilitation protocol is safe for stroke-related vision impairment?

Research shows that computer-based visual training is safe for stroke patients. Studies indicate that patients using these systems often feel motivated and do not experience major side effects. This training effectively helps patients regain vision after a stroke.

Research suggests that transcranial random noise stimulation (tRNS) is generally well-tolerated. A review of non-invasive brain stimulation methods found them safe, with few reports of serious side effects. Most patients handle tRNS without significant problems.

Both treatments have shown promise in helping stroke patients with vision issues. Participants report minimal adverse effects, making these treatments a potentially safe option for those considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stroke-related vision impairment because they combine noninvasive brain stimulation with visual training, offering a fresh approach to rehabilitation. Unlike traditional therapies that might rely on vision exercises alone, this treatment uses transcranial random noise stimulation (tRNS) to potentially enhance brain plasticity and improve visual outcomes. The use of tRNS is relatively novel in this context and could accelerate progress compared to standard therapies. Additionally, the treatments vary in their approach, with some incorporating virtual reality, which could further engage patients and improve adherence. Overall, these innovative combinations aim to offer faster and possibly more effective recovery options for patients with vision impairments after a stroke.

What evidence suggests that this trial's treatments could be effective for stroke-related vision impairment?

Research has shown that virtual reality (VR) and computer-based visual training can improve vision in stroke patients who have lost some sight. Studies have found that adding VR to regular therapy can enhance recovery outcomes, particularly in skills like balance and movement, which also aid vision recovery.

In this trial, participants will be assigned to different treatment arms. One arm will receive Computer Visual Training with Noninvasive Brain Stimulation, while another will receive VR Visual Training with Noninvasive Brain Stimulation. Additional arms include Noninvasive Brain Stimulation without visual training and Visual Training with Sham Stimulation.

For non-invasive brain stimulation, transcranial random noise stimulation (tRNS) shows promise in boosting brain function. Some studies suggest that tRNS can improve vision after a stroke, although more research is needed to fully understand its impact. Combining tRNS with visual training might enhance effectiveness, potentially leading to quicker and better vision recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Lorella Battelli

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had their first ischemic stroke causing partial blindness due to damage in the primary visual cortex. They must have some intact visual areas, show a deficit in visual perception, and be able to follow the study protocol. Exclusions include hemorrhagic stroke, multiple strokes, complete reading loss, severe psychiatric conditions, attentional neglect, contraindications for tRNS treatment or pregnancy.

Inclusion Criteria

You have some parts of your brain related to vision that are still working, except for the main visual area. This will be checked with MRI or CT scans provided by your neurologist.

You need to show that you have trouble seeing certain things in your visual field when tested with a special machine.

Willing and able to participate in the study protocol and to comply with study procedures

Exclusion Criteria

A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig)

You are unable to read.

I frequently take medication to prevent severe headaches.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10 daily sessions of tRNS with or without visual training, depending on the group assignment

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in visual field and quality of life after treatment

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Computer Based Visual Training
• Sham stimulation
• tRNS

Trial Overview

The study tests if noninvasive brain stimulation (tRNS) combined with computer-based visual training can improve vision deficits caused by cortical lesions from a stroke. Group 1 receives both tRNS and training; Group 2 gets only tRNS. The effects are measured immediately and up to six months post-treatment.

How Is the Trial Designed?

Group I: Visual Training with Sham Stimulation Experimental Treatment 2 Interventions

10 daily (Monday-Friday) 20-30 minute sessions of sham stimulation with visual training on the computer

Group II: VR Visual Training with Noninvasive Brain Stimulation Experimental Treatment 2 Interventions

10 daily (Monday-Friday) 20-30 minute sessions of tRNS with visual training on the computer

Group III: Noninvasive Brain Stimulation without visual training Experimental Treatment 1 Intervention

10 daily (Monday-Friday) 20-30 minute sessions of tRNS alone

Group IV: Computer Visual Training with Noninvasive Brain Stimulation Experimental Treatment 2 Interventions

10 daily (Monday-Friday) 20-30 minute sessions of tRNS with visual training on the computer

Group V: Sham Stimulation without visual training Placebo Group 1 Intervention

Placebo control. Simulation of tRNS without receiving any actual stimulation

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

Non-invasive stimulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial electrical stimulation (tDCS/tACS), have shown promise in modulating visual processing and restoring visual functions in patients with conditions like glaucoma and amblyopia, based on a review of their effects on both normal and damaged visual systems.

While these stimulation methods have demonstrated better responses than sham treatments in clinical studies, the variability in patient responses highlights the need for further research to understand their mechanisms of action and to personalize treatment protocols for improved efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision modulation, plasticity and restoration using non-invasive brain stimulation - An IFCN-sponsored review. Sabel, BA., Thut, G., Haueisen, J., et al.[2021]

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 4-week virtual-reality audiovisual rehabilitation program significantly improved visual perception, contrast sensitivity, and fixation stability in a 15-year-old patient with right homonymous hemianopia, enhancing his quality of life.

This study demonstrates that remote-controlled virtual-reality therapy can effectively provide low-vision rehabilitation at home, challenging the notion that vision loss after injury is permanent and unchangeable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Audiovisual 3D-Immersive Stimulation Program in Hemianopia Using a Connected Device. Daibert-Nido, M., Pyatova, Y., Cheung, KG., et al.[2021]

A combination of just 10 days of visual training and transcranial random noise stimulation (tRNS) significantly improved visual motion perception in both neurotypical individuals and patients with chronic cortical blindness, with effects lasting up to 6 months after training.

This approach not only accelerated the learning process, making it at least twice as fast compared to traditional methods, but also demonstrated the potential to restore visual abilities in patients with previously untreatable conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boosting Learning Efficacy with Noninvasive Brain Stimulation in Intact and Brain-Damaged Humans. Herpich, F., Melnick, MD., Agosta, S., et al.[2020]

A visual training program for seven participants with occipital lobe damage led to significant improvements in visual tasks, with an average increase of 9.6% in Gabor detection and 9.9% in direction discrimination after 3-6 months of training.

Neuroimaging revealed that these improvements were associated with increased activity in the motion area V5/hMT of the brain, suggesting that targeted training can enhance visual function even in areas of the visual field that were previously considered permanently damaged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Visual Sensitivity and Occipital Activity in Patients With Hemianopia Following Vision Rehabilitation. Ajina, S., Jünemann, K., Sahraie, A., et al.[2022]

In a study involving 61 participants, high-definition transcranial random noise stimulation (tRNS) was found to significantly enhance long-term performance and retention in a complex video game task compared to simple-definition tRNS and sham stimulation.

This research suggests that high-definition tRNS may be a more effective method for improving cognitive abilities and learning rates in complex tasks, marking a step forward in understanding the optimal electrode montages for neuromodulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance after training in a complex cognitive task is enhanced by high-definition transcranial random noise stimulation. Chenot, Q., Hamery, C., Lepron, E., et al.[2022]

In a study involving 19 adults with amblyopia, five days of transcranial random noise stimulation (tRNS) significantly improved contrast sensitivity and uncrowded visual acuity in the amblyopic eye, while sham stimulation showed no effects.

Although initial improvements were noted on the first day of stimulation, the benefits did not persist across multiple sessions, except for a lasting enhancement in uncrowded visual acuity observed at a 28-day follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive visual cortex transcranial random noise stimulation in adults with amblyopia. Donkor, R., Silva, AE., Teske, C., et al.[2021]

Random noise stimulation, which uses unpredictable energy forms like electrical or mechanical stimuli, has shown promise in enhancing sensory, motor, and cognitive functions, particularly through techniques like transcranial random noise stimulation.

This technique has potential applications in treating various neurological disorders, including ADHD, schizophrenia, and post-stroke recovery, but further randomized controlled trials are needed to optimize its effectiveness and validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Random noise stimulation in the treatment of patients with neurological disorders. Herrera-Murillo, MA., Treviño, M., Manjarrez, E.[2022]

In a pilot study involving 12 participants (8 analyzed), combining transcranial direct current stimulation (tDCS) with Vision Restoration Therapy (VRT) led to significantly greater improvements in visual field expansion and activities of daily living compared to VRT alone.

The results suggest that tDCS may enhance the brain's plasticity mechanisms during visual rehabilitation, although subjective perceptions of visual changes were unexpectedly greater in the VRT and sham group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of visual field training for hemianopia with active versus sham transcranial direct cortical stimulation. Plow, EB., Obretenova, SN., Fregni, F., et al.[2012]

Transcranial random noise stimulation (tRNS) applied to the auditory cortex significantly increased auditory steady state responses (ASSRs) in healthy subjects, indicating enhanced excitability of the auditory cortex.

The study involved 14 participants in a placebo-controlled design, and while there was a notable increase in ASSR at 40 Hz, changes in resting state theta band power were not statistically significant, suggesting tRNS may selectively enhance certain auditory processing functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. Van Doren, J., Langguth, B., Schecklmann, M.[2022]

Transcranial random noise stimulation (tRNS) is a non-invasive method that can effectively modulate perception and enhance learning in individuals, indicating its potential as a therapeutic tool.

While tRNS shows promise for improving brain function, its effects on higher cognitive processes are inconsistent, suggesting that further research is needed to understand its long-term benefits and mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. van der Groen, O., Potok, W., Wenderoth, N., et al.[2022]

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