Brain Stimulation + Visual Training for Stroke-Related Vision Impairment

Overseen by Lorella Battelli

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: CNS active drugs

Disqualifiers: Epilepsy, Major depression, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for stroke patients who have lost part of their vision. The treatment combines visual exercises with gentle electrical brain stimulation to help improve vision. The goal is to see if this approach can help the brain recover and restore some lost vision.

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 data supports the effectiveness of the treatment Brain Stimulation + Visual Training for Stroke-Related Vision Impairment?

Research shows that transcranial random noise stimulation (tRNS) can improve visual functions like contrast sensitivity and visual acuity in conditions like amblyopia, and virtual reality visual training has shown potential in improving visual perception and quality of life in patients with visual field loss. These findings suggest that similar techniques might help with stroke-related vision impairment. ^{1 2 3 4 5}

Is transcranial random noise stimulation (tRNS) safe for humans?

Transcranial random noise stimulation (tRNS) is generally considered safe for humans, as it is a non-invasive technique used in various studies to improve sensory, motor, and cognitive functions without significant adverse effects reported. ^{1 2 6 7 8}

How does the treatment of Brain Stimulation + Visual Training for Stroke-Related Vision Impairment differ from other treatments?

This treatment is unique because it combines computer-based visual training with transcranial random noise stimulation (tRNS), which enhances learning and recovery of visual functions more quickly and effectively than visual training alone. Unlike traditional methods that may take months, this approach can lead to significant improvements in just 10 days, with effects lasting up to 6 months. ^{5 9 10 11 12}

Research Team

Lorella Battelli

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Computer Based Visual Training (Behavioural Intervention)
• Sham stimulation (Procedure)
• tRNS (Noninvasive Brain Stimulation)

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.

Participant Groups

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+

Dr. Kevin Tabb

Beth Israel Deaconess Medical Center

Chief Executive Officer since 2021

MD from Hebrew University Hadassah Medical School

Dr. Chi Chang Daniel Siao

Beth Israel Deaconess Medical Center

Chief Medical Officer since 2023

MD from King George’s Medical University

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

Repetitive visual cortex transcranial random noise stimulation in adults with amblyopia. [2021]

2. India pubmed.ncbi.nlm.nih.gov

Random noise stimulation in the treatment of patients with neurological disorders. [2022]

3. 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]

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

An Audiovisual 3D-Immersive Stimulation Program in Hemianopia Using a Connected Device. [2021]

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

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

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

Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. [2022]

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

Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Performance after training in a complex cognitive task is enhanced by high-definition transcranial random noise stimulation. [2022]

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

Comparison of visual field training for hemianopia with active versus sham transcranial direct cortical stimulation. [2012]

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

Increased Visual Sensitivity and Occipital Activity in Patients With Hemianopia Following Vision Rehabilitation. [2022]

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

Boosting Learning Efficacy with Noninvasive Brain Stimulation in Intact and Brain-Damaged Humans. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Vision modulation, plasticity and restoration using non-invasive brain stimulation - An IFCN-sponsored review. [2021]