What side effects are associated with this type of intervention?

Common treatments for visual impairment involving neuromodulation, such as Transcranial Random Noise Stimulation (tRNS) coupled with visual training, generally aim to promote neural plasticity and recovery of visual abilities. Known side effects of similar neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS), include mild and transient discomfort at the stimulation site, headaches, and in rare cases, seizures. These treatments are generally well-tolerated, with no serious adverse events reported in most studies.

What prior FDA approvals exist?

There are no specific FDA approvals for Transcranial Random Noise Stimulation (tRNS) for visual impairment. However, related treatments such as Transcranial Magnetic Stimulation (TMS) have been explored for various neurological conditions, including visual field deficits. TMS has shown promise in improving visual function by stimulating the visual cortex, promoting neural plasticity, and aiding recovery. These treatments are still largely experimental and are not yet standard clinical practice for visual impairment.

What other types of research exist?

Promising alternatives to tRNS coupled with visual training for visual impairment patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown efficacy in enhancing neurocognition and promoting recovery in various neurological conditions. 2) Deep Transcranial Magnetic Stimulation (dTMS), which has been associated with reduced depressive relapses and could potentially aid in visual recovery. 3) Low Field Magnetic Stimulation (LFMS), noted for its rapid mood-elevating effects, which might be adapted for visual rehabilitation. These methods leverage neuromodulation to promote neural plasticity and could be considered for treatment in 2024.

← Back to Search

Brain Stimulation + Visual Training for Stroke-Related Vision Impairment

N/A

Recruiting

Led By Lorella Battelli, PhD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

First ever ischemic stroke with damage to primary visual cortex, and rendered blind over a portion of their visual field.

Must not have

Current history of poorly controlled migraines including chronic medication for migraine prevention

Visual cortex damage a result of a subsequent stroke (not primary)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 10 days training/stimulation and after 6 months training/stimulation

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of transcranial random noise stimulation may include discomfort at the electrode site on the scalp, headache, fatigue after sessions or rarely seizures. Side effects vary among individuals based on personal health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I had a stroke that affected my vision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I frequently take medication to prevent severe headaches.

Select...

My vision problems are due to a stroke that happened after the first one.

Select...

I have a neurological condition other than stroke, like epilepsy or MS.

Select...

I do not have any severe, unmanaged, or life-threatening illnesses.

Select...

I am completely blind in both eyes.

Select...

I cannot undergo tRNS treatment due to health reasons.

Select...

My vision center in the brain is undamaged.

Select...

I have a history of major depression, bipolar, or psychotic disorders.

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 10 days training/stimulation and after 6 months training/stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 10 days training/stimulation and after 6 months training/stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 10 days training/stimulation and after 6 months training/stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Motion Discrimination Change

Secondary study objectives

Quality of Life Change

Visual Field Change

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Visual Training with Sham StimulationExperimental Treatment2 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 StimulationExperimental Treatment2 Interventions

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

Group III: Noninvasive Brain Stimulation without visual trainingExperimental Treatment1 Intervention

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

Group IV: Computer Visual Training with Noninvasive Brain StimulationExperimental Treatment2 Interventions

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

Group V: Sham Stimulation without visual trainingPlacebo Group1 Intervention

Placebo control. Simulation of tRNS without receiving any actual stimulation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sham stimulation

2006

Completed Phase 3

~1040

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for visual impairment, particularly those involving noninvasive brain stimulation like Transcranial Random Noise Stimulation (tRNS), work by promoting neural plasticity and recovery of visual abilities. tRNS, when coupled with visual training, stimulates the visual cortex, enhancing the brain's ability to reorganize and form new neural connections. This is crucial for patients with visual impairment as it can lead to significant improvements in visual function, aiding in the recovery of lost visual abilities and improving overall quality of life.

High-frequency TRNS reduces BOLD activity during visuomotor learning.