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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 10 days training/stimulation and after 6 months training/stimulation
Awards & highlights
Study Summary
This trial is testing a rehabilitation protocol for people with visual field deficit (VFD) caused by damage to the primary visual cortex. The protocol involves visual training with moving stimuli, coupled with transcranial random noise stimulation (tRNS). The trial will test the basic effects of tRNS coupled with visual training in stroke cohorts, including both chronic and subacute VFD stroke participants, and longitudinal testing up to 6 months post-treatment.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I had a stroke that affected my vision.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Motion Discrimination Change
Secondary outcome measures
Quality of Life Change
Visual Field Change
Trial Design
4Treatment 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: 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: 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
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,180 Total Patients Enrolled
Lorella Battelli, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to read.I frequently take medication to prevent severe headaches.You have had problems with drugs or alcohol in the last six months.I don't have chronic conditions like heart issues or asthma that could worsen with a seizure.My doctor will review my medications to decide if I can join the trial.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.My vision problems are due to a stroke that happened after the first one.I have a neurological condition other than stroke, like epilepsy or MS.I do not have any severe, unmanaged, or life-threatening illnesses.You need to show that you have trouble seeing certain things in your visual field when tested with a special machine.You have difficulty paying attention to things on one side of your body, as shown by specific tests.I am completely blind in both eyes.You have difficulty focusing on specific visual targets or following visual training instructions accurately.I have had fainting spells that might be seizures.I cannot undergo tRNS treatment due to health reasons.I am 18 years old or older.I have a history of seizures or epilepsy, except for a single benign seizure.My vision center in the brain is undamaged.The imaging shows that the stroke was caused by bleeding or something other than a blood vessel problem.I have a history of major depression, bipolar, or psychotic disorders.I am not pregnant or breastfeeding.I had a stroke that affected my vision.
Research Study Groups:
This trial has the following groups:- Group 1: Noninvasive Brain Stimulation without visual training
- Group 2: Visual Training with Noninvasive Brain Stimulation
- Group 3: Visual Training with Sham Stimulation
- Group 4: Sham Stimulation without visual training
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are partaking in this research endeavor?
"Affirmative. According to the clinicaltrials.gov website, this investigation is presently recruiting participants, with details being last amended on February 14th 2022 from its original post date of January 25th 2022. 92 individuals are required for enrolment across one medical facility."
Answered by AI
Am I eligible for participation in this clinical investigation?
"Participants that wish to partake in this medical study must have suffered a stroke and be between 18-80 years old. Up to 92 patients can join the trial."
Answered by AI
Can persons aged 35 and above partake in this experiment?
"This clinical trial has established an age range of 18 to 80 for its participants. For those who are below the minimum or above the maximum, there are 64 and 1048 respective trials that younger and older adults may participate in."
Answered by AI
Are there any opportunities to partake in this experiment at the present time?
"Evidently, this medical trial is presently recruiting patients. According to clinicaltrials.gov, the experiment was initially posted on January 25th 2022 and recently updated on February 14th 2022."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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