Learning Study: Improving Vision in Adults With Macular Degeneration
NCT ID: NCT04762368
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-02-13
2026-12-31
Brief Summary
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In addition, secondary measures of visual acuity will also be examined to determine whether brain stimulation can allow patients to resolve finer details of an image. The proposed treatment is the application of a-tDCS onto the participant's head, with brain stimulation aimed at Primary Visual Cortex toward the occipital pole, while patients undergo six separate sessions of training. The investigators will test the ability of participants to read words before the start of the training sessions (pre test) and after the completion of all training sessions (post test). This is a between-subjects design, and half of the participants will receive true stimulation, and the other half will receive sham stimulation. The difference between the pre and post tests when receiving active stimulation will be compared to the difference when receiving sham stimulation, because the sham stimulation is not expected to influence reading beyond a placebo. The aim of the study is to examine the potential of concurrent brain stimulation and perceptual learning as an effective treatment for macular degeneration that may be used in conjunction with more traditional eye-based interventions. The investigators hypothesize that the brain stimulation will enable higher performance in the reading task after and secondary measures after perceptual training due to an increase in the cortical excitability of the stimulated brain cells.
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Detailed Description
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Participants will be recruited from university-affiliated clinics and local clinical practices. Following full informed consent, participants will complete baseline testing and clinical testing to confirm that they meet eligibility criteria including: a diagnosis of macular degeneration without any additional eye disease, impaired vision but with enough visual acuity that the computer monitor can still present readable word, and no contraindications for brain stimulation interventions. Eligible participants will then be randomized to either receiving the active stimulation during perceptual training or the placebo stimulation during perceptual training.
The primary outcome measure is verbal reading accuracy for sentences presented on a computer screen following a Rapid Serial Visual Presentation (RSVP) task in which a single word is presented on the screen at a time. Participants will freely observe the words and will indicate the words on the screen verbally. The secondary outcome measures are contrast sensitivity and crowded and uncrowded visual acuity as measured by Freiburg Visual Acuity \& Contrast Test (FrACT) using the Landolt C stimulus. The "C"'s gap will be oriented randomly, and the participant will indicate the orientation of the stimulus. Crowded visual acuity will be assessed with Landolt C surrounded by a solid ring, while uncrowded visual acuity will be assessed with the Landolt C alone. The Test of contrast sensitivity will measure the amount of contrast required relative to the background to identify the orientation of the "C". The Hong Kong Polytechnic University has an additional set of secondary outcome measures of temporal and spatial visual span. Temporal visual span will be assessed using Chinese trigrams presented horizontally or vertically at the centre for a range of presentation times. Spatial visual span will be assessed using Chinese trigrams presented horizontally or vertically at different character positions for a fixed presentation time. Participants will be asked to recognize all three characters in a correct order.
The study consists of 9 sessions plus 1 additional session particularly for Hong Kong Polytechnic University
Session 0: This session only applies for The Hong Kong Polytechnic university, that horizontal and vertical temporal and spatial visual span will be collected.
Session 1: The first session will include the clinical evaluation. In addition, the pre tests of all outcome measures will be collected (RSVP performance, crowded and uncrowded visual acuity, contrast sensitivity).
Sessions 2-7: Brain stimulation sessions. Participants will undergo roughly 1 hour of perceptual training, performing the RSVP task. The first 25 minutes of this training will include either sham or active brain stimulation. A given participant will receive the same kind of stimulation for all 6 training sessions.
Session 8: No brain stimulation will occur. Post test outcome measures will be collected (RSVP performance, crowded and uncrowded visual acuity, contrast sensitivity, horizontal and vertical temporal and spatial visual span).
Session 9: 30 day follow up. 30 days after the final training session, participants will again perform the outcome measures without brain stimulation to determine the long term benefit of the perceptual training + brain stimulation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active + Training
Participants in this arm will be exposed to active stimulation for the first 25 minutes of a roughly hour - long perceptual training procedure in which participants must verbally read sentences presented at various speeds and sizes.
Active anodal tDCS
a weak electric current is applied to the head through electrodes to affect the cortical excitability of the targeted cells in the brain.
Sham + Training
Participants in this arm will be exposed to sham stimulation for the first 25 minutes of a roughly hour - long perceptual training procedure in which participants must verbally read sentences presented at various speeds and sizes.
Sham anodal tDCS
The tDCS machine will be used as in active stimulation, except the electrical current will not be applied.
Interventions
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Active anodal tDCS
a weak electric current is applied to the head through electrodes to affect the cortical excitability of the targeted cells in the brain.
Sham anodal tDCS
The tDCS machine will be used as in active stimulation, except the electrical current will not be applied.
Eligibility Criteria
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Inclusion Criteria
2. Visual acuity (VA); between 6/9-6/96 in the better eye
3. Best-corrected near visual acuity of 4.0M at 40 cm or better in the better eye
4. Stable vision in previous 3 months (patient report)
5. Central vision loss
Exclusion Criteria
2. Not fluent in reading English (Waterloo) or Chinese characters (Hong Kong).
3. Any ocular surgery (including anti-vegF injections) within the duration of the study, except for: A. Chronic and continuous injections for at least 1 year. B. Injections stopped at least 2 months before participation. C. Injections in the untested eye
4. Ocular pathology other than JMD or AMD that can significantly reduce central vision. Example: mild cataract of grade 2 or below is acceptable
5. Severe hearing impairment.
6. Contraindications for brain stimulation
18 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
University of Waterloo
OTHER
Responsible Party
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Ben Thompson
Professor; Associate Director for Research
Principal Investigators
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Ben Thompson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Waterloo
Locations
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University of Waterloo
Waterloo, Ontario, Canada
The Hong Kong Polytechnic University
Hung Hom, Kowloon, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VSBrainStim2
Identifier Type: -
Identifier Source: org_study_id
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