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Macular DegenerationNCT04762368

Learning Study: Improving Vision in Adults With Macular Degeneration

A study testing Active anodal tDCS in people with Macular Degeneration, run by University of Waterloo at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to test whether a kind of brain stimulation called anodal transcranial direct current stimulation (a-tDCS) can be combined with perceptual learning to improve the ability of people with age-related macular degeneration (AMD) or juvenile macular degeneration (JMD) to read words presented to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Active anodal tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesin 2 countries
Study dates
13 Feb 2021to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of AMD (age 60+) or JMD (current age 18+).
  • Visual acuity (VA); between 6/9-6/96 in the better eye
  • Best-corrected near visual acuity of 4.0M at 40 cm or better in the better eye
  • Stable vision in previous 3 months (patient report)
  • Central vision loss

Who cannot join

  • Diagnosed dementia.
  • Not fluent in reading English (Waterloo) or Chinese characters (Hong Kong).
  • 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
  • Ocular pathology other than JMD or AMD that can significantly reduce central vision. Example: mild cataract of grade 2 or below is acceptable
  • Severe hearing impairment.
  • Contraindications for brain stimulation

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Andrew E Silva, PhD contact

a8silva@uwaterloo.ca

2 sites in 2 countries

Canada1 site, 1 recruiting
  • University of Waterloo

    Waterloo, Ontario, N2L 3G1

    Andrew E Silva, PhD, a8silva@uwaterloo.ca

    Recruiting

Other trials in Canada

Hong Kong1 site, 1 recruiting
  • The Hong Kong Polytechnic University

    Hung Hom, Kowloon

    Allen Cheong, PhD, allen.my.cheong@polyu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Improving Vision in Adults With Macular Degeneration, Study 2: The Effect of Concurrent Perceptual Learning and Brain Stimulation

The purpose of this study is to test whether a kind of brain stimulation called anodal transcranial direct current stimulation (a-tDCS) can be combined with perceptual learning to improve the ability of people with age-related macular degeneration (AMD) or juvenile macular degeneration (JMD) to read words presented to them on a computer screen better than if perceptual learning alone were used.

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.

Read the detailed description

This study will be carried out in Ontario, Canada (University of Waterloo) and Hong Kong (The Hong Kong Polytechnic University). There are two conditions: Active brain stimulation + perceptual training and sham/placebo brain stimulation + perceptual training. This study uses a between-subjects design, such that half of all participants will be placed in the active stimulation group and half will be placed in the sham group.

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.

Being tested
Active anodal tDCS, Sham anodal tDCS
Keywords
Macular Degeneration, Brain Stimulation, Psychophysics, Reading, tDCS, RSVP, Visual Acuity, Uncrowded Visual Acuity, Crowded Visual Acuity, Contrast Sensitivity
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active anodal tDCSDevice

    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 tDCSDevice

    The tDCS machine will be used as in active stimulation, except the electrical current will not be applied.

Study groups in NCT04762368
Study groupRoleWhat they receive
Active + TrainingActive comparatorParticipants 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.
Receives: Device: Active anodal tDCS
Sham + TrainingSham comparatorParticipants 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.
Receives: Device: Sham anodal tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Rapid Serial Visual Presentation (RSVP) Reading performance before and right after training.

    Behavioral Measure - Participants will verbally read words presented on a computer. A variety of speeds and sizes will be presented, so that an accurate measure of the maximum reading speed, and the smallest text size readable at the maximum reading speed can be calculated. The maximum reading speed and smallest text size will be measured before and after training. The outcome measures are the change in these reading measurements from pre test to post test.

    Measured: The pre test and post test will take roughly 1 hour to complete, and they will be roughly 4-7 weeks apart.

  2. Change in Rapid Serial Visual Presentation (RSVP) Reading performance 30 days after training

    Behavioral Measure - Participants will verbally read words presented on a computer. A variety of speeds and sizes will be presented, so that an accurate measure of the maximum reading speed, and the smallest text size readable at the maximum reading speed can be calculated. The maximum reading speed and smallest text size will be measured before and after training. The outcome measures are the change in these reading measurements from pre test to the 30 day follow up.

    Measured: The test will take roughly 1 hour to complete, and they will be roughly 7-10 weeks apart.

Secondary outcomes (8)
  1. Change in Uncrowded Visual Acuity before and just after training

    Visual acuity as measured by participants indicating the orientation of the gap present in a Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html . The outcome measure is the change in performance from pre test to the post test

    Measured: The pre test and post test will take roughly 5 minutes to complete, and they will be roughly 4-7 weeks apart.

  2. Change in Uncrowded Visual Acuity before and 30 days after training

    Visual acuity as measured by participants indicating the orientation of the gap present in a Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html . The outcome measure is the change in performance from pre test to the 30 day follow up.

    Measured: The pre test and post test will take roughly 5 minutes to complete, and they will be roughly 7 to 10 weeks apart.

  3. Change in Crowded Visual Acuity before and just after training

    Visual acuity as measured by participants indicating the orientation of the gap present in a Crowded (Ring) Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html . The outcome measure is the change in performance from pre test to post test.

    Measured: The tests will take roughly 5 minutes to complete, and they will be roughly 4 - 7 weeks apart.

  4. Change in Crowded Visual Acuity before and 30 days after training

    Visual acuity as measured by participants indicating the orientation of the gap present in a Crowded (Ring) Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html . The outcome measure is the change in performance from pre test to the 30 day follow up.

    Measured: The tests will take roughly 5 minutes to complete, and they will be roughly 7 - 10 weeks apart.

  5. Change in Contrast Sensitivity before and just after training

    Contrast sensitivity as measured by participants indicating the orientation of the gap present in a Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html . The outcome measure is the change in performance from pre test to the post test.

    Measured: The tests will take roughly 5 minutes to complete, and they will be roughly 4 - 7 weeks apart.

  6. Change in Contrast Sensitivity before and 30 days after training

    Contrast sensitivity as measured by participants indicating the orientation of the gap present in a Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html . The outcome measure is the change in performance from pre test to the 30 day follow up.

    Measured: The tests will take roughly 5 minutes to complete, and they will be roughly 7-10 weeks apart.

  7. Change in Temporal Visual Span before and just after training

    Three unrelated Chinese characters will appear at the centre of a monitor for a range of exposure times. Participants will be asked to recognize all three characters in a correct order. Both horizontal and vertical presentation will be assessed. The outcome measures are the changes in time for recognizing the characters from pre test to the post test.

    Measured: The test will take roughly 1.5 hours to complete, and they will be roughly 5-8 weeks apart

  8. Change in Spatial Visual Span before and just after training

    Three unrelated Chinese character will appear at different character positions for a fixed exposure time, while participants will be asked to keep fixation at the centre but recognize all three characters in a correct order. Both horizontal and vertical presentation will be assessed. The outcome measures are the changes in the size of the spatial visual span from pre test to the post.

    Measured: The test will take roughly 1.5 hours to complete, and they will be roughly 5-8 weeks apart.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start13 Feb 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A: 6 training sessions with active brain stimulation and perceptual training Group B: 6 training sessions with sham brain stimulation and perceptual training
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762368
Sponsor's protocol ID
VSBrainStim2
Status last verified
May 2025
First submitted
13 Feb 2021
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IDP that underlie results in a publication will be available after deidentification upon reasonable request to the research team.

Questions about this trial

What is this clinical trial studying?

A study testing Active anodal tDCS in people with Macular Degeneration, run by University of Waterloo at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ben Thompson, PhD (15198884567 ext. 39398, ben.thompson@uwaterloo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Rapid Serial Visual Presentation (RSVP) Reading performance before and right after training. (time frame: The pre test and post test will take roughly 1 hour to complete, and they will be roughly 4-7 weeks apart.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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