Macular DegenerationNCT04111068
Improving Vision in Adults With Macular Degeneration
A study testing anodal tDCS Active Stimulation in people with Macular Degeneration, run by University of Waterloo at 2 sites in 2 countries.
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 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. 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?
- anodal tDCS Active Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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+).
- Central vision loss and use of a peripheral preferred retinal locus (PRL) to fixate on visual objects, as confirmed by a microperimeter.
- Visual acuity (VA); between 0.5 and 1.0 logMAR inclusive (6/18-6/60) in the better eye.
- Best-corrected near visual acuity of 4.0M at 40 cm or better in the better eye
- Stable vision for the previous 3 months (by patient report).
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.
- Ocular pathology other than JMD or AMD that can reduce central vision.
- Severe hearing impairment.
- Contraindications for brain stimulation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Improving Vision in Adults With Macular Degeneration, Study 1: the Effect of 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 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. 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. The investigators will test the ability of participants to read words before and after the application of stimulation. The difference between the pre and post tests when receiving active stimulation will be compared to the difference when receiving sham stimulation, because sham stimulation is not expected to improve reading beyond a placebo. The aim of the study is to examine the potential of brain stimulation 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 and secondary measures 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 and sham/placebo brain stimulation. This study uses a within-subjects design, such that all participants will take part in both conditions on separate sessions.
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 first or the placebo stimulation first.
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 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 study consists of 3 sessions:
Session 1: The first session will include the clinical evaluation. In addition, the first session will also collect the participant's individual RSVP performance threshold by presenting a variety of reading speeds and print sizes. The selected threshold will be the combination of print size and presentation speed required for a given participant to achieve roughly 55% performance accuracy.
Session 2 and 3: Brain stimulation sessions. At the start of each session, participants will perform baseline pre tests for the uncrowded and crowded visual acuity tasks as well as the RSVP task using their selected threshold from Session 1. They will then undergo a-tDCS to their primary visual cortex - this stimulation may be either active or placebo on any given day, but all participants will have been exposed to both sham and placebo by the end of Session 3. During the brain stimulation, participants will perform post tests for the primary outcome measure (RSVP) and the two secondary outcome measures (crowded and uncrowded visual acuity). Five minutes after the completion of the brain stimulation, participants will again perform all three post tests. A third set of post tests will be completed 30 minutes after the completion of the brain stimulation.
All outcome measures will be analyzed by comparing the baseline (pre test) scores to the post test scores, examining whether the active brain stimulation condition resulted in greater post test improvement relative to the placebo brain stimulation condition. The time course of the effect of brain stimulation will also be examined by comparing the effect of brain stimulation at each of the 3 post tests to one another.
- Conditions
- Macular Degeneration
- Being tested
- anodal tDCS Active Stimulation, anodal tDCS Sham/Placebo Stimulation
- Keywords
- Macular Degeneration, Brain Stimulation, Psychophysics, Reading, tDCS, RSVP, Visual Acuity, Uncrowded Visual Acuity, Crowded Visual Acuity
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal tDCS Active StimulationDevice
a weak electric current is applied to the head through electrodes to affect the cortical excitability of the targeted cells in the brain.
anodal tDCS Sham/Placebo StimulationDevice
The tDCS machine will be used as in active stimulation, except the electrical current will not be applied.
| Study group | Role | What they receive |
|---|---|---|
| Active then Sham | Experimental | Participants in this arm will be exposed to active stimulation during session 1 and sham/placebo stimulation during session 2 Receives: Device: anodal tDCS Active Stimulation; Device: anodal tDCS Sham/Placebo Stimulation |
| Sham then Active | Experimental | Participants in this arm will be exposed to sham/placebo stimulation during session 1 and active stimulation during session 2 Receives: Device: anodal tDCS Active Stimulation; Device: anodal tDCS Sham/Placebo Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Serial Visual Presentation (RSVP) Reading Pre-Test
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected.
Measured: This test is roughly 6 minutes in length, occurring before brain stimulation.
Rapid Serial Visual Presentation (RSVP) Reading Post-Test 1 (during stimulation)
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected without accounting for any effects of stimulation.
Measured: This test is roughly 6 minutes in length, occurring during the 20 minute brain stimulation period.
Rapid Serial Visual Presentation (RSVP) Reading Post-Test 2 (5 min after stimulation)
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected without accounting for any effects of stimulation.
Measured: This test is roughly 6 minutes in length, occurring 5 minutes after the completion of stimulation.
Rapid Serial Visual Presentation (RSVP) Reading Post-Test 3 (30 min after stimulation)
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected without accounting for any effects of stimulation.
Measured: This test is roughly 6 minutes in length, occurring 30 minutes after the completion of stimulation.
Secondary outcomes (8)
Uncrowded Visual Acuity Pre-Test
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
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Pre-Test" before brain stimulation.
Uncrowded Visual Acuity Post-Test 1 (during stimulation)
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
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 1" while brain stimulation is ongoing.
Uncrowded Visual Acuity Post-Test 2 (5 min after Stimulation)
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
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 2" 5 minutes after brain stimulation completion.
Uncrowded Visual Acuity Post-Test 3 (30 min after Stimulation)
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
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 3" 30 minutes after brain stimulation completion.
Crowded Visual Acuity Pre-Test
Visual acuity as measured by participants indicating the orientation of the gap present in a Crowded Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html. The Crowded Landolt C stimulus adds a solid black ring round the standard Landolt C stimulus and generally results in poorer performance.
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Pre-Test" before brain stimulation.
Crowded Visual Acuity Post-Test 1 (during stimulation)
Visual acuity as measured by participants indicating the orientation of the gap present in a Crowded Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html. The Crowded Landolt C stimulus adds a solid black ring round the standard Landolt C stimulus and generally results in poorer performance.
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 1" while brain stimulation is ongoing.
Crowded Visual Acuity Post-Test 2 (5 min after stimulation)
Visual acuity as measured by participants indicating the orientation of the gap present in a Crowded Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html. The Crowded Landolt C stimulus adds a solid black ring round the standard Landolt C stimulus and generally results in poorer performance.
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 2" 5 minutes after brain stimulation completion.
Crowded Visual Acuity Post-Test 3 (30 min after stimulation)
Visual acuity as measured by participants indicating the orientation of the gap present in a Crowded Landolt C stimulus using the freely available FrACT software https://michaelbach.de/fract/index.html. The Crowded Landolt C stimulus adds a solid black ring round the standard Landolt C stimulus and generally results in poorer performance.
Measured: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 3" 30 minutes after brain stimulation completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Dec 2019
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- 1 session of active brain stimulation and 1 session of placebo sham stimulation. Each participant will perform both sessions in a randomly-assigned order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Ben Thompson, University of Waterloo
- Investigators
- Ben Thompson, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111068
- Sponsor's protocol ID
- VSBrainStim1
- Status last verified
- Apr 2022
- First submitted
- 23 Sep 2019
- Last updated
- 29 Apr 2022
- 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 upon reasonable request to the research team.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vision in Adults With Macular Degeneration, Study 1: the Effect of Brain Stimulation
- ClinicalTrials.gov ID
- NCT04111068
- Acronym / sponsor ID
- VSBrainStim1
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration, Brain Stimulation, Psychophysics, Reading, tDCS, RSVP, Visual Acuity, Uncrowded Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether a kind of brain stimulation called anodal transcranial direct current stimulation (a-tDCS) can 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. 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. The investigators will test the ability of participants to read words before and after the application of stimulation. The difference between the pre and post tests when receiving active stimulation will be compared to the difference when receiving sham stimulation, because sham stimulation is not expected to improve reading beyond a placebo. The aim of the study is to examine the potential of brain stimulation 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 and secondary measures due to an increase in the cortical excitability of the stimulated brain cells.
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 and sham/placebo brain stimulation. This study uses a within-subjects design, such that all participants will take part in both conditions on separate sessions.
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 first or the placebo stimulation first.
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 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 study consists of 3 sessions:
Session 1: The first session will include the clinical evaluation. In addition, the first session will also collect the participant's individual RSVP performance threshold by presenting a variety of reading speeds and print sizes. The selected threshold will be the combination of print size and presentation speed required for a given participant to achieve roughly 55% performance accuracy.
Session 2 and 3: Brain stimulation sessions. At the start of each session, participants will perform baseline pre tests for the uncrowded and crowded visual acuity tasks as well as the RSVP task using their selected threshold from Session 1. They will then undergo a-tDCS to their primary visual cortex - this stimulation may be either active or placebo on any given day, but all participants will have been exposed to both sham and placebo by the end of Session 3. During the brain stimulation, participants will perform post tests for the primary outcome measure (RSVP) and the two secondary outcome measures (crowded and uncrowded visual acuity). Five minutes after the completion of the brain stimulation, participants will again perform all three post tests. A third set of post tests will be completed 30 minutes after the completion of the brain stimulation.
All outcome measures will be analyzed by comparing the baseline (pre test) scores to the post test scores, examining whether the active brain stimulation condition resulted in greater post test improvement relative to the placebo brain stimulation condition. The time course of the effect of brain stimulation will also be examined by comparing the effect of brain stimulation at each of the 3 post tests to one another.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1 session of active brain stimulation and 1 session of placebo sham stimulation. Each participant will perform both sessions in a randomly-assigned order.
| Arm | Type | Receives |
|---|---|---|
| Active then Sham | Experimental | Device: anodal tDCS Active Stimulation, Device: anodal tDCS Sham/Placebo StimulationParticipants in this arm will be exposed to active stimulation during session 1 and sham/placebo stimulation during session 2 |
| Sham then Active | Experimental | Device: anodal tDCS Active Stimulation, Device: anodal tDCS Sham/Placebo StimulationParticipants in this arm will be exposed to sham/placebo stimulation during session 1 and active stimulation during session 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of AMD (age 60+) or JMD (current age 18+).
- Central vision loss and use of a peripheral preferred retinal locus (PRL) to fixate on visual objects, as confirmed by a microperimeter.
- Visual acuity (VA); between 0.5 and 1.0 logMAR inclusive (6/18-6/60) in the better eye.
- Best-corrected near visual acuity of 4.0M at 40 cm or better in the better eye
- Stable vision for the previous 3 months (by patient report).
Key exclusion criteria (6 listed)
- 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.
- Ocular pathology other than JMD or AMD that can reduce central vision.
- Severe hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anodal tDCS Active Stimulationa weak electric current is applied to the head through electrodes to affect the cortical excitability of the targeted cells in the brain. | Device | Active then Sham, Sham then Active |
| anodal tDCS Sham/Placebo StimulationThe tDCS machine will be used as in active stimulation, except the electrical current will not be applied. | Device | Active then Sham, Sham then Active |
Primary outcome
Rapid Serial Visual Presentation (RSVP) Reading Pre-Test
Time frame: This test is roughly 6 minutes in length, occurring before brain stimulation.
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected.
Rapid Serial Visual Presentation (RSVP) Reading Post-Test 1 (during stimulation)
Time frame: This test is roughly 6 minutes in length, occurring during the 20 minute brain stimulation period.
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected without accounting for any effects of stimulation.
Rapid Serial Visual Presentation (RSVP) Reading Post-Test 2 (5 min after stimulation)
Time frame: This test is roughly 6 minutes in length, occurring 5 minutes after the completion of stimulation.
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected without accounting for any effects of stimulation.
Rapid Serial Visual Presentation (RSVP) Reading Post-Test 3 (30 min after stimulation)
Time frame: This test is roughly 6 minutes in length, occurring 30 minutes after the completion of stimulation.
Behavioral Measure - Participants will verbally read words presented on a computer. The speed of the presentation and the size of the words will be personalized to the participant so that roughly 50% accuracy can be expected without accounting for any effects of stimulation.
8 secondary outcomes
Uncrowded Visual Acuity Pre-Test
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Pre-Test" before brain stimulation.
Uncrowded Visual Acuity Post-Test 1 (during stimulation)
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 1" while brain stimulation is ongoing.
Uncrowded Visual Acuity Post-Test 2 (5 min after Stimulation)
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 2" 5 minutes after brain stimulation completion.
Uncrowded Visual Acuity Post-Test 3 (30 min after Stimulation)
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 3" 30 minutes after brain stimulation completion.
Crowded Visual Acuity Pre-Test
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Pre-Test" before brain stimulation.
Crowded Visual Acuity Post-Test 1 (during stimulation)
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 1" while brain stimulation is ongoing.
Crowded Visual Acuity Post-Test 2 (5 min after stimulation)
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 2" 5 minutes after brain stimulation completion.
Crowded Visual Acuity Post-Test 3 (30 min after stimulation)
Time frame: Roughly 2 minutes in length, administered after the primary outcome measure "RSVP Reading Post-Test 3" 30 minutes after brain stimulation completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Yes. IDP that underlie results in a publication will be available upon reasonable request to the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Thompson, PhD principal investigator
University of Waterloo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal tDCS Active Stimulation 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: finished, as of the sponsor's last update on 29 Apr 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Serial Visual Presentation (RSVP) Reading Pre-Test (time frame: This test is roughly 6 minutes in length, occurring before brain stimulation.). The study lists 4 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 29 Apr 2022.