Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
Phase: NA
Conditions: Alzheimer Disease
Sponsor: Baycrest

 
 
Date: 9th August, 2022 
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Research Study Title:   Investigating if a stronger tDCS intensity is more effective for improving naming 
ability in people living with Alzheimer’s Disease 
Primary Investigator: Carlos Roncero, Rotman Research Institute, Baycrest Health Sciences, 
troncero@research.baycrest.org 
Co-Investigators: Howard Chertkow, Rotman Research Institute, Baycrest Health Sciences,  
hchertkow@research.baycrest.org 
Clinicaltrials.gov ID: NCT05509387 
INTRODUCTION: 
 
750,000 Canadians have dementia from Alzheimer Disease or other causes, this number will 
double within the next generation, and no new therapies have emerged in the past 20 years. However, a 
new promising therapy is transcranial direct current stimulation (tDCS), a near painless treatment where 
mild electrical current is applied through the scalp to the brain. This has been found to improve 
symptoms in people with dementia. Unfortunately, some studies have also reported that tDCS failed to 
improve symptoms in their participants, so it’s important to understand why tDCS seems to work in 
some cases, but fails to produce an improvement in other cases.  One possible reason is the intensity 
level of tDCS, which is normally 2 mA in studies. Some researchers believe a higher intensity level, 4 mA, 
would produce a bigger improvement.   
LITERATURE REVIEW: 
 
Symptomatic therapy in neurodegenerative diseases (NDD) is very limited. Since 
introduction of the cholinesterase inhibitors in 1995 and Memantine in 2002, there have been no 
new available pharmaceutical therapies. As a result, researchers are looking beyond chemicals for a 
means to ameliorate cognitive impairment. Neuromodulation, particularly tDCS has garnered 
increasing attention as a potential ancillary symptomatic brain therapy for neurological and 
psychiatric conditions, reaching the level of being made clinically available for pain and depression 
[1, 2].  

 
 
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In tDCS, two electrodes (anode and cathode) are secured to the scalp and continuous 
current flows through the brain from anode to cathode, which modulates corresponding neural 
activity. It has been theorized that if these neuronal pathways are activated to a certain level, a 
long-lasting change will occur in the network which allows information to be more easily retrieved 
or remembered. Consistent with this hypothesis, recent studies at a few centers have shown 
clinically meaningful improvement in individuals with neurodegenerative diseases treated with 
transcranial direct current stimulation (tDCS). For instance, we have previously shown a robust 
effect of improved picture naming [3-4] in individuals with Primary Progressive Aphasia (PPA) and 
people living with dementia who also suffered from anomia [5]. We have also published case 
reports where tDCS improved the quality of life in an individual with advanced dementia [6] and 
walking speed in a person with Progressive Supranuclear Palsy [7]. Others have found similar results 
[8-10]. We have shown that anomia (picture naming deficits) is improved with seven to ten daily 
half-hour sessions of tDCS along with language training, for both AD and FTD [3-7, 28, 32-34], with 
effects lasting several weeks. 
 
Despite these encouraging results, studies examining tDCS for people with dementia have 
produced variable results. For example, Khedr et al. [11] reported positive tDCS effects, whereas 
Cottelli et al.[12] and Suemoto et al.[13] reported no improvement or equivalence to a placebo 
condition. Neuromodulation, however, is both diverse and relatively recent, with differences 
between approaches, techniques, and electrode montages across studies, making it difficult to 
compare results. As reported by Prehn and Flöel [14] in their review of tDCS for people with 
dementia: “The most effective stimulation parameters for enhancing cognitive function in older 
subjects and patients with AD and MCI are still unclear.” 

 
 
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Our research has increasingly focused on identifying the parameters that increase efficacy. 
For example, in our previous study [5], we found a montage focused on the parietal lobe was 
superior to one focused on the dorsolateral prefrontal cortex (DLPFC) for improving naming ability. 
Finding such parameter optimizations is critical for advancing tDCS as a therapy for people with 
dementia as we learn to tailor its administration. In the current project, our central goal is to 
examine a critical additional stimulation parameter: intensity. 
RATIONALE: 
 
tDCS studies typically report significant group effects despite the variability demonstrated 
among participants, with some showing clear, meaningful improvement, while others only show 
statistical improvement or none at all. These variable results may be related to the conventional 
stimulation intensity level of 2mA. Recent evidence suggests an electric field of at least one v/m is 
needed to affect local networks in the brain [15] reliably. However, tDCS at 2mA produces an 
electric field around only 0.6 v/m because a large amount of shunting (a dilution of the incoming 
current) occurs as the current travels from the electrode on the scalp, through the skin, skull, and 
cerebral spinal fluid (CSF), before reaching the brain. The most direct way to increase the electric 
field produced in the brain is to increase the intensity delivered. Current tDCS machines can have an 
intensity level of 4mA, resulting in more substantial electric fields than one v/m. We predict that if 
we were to administer tDCS at 4.0 mA, a more significant number of participants would show a 
meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to 
having a larger electric field produced. 
 
We aim to test this hypothesis in people with Alzheimer’s Disease because they have unique 
attributes that may impact tDCS differently from other populations. More specifically, the amount 

 
 
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of shunting is predicted to be larger due to increasing CSF from brain atrophy [16]. Thus, 2mA may 
be too weak to be very effective in some people with Alzheimer’s Disease due to the higher level of 
shunting. More significant improvements would be observed from a higher intensity level that can 
better interact with the remaining cortex. Alzheimer’s Disease is also predominately female, and 
past studies have suggested men and women respond differently to tDCS [17-24]. For example, 
women have smaller skulls than men in general, which are predicted to receive more of the 
incoming stimulation. Finally, as Alzheimer’s Disease is progressive, the degree of impairment may 
be relevant [25]. We will check if individuals who are more impaired benefit more when the 
stimulation intensity is set higher. The level of impairment will be measured in two ways: (1) the 
baseline score on a naming task (baseline severity); and (2) scores collected from cognitive testing 
(cognitive severity). 
Purpose of the Research 
 
tDCS has the potential to emerge an effective ancillary symptomatic therapy for Alzheimer’s 
Disease.  However, the optimal tDCS parameters are unknown, improvement varies from person to 
person, and we cannot presently predict who will most benefit from tDCS. The proposed project 
aims to fill this knowledge gap by investigating how different variables impact the effectiveness of 
tDCS. In this manner, the proposed project will provide a significant step forward towards finding 
the optimal participants for treatment as well as the optimal tDCS delivery method for people with 
AD. This work, using a proven naming task, is an essential step towards future random clinical trials 
investigating tDCS as therapy for people with AD. 
 
 

 
 
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Hypotheses Addressed  
The degree of improvement observed in people with Alzheimer’s disease will be significantly 
 
greater when training is carried out at higher stimulation intensity (4mA vs. 2mA, SHAM).  
There will be significantly more significant improvement observed when:  
 
1. Individuals have more atrophy (decreased brain volume, higher CSF volume).  
 
2. Individuals have a higher degree of impairment 
 
3. The participant is female (possibly due to skull differences).  
PRELIMINARY STUDIES  
 
The proposed study models after our original three-round study [5] where three different 
tDCS montages were compared for improving naming ability. We recently completed another 
three-round study [28] where a mixed group of people with dementia (AD and FTD) concluded 
three consecutive rounds of executive function training with either: 4mA tDCS targeted towards the 
left dorsolateral prefrontal cortex (DLPFC), 2mA tDCS via two anode electrodes to the left and right 
DLPC respectively, or SHAM stimulation, which is the accepted placebo condition in tDCS studies. In 
SHAM stimulation, tDCS is only briefly active at the beginning and end of the session, which mimics 
the real-life sensation of tDCS as feelings are felt mainly only at the beginning and end of the 
session when the current is ramping up or down. We measured how much participants improved 
on an N-Back task, defined as having faster response times. For evaluation, participants completed 
two versions of this N-Back task: one practiced during the tDCS sessions, and another never 
practiced and was only given during evaluations. For trained items, results were similar regardless 
of stimulation condition, but for untrained items, the largest improvement was found for 4mA tDCS 
(see Figure 1 below). 4 mA tDCS was also well tolerated with no adverse effects among the 24 
individuals who participated. Building on this work, we now propose to carry out a training 

 
 
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paradigm to compare 4 mA, 2 mA, or SHAM, but using picture naming, a domain we have already 
shown to improve with tDCS in our previous studies [4-6], with tDCS again targeting the Inferior 
Parietal Lobe (IPL). 
Figure 1: 
 
METHODS: 
Sample 
Based on the previous study where tDCS was used for language training [6], we expect a 
partial eta square around 0.20. For 80% power to detect a difference across the three levels of 
intensity, while also accounting for the sex of a participant, a repeated-measures ANOVA test at an 
alpha level of 5% will require 54 participants with AD (27 men and 27 women). To compensate for 
anticipated attrition over the study, we will recruit a sample of 30 men and 30 women, 60 total.   
These participants would have received the diagnosis of probable AD from Baycrest’s 
Memory Clinic expert staff [29, 30] according to standard clinical criteria. Only patients with no 
family history of epilepsy and who can give consent will be tested. We will seek people with mild to 

 
 
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moderate AD (Reisberg stages 3, 4, or 5, [34]) who score between 18 and 25 on the MoCA [26]. 
Participants must show no history of stroke or traumatic brain injury, nor shunts or metal in the 
head that could interfere with the delivery of tDCS. Finally, people will have no evidence of 
significant heart disease, alcoholism, drug use. All enrolled participants will be expected to 
complete an MRI; however, if they are unable to complete an MRI due to the presence of an 
exclusion criterion, they will still be allowed to complete all subsequent stages of the study. 
Participants will be evaluated and trained using different naming lists each round. We have 
developed equivalent versions of these naming lists in our lab, which allows us to use a different 
trained and untrained list each round.  
Recruitment and Pre-Assessment 
 
All participants are recruited following the same enrollment protocol: Initial contact, 
screening, and pre-assessment. For the initial contact, the research coordinator will receive names 
of potential participants from the Clinical Trials Unit at Baycrest. The files of these individuals will be 
acquired from Sam & Ida Ross’s Memory Clinic. Their contact information and diagnosis will be 
noted. They will then be contacted using a prepared telephone script. Those individuals who show 
interest in the study will then be scheduled a screening with Dr. Carlos Tyler Roncero.  
This screening can be done in person at Baycrest, or virtually over Zoom, and the 
participants can choose a particular modality if they have a preference. During the screening, Dr. 
Roncero will go over the consent form with the participant, including the mechanics, history, and 
side-effects of tDCS, and the planned study design (i.e., what participation would entail schedule-
wise). The screening also allows Dr. Roncero to evaluate subjectively if the person may be too 
impaired for the study (for example, if they are unable to communicate or answer questions during 
the screening). If this scenario were to arise, Dr. Roncero would explain to the participant, and 

 
 
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presumed caregiver, that the person is too impaired for the study. The screening is also an 
opportunity for the potential participant to ask any questions they might have. Assuming the 
participant is agreeable to participating in the study, a pre-assessment will be scheduled.  
In this pre-assessment, the participant will be asked to complete versions of the tasks that will be 
administered during the study. In this manner, we can further verify that the potential participant is 
a good candidate for completing the study. Assuming they are able to successfully complete the 
tasks during the pre-assessment, and continued to be interested in participation, he or she would 
then be formally enrolled and scheduled into the study. Otherwise, the participant would be 
explained that they are unable to be enrolled into the study because they are unable to successfully 
complete the tasks planned. Because tDCS is an interactive therapy (a targeted behaviour must 
occur while the stimulation is administered), it is crucial that participants be able to complete the 
planned tasks, and simply receiving tDCS passively (i.e., while doing nothing) would be largely, if not 
completely, ineffective. 
tDCS Parameters 
 
As done in our previous three-round study where naming training was paired with tDCS [5], 
stimulation will last for 20 minutes, concurrent with the beginning of the session. The anode 
electrode placed will again be placed over the IPL and the cathode over the right supraorbital 
region. Figure 2 shows the expected stimulation pattern.   

 
 
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Study Design 
 
 Participants will be randomized into three treatment arms. Participants will complete three 
rounds of executive function training in each arm, with each round paired with different stimulation 
intensity (SHAM, 2mA, 4mA). The below flowchart displays the procedure that participants will 
follow: 

 
 
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Initial Assessment 
 
 In the first week, all participants will receive an initial assessment to gather demographic 
information (age, sex, years of education, racial background, and hand preference) and conduct a 
formal evaluation of participants. Evaluation includes the Montreal Cognitive Assessment (MoCA; 
[26]) and the Mini-Mental State Exam (MMSE; [27]) to assess the level of cognitive function. The 
Naming Task of the Cambridge Semantic Battery will be given to verify the presence of anomia (an 
inclusion criterion of the study). From these tasks, participants’ impairment scores will be 
calculated. Cognitive severity will be measured as the combined total from the MoCA and MMSE 
(x/30 + x/30). In contrast, baseline severity will be measured as the score obtained on this naming 
task. Assuming inclusion criteria are met, participants in the first week will also complete a 
structural MRI [view MRI protocol – page 11]. We will use SPM 12 to calculate a person’s skull 
thickness and grey matter volumes around the IPL, as well as the CSF level, which will be quantified 
relative to the overall skull size of the participant.  

 
 
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Baseline Evaluation  
 
Neither the evaluators nor the participants will be told if the tDCS they received during the 
training sessions was 2mA, 4mA, or SHAM. Therefore, the study will be double-blind. The first 
session of each round will consist of a baseline evaluation prior to the training session where 
participants will be asked to name presented images from two lists: one that will be subsequently 
trained that round, and a second list that will be left untrained. By administering two lists during 
evaluation, one trained, one untrained, we can examine the impact of tDCS on training, and if this 
improvement generalizes to an untrained naming list.  General Cognitive Status, as measured by the 
MoCA and MMSE. Mood, assessed by the Geriatric Depression Scale (GDS, [35]). 
Training Sessions 
 
 The language training protocol will be the same we have previously published [5], which 
successfully improved naming in people with dementia. All training sessions will have the same 
format and involve the administration of tDCS combined with training. More specifically, during the 
first 20 minutes, a research participant will give sham or tDCS set at 2mA or 4mA for 20 minutes. 
After a research assistant has set up the tDCS machine and started stimulation, the participant is 
presented 45 images (from Snodgrass and Vanderwart; [31]) individually on a laptop, one by one, 
and asked to name each item that appears. Items have a range of difficulty and familiarity, which 
ensures it can be used for participants with different levels of impairment; perfect scores and scores 
of zero are unexpected. The research assistant notes which items were incorrectly named. These 
misnamed images will then be ranked in familiarity from the most familiar to the least familiar, 
based on norms collected in our lab. The five most familiar missed items will form a five-item study 
group. The trainer then presents each item of the study group one by one to the participant, 
naming each item in front of the participant. Next, the five images are presented one by one again, 

 
 
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but now the participant is asked to name them. When participants have difficulty remembering the 
name of the item, the trainer will give phonological cues (starts with a . . .) or semantic cues (In 
Halloween, you carve a . . .). This group of items is then shown again one by one a second and a 
third time, each time noting if the participant can correctly name it.  
After the study group is presented three times, those items correctly named by the 
participant three times in a row without cues are replaced with the next most familiar item that was 
missed at the beginning of the session. Thus, when the study group is presented a fourth time, it 
contains images that the participant still hasn’t named three times in a row or new items that 
replaced ones named three times in a row. The training session will continue in this manner, 
replacing items named three times in a row, maintaining those yet to be named successfully three 
times, until all items missed at the beginning of the session are incorporated into the study group 
and trained with the participant.  
In summary, training sessions have participants practice picture naming, as might occur in a 
typical speech therapy session for anomia, except the first 20 minutes are concurrent with tDCS, 
which is typical in tDCS studies. Most sessions will last around an hour. Due to the training involved, 
we expect participants will improve regardless of the stimulation condition but predict this 
improvement will be larger when done with real tDCS, and largest when done with 4mA tDCS. 
Related to this, we will check if this superiority of 4 mA over 2 mA is related to a participant’s 
condition (e.g., sex, level of atrophy). 
Subsequent Evaluations 
 
 For each round, in addition to the evaluation just before the first stimulation session, an 
additional evaluation will take place during the final training session, and two weeks later after the 

 
 
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final session. In this manner, we can obtain a baseline measurement, check for post-stimulation 
changes, and if those changes have continued two-week’s post-stimulation.  
Structural MRI Protocol 
 
Participants will undergo a Structural MRI at Baycrest. The protocol has been informed to 
the MR Technicians (please see attached documents). The Project Coordinator will book the MR 
suite using the Baycrest MR Web Scheduler with a 72 hour notice at the least. 
 
Participants will be asked to arrive 15 minutes before their scheduled scan to review and fill 
the consent and MR screening forms. The participant will then be escorted to the Interview room to 
be interviewed by a Level 11 MR Personnel with respect to their MR screening form and medical 
history prior to changing for the MR exam. After changing, the MR technologist will escort the 
research participant into the magnet room and the accompanying researcher (Assistant, 
Coordinator or PI) to the control area. Post scanning, the lab member accompanying the research 
participant will monitor the change process, and other processes outlined in the “MR Research 
Suite Process Bacycrest – RRI.”  
 
To be able to successfully perform the MRI, lab members will undergo the Virtual MR Safety 
Training & Orientation session and will also receive an in person suite tour.  
 
 
 
 
Planned Analyses 
 
The primary outcome measure will be improvement on the naming lists administered, both 
a trained version and an untrained version. Improvement will be measured in terms of the number 

 
 
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of images correctly named post-training compared to baseline. A repeated-measures ANOVA will be 
run to compare the three stimulation conditions (SHAM, 2mA, 4mA) with sex (male, female) as a 
between-subject variable. This analysis will be conducted separately for the trained and untrained 
items. We expect to find the greatest improvement in the 4mA condition.  
Next, we will calculate how much a participant improved in each condition by taking the 
naming score obtained at baseline for a naming list and subtracting it from the naming score 
obtained in the final stimulation session (e.g., 32 (final) – _20 (baseline) = an improvement score of 
12). These scores are then used to produce tDCS effectiveness scores: the improvement score in the 
4mA condition minus the improvement score in the SHAM condition; and the improvement score in 
the 2mA condition minus the improvement score in the SHAM condition. These tDCS effectiveness 
scores will then be the dependent variables in a multivariate logistic regression; once for trained 
items, one for untrained items. The predictors will be the CSF level of a participant, grey matter 
volumes and skull thickness around the IPL, impairment scores (baseline and cognitive severity), 
and interactive terms representing the sex of the participant. In this manner, we can examine what 
individual differences predict the tDCS response in people with AD, and if these predictors are the 
same for 2mA and 4mA tDCS, while checking for sex differences. We expect more significant levels 
of CSF, less IPL grey matter, thicker skulls, and greater impairment levels will be predictive of more 
substantial improvement in the 4mA condition because this stimulation intensity is needed to 
compensate for higher levels of shunting and severity. CSF and grey matter values may be less 
predictive for how well women respond to tDCS as their relatively smaller heads could compensate 
for increased shunting levels. 
Funding 

 
 
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This study is supported by the Alzheimer’s Scoiety, which reviewed the submitted protocol, and  
awarded funds to Dr. Carlos Tyler Roncero towards completing the proposed study.  
Risks 
 
The tDCS protocol for this experiment was determined according to the best practices observed 
in previous research using tDCS stimulation [45]. Furthermore, tDCS is safe, has virtually no side effects, 
is technically easy to carry out, and is not uncomfortable to undergo [46,47]. Multiple studies have also 
reported that the administration of 4 ma tDCS has no more adverse effects than 2 ma tDCS [48]. No 
incidence of seizure has been recorded, although side effects could include headache, drowsiness, 
itching sensation, nausea, and, in rare cases, disorientation.  In our experiences, the only observed and 
reported side-effect has been temporary redness post-stimulation where the sponge was placed, as well 
as the occasionally reported headache.   
 
If the event were to result in lasting pain and hospitalization, then it would be reported as a 
‘Serious Adverse Event” and full details would be noted to the research ethics board as well as Health 
Canada. These events would be recorded on the worksheets being used to collect the rest of the data. 
We must stress, however, that after administering 4 mA tDCS to around 60 participants, for hundreds of 
tDCS sessions, we have never encountered any such event. Although we have safety protocols in place 
for any encountered adverse or severe adverse events, we believe such events will fail to occur in the 
present study. 
 
 
 
Confidentiality 
 
A research study file as well as medical records identifying participants will be maintained within 
Dr. Howard Chertkow’s lab. Names and identifying information will be replaced with a code, and the 

 
 
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information will be kept on file for 10 years after the end of the study. Data collected from participants’ 
who withdraw from the study will also be kept, unless participants withdraw consent for its use.  
Communication and Publication of Research Results 
 
The found results may be presented at research conferences and written up in a manuscript 
submitted for a publication in a respected science journal. The data will never be used for commercial 
goals and all participant information will remain confidential. Individual’s participant data will be 
presented using a code (e.g., Participant 1), which ensures no reader of the data could identify the 
participant. The results found can also be used to back-up further studies involving 4 mA tDCS because 
we will be able to present formal data demonstrating its effectiveness compared to other intensities of 
stimulation (SHAM, 2mA) in people with Alzheimer‘s Disease.  
 
 
 
 
 
 
 
 
 
 
 
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