Evaluating Anodal tDCS Preceding Aphasia Therapy
Phase: PHASE1
Conditions: Stroke, Aphasia
Sponsor: Northwell Health

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Protocol Title: 
Evaluating Anodal tDCS Preceding Aphasia Therapy 
 
Principal Investigator: 
Bruce T. Volpe, M.D.  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Introduction 
 

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Aphasia is a communication deficit resulting from a brain injury or a stroke.  It can affect one’s 
ability to speak, understand, read, and write, though the hallmark symptom is a word-finding 
deficit. It is estimated that there are 80,000 new cases of aphasia per year in the United States, 
and approximately 1 million people in the United States today, suffer from aphasia (1).  
Traditional aphasia therapy focuses on both training of compensatory strategies for 
communication and mass practice of communication skills with hierarchical cueing from an SLP 
(Speech and Language Pathologist). For example, an individual with aphasia may learn to point 
to pictures on a communication board to express wants/needs or practice simple object naming 
with progressively fewer and less supportive verbal or gestural cues.  These therapy techniques 
have remained relatively unchanged since the early 1990’s.  Recent stroke rehabilitation research 
has suggested that non-invasive brain stimulation techniques, such as transcranial direct current 
stimulation (tDCS), may augment the benefits of traditional rehabilitation by modulating cortical 
activation, and priming the cortex for improved motor and cognitive recovery.  tDCS combined 
with aphasia therapy has been shown to improve naming, verbal fluency, repetition, and 
linguistic cohesion for conversational narratives (2-10).   
 
However, debate remains over the optimal parameters for cortical stimulation including 
intensity, location, polarity (anodal/cathodal), and timing.  Most research on tDCS and language 
therapy has applied neurostimulation during language treatment (2, 4, 5, 8, & 10). However, 
others, using tDCS in patients recovering motor function after a stroke, have found the greatest 
improvement when anodal tDCS preceded robotic hemiplegia training (11). In a pilot study, we 
want to  test the hypothesis that  anodal tDCS delivered  before language treatment will affect the 
naming ability in patients with aphasia after chronic stroke (greater than 6 months from acute 
injury).   
 
Specific Aims 
 
 
SPECIFIC AIM 1: To evaluate whether anodal tDCS preceding aphasia therapy 
significantly improves picture naming in individuals with post-stroke aphasia. 
 
In patients with chronic post-stroke aphasia, we will use a within-subjects repeated-measures 
design, to evaluate the effects of computerized mass practice audiovisual word-picture matching  
therapy (5 day/week x1 week) preceded by 20 min of anodal tDCS.  Functional improvement 
will be determined by changes in naming accuracy on trained and untrained word lists.  
 
We are aware that naming is one aspect of the language impairment that may occur after stroke. 
Thus, we will also measure other aspects of language function, so that if naming does not change 
there will be additional tests of the hypothesis.  
 
SPECIFIC AIM 2: To compare naming performance between intervention groups (tDCS 
and sham stimulation).     
 
We will use a  single-subject cross-over design to compare two tDCS conditions (1mA anodal 
vs. sham).  Treatment sessions will occur for five consecutive days per condition, with one week 
between conditions (3 weeks total).  Functional improvement will be determined by changes in 
naming accuracy on trained and untrained word lists.  

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If neuromodulation (tDCS) preceding treatment is effective for promoting robust recovery in 
naming ability , as it has demonstrated  for motor recovery in patients with chronic stroke and 
hemiplegia, then we expect the improvement in naming accuracy to be greater following anodal 
tDCS compared with sham tDCS.   
 
These pilot results will support or not the continued investigation of novel non-invasive 
neuromodulation techniques.  
 
SPECIFIC AIM 3: To compare naming performance between severity groups (high vs. low 
functioning aphasia as determined by admission Western Aphasia Battery scores (WAB)). 
 
 
Preliminary Data 
 
There is an increasing understanding of the mechanism of action of tDCS. Further and most 
importantly, there is clinical demonstration of its safety and efficacy (20-25).  tDCS  modulates  
the  excitability  of  a  targeted  brain  region  non-invasively  by  altering  neuronal  membrane 
potentials (12, 13). Hence this technique will  increase or decrease the excitability of neurons in a 
brain area, depending on electrode placement, and can thus be used to determine whether activity 
in a particular brain  region can affect a  specific  motor/cognitive  function.  tDCS does not 
cause neurons to fire, but alters the likelihood that neurons will fire by hyperpolarizing or 
depolarizing brain tissue. The prolonged effects of tDCS have been attributed to long-term 
potentiation (LTP) and long-term depression (LTD) (14-19). In animals, anodal cortical 
stimulation of 5-30 minutes has been shown to cause excitability increases lasting for hours after 
the stimulation, primarily through modulation of the resting  membrane potential  (26, 27).  In 
humans, 13 minutes of tDCS resulted in an increase in excitability up to 150% and lasting 90 
minutes (28).  Research with tDCS has revealed  that  anodal  stimulation can  induce  transient  
(on the order of 30 minutes)  improvements in performance on cognitive, motor and  linguistic  
tasks (2, 29, 30). For example, anodal tDCS to dorsolateral prefrontal cortex elicited an 
improvement in working memory (31); stimulation to primary motor cortex improved motor 
learning and motor control (18, 30); tDCS  delivered  to  primary  motor  area  or  to visual  area  
V5  induced  improvements  in  visuo-motor  coordination (32);  anodal stimulation of fronto-
polar  regions improved  probabilistic  classification  learning (29);  and left prefrontal  cortical  
stimulation  lead  to  increased  verbal fluency (9). Cathodal stimulation decreases cortical 
excitability in humans - i.e., affected neurons will be less likely to fire (19). So there is gathering 
evidence that attests to the efficacy and safety of tDCS both in healthy participants and in 
individuals with stroke. The potential  for therapeutic applications in stroke recovery is obvious. 
 
More recently, tDCS has been applied in combination with post-stroke aphasia therapy and 
yielded promising results including improved word-retrieval, repetition, verbal fluency, and 
better cohesion of verbal narratives.  Marangolo et al. reported that for individuals with aphasia, 
1mA of anodal tDCS to the left inferior frontal gyrus during intensive language training 
significantly improved verbal repetition (8) and expression of cohesive ties (pronouns, ellipses, 
word repetitions, conjunctions) during a verbal narrative task (10). Baker, Rorden & Fridriksson  
demonstrated that in individuals with post-stroke aphasia, 1mA of anodal tDCS to the left frontal 

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cortex administered during 5 consecutive days of computerized anomia therapy significantly 
improved naming accuracy as compared to a therapy-matched sham stimulation condition (4).  
Interestingly, they found that participants with the greatest improvement in naming accuracy 
were those with intact perilesional tissue closest to the activation site of the tDCS anode.  
Moreover, Fiori et al. (2011) showed that 1mA of anodal tDCS over left Wernicke’s area 
significantly improved both reaction time and non-word verbal learning in healthy controls, and 
real word retrieval individuals with aphasia (2).  Response accuracy and reaction time 
improvements of the aphasic group remained robust at follow up (1 and 3 weeks post), indicating 
potential for long-term recovery.  Overall, these recent studies specifically on recovery of 
aphasia suggest that tDCS in combination with standard therapy is a potentially powerful tool for 
enhanced  recovery of language in individuals with aphasia.   
 
However, stimulation parameters vary substantially between aphasia studies, warranting further 
investigation.  Specifically, timing of stimulation may play a key role in performance.  While  
some investigators demonstrated significant naming accuracy improvements in individuals with 
aphasia who received 1mA of anodal tDCS during intensive language therapy (2, 4), others 
showed that  the greatest improvement occurred when anodal tDCS preceded training  (11). 
 
Based on these results, the present study will examine the effect of anodal tDCS before language 
treatment using an approach that has previously been used concurrently with language treatment 
in order to determine the most effective timing parameters for stimulation applied with aphasia 
interventions (4).  
          
Research Design and Methods 
 
Inclusion/Exclusion Criteria 
Inclusion Criteria:  
1. ≥ 18 years of age 
2. First single focal unilateral left hemisphere lesion with diagnosis verified by brain 
imaging (MRI or  CT  scans)  that  occurred  at  least  6  months  prior   
3. Pre-morbidly right handed 
4. Pre-morbidly fluent English speaker 
5. Cognitive  function sufficient  to  understand  the experiments  and  follow  instructions  
(per interview with Speech Pathologist) 
6. A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western 
Aphasia Battery (neither completely without language comprehension/expression nor 
fully recovered from aphasia). 
 
Exclusion Criteria:  
1. Ongoing use of CNS-active medications  
2. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and  anti-
psychotic medications  
3. Presence of additional potential tDCS risk factors:  
 Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor 
nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)  

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 Presence of an electrically, magnetically or mechanically activated implant  
(including cardiac pacemaker), an intracerebral vascular clip, or any other electrically 
sensitive support system  
 Metal in any part of the body, including metal injury to the eye (jewelry must be 
removed during stimulation)  
 A history of medication-resistant epilepsy in the family  
 Past history of seizures or unexplained spells of loss of consciousness during the 
previous 36 months 
4.      Pregnancy in women, as determined by self-report 
 
Visit Schedule 
In this pilot study, 24 participants will be accepted from our referral sources in the department of 
Neurology and Physical Medicine. There will be 2 measurement periods before the training 
starts, separated by 3-14 days in order to establish baseline word-finding performance on 
selected trained and untrained word lists.  Following the lead-in period, subjects will participate 
in a cross-over design training period to compare the two tDCS conditions (1mA anodal vs. 
sham).  The training portion of the study will occur over a total of 3 weeks.  During that time, 
subjects will attend five consecutive, 60-minute training sessions under treatment condition one 
(anodal vs. sham tDCS), followed by a 1 week rest interval, and then another five consecutive 
sessions of training under treatment condition two.  Order of training word lists and tDCS 
stimulation condition will be counterbalance across participants.  Subjects will undergo four 
additional evaluations throughout the course of the study, two of which will occur immediately 
after each of the training conditions (discharge), and the other two of which will occur 1 week 
after each training condition (follow-up).  All study procedures will be administered or 
supervised by the research coordinator or another licensed Speech-Language Pathologist. All 
visits will be conducted in the clinical robotics and non-invasive brain stimulation suite at the 
Feinstein.  
 
Lead-in Period 
 Week 1, Visit 1  (approximately 60 minutes)  
 Baseline outcome measures 
 Medical screening 
 Consent  
 Week 2, Visit 2  (approximately 60 minutes each) 
 Baseline outcome measures 
 
 
Training Period Phase I 
 Week 3, Visit 3-6 (approximately 60  minutes) 
 20 min of stimulation condition 1 (sham or anodal tDCS) and 20 min of 
computerized word-picture matching therapy 
 Week 3, Visit 7 (approximately 90 minutes) 
 20 min of stimulation condition 1 (sham or anodal tDCS) and 20 min of 
computerized word-picture matching therapy 
 Condition 1 discharge outcome measures 
 

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Follow Up Testing Phase I 
 Week 4, Visit 8 (approximately 60 minutes) 
 Condition 1 follow-up outcome measures 
 
Training Period Phase II 
 Week 5, Visit 9-12 (approximately 60  minutes) 
 20 min of stimulation condition 2 (sham or anodal tDCS) and 20 min of 
computerized word-picture matching therapy 
 Week 5, Visit 13 (approximately 90 minutes) 
 20 min of stimulation condition 2 (sham or anodal tDCS) and 20 min of 
computerized word-picture matching therapy 
 Condition 2 discharge outcome measures 
 
Follow Up Testing Phase II 
 Week 6, Visit 14 (approximately 60 minutes) 
 Condition 2 follow-up outcome measures 
 
 
 
Schedule Chart 
  
Screen 
1 
Screen 
2 
Tx Condition 1 
Cond 
1 FU 
Tx Condition 2 
Cond 2 
FU 
  
Visit 1 
Visit 2 
Visit 3-
6 
Visit 
7 
Visit 
8 
Visit 9-
12 
Visit 
13 
Visit 14 
Informed 
Consent 
X 
  
  
  
  
  
  
  
Medical Hx 
X 
  
  
  
  
  
  
  
Medical FU 
  
X 
  
  
  
  
  
  
Demographic 
Info 
X 
  
  
  
  
  
  
  
Inclusion 
Criteria 
X 
  
  
  
  
  
  
  
Neurological 
Exam 
X 
  
  
  
  
  
  
  
Medication 
check 
X 
  
  
  
  
  
  
  
Outcome 
Measures 
X 
X 
  
X 
X 
  
X 
X 
tDCS and 
Aphasia tx 
  
  
X 
X 
  
X 
X 
  
 
 

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Clinical Outcome Measures 
 
Naming Probes (Primary Measure): 
Picture naming accuracy will be assessed across two word lists, which were developed in a 
previous study (4).  Each word list is comprised of a total of 75 trained and untrained nouns, 
which are controlled for word-frequency, semantic content, and word length, and depicted with 
color pictures presented on a laptop.  Subjects will be provided with a different word list for each 
condition (sham vs. anodal tDCS), and asked to name each picture as soon as they see it. 
Responses will be audio/visually recorded for later transcription and scoring by an SLP.  The 
first complete response will used to determine the accuracy score.  The outcome measure will be 
change in naming accuracy of trained items (task learning) and untrained items (learning 
generalization) in each condition.     
 
Aphasia Battery (Secondary Measures):   
A set of brief subtests from larger aphasia batteries will be used to asses changes in verbal 
expression and fluency in subjects with chronic expressive aphasia.  Audio/Video recordings will 
be made of speech-language assessments for review and scoring by approved clinicians.   
-“Diadochokinetic Rate” and “Increasing Word Length,” subtests of the Apraxia Battery 
for Adults (ABA-2): The ABA-2 is a valid and reliable measure of changes in motor 
speech across isolated speech sounds, multisyllabic utterances, and connected speech 
samples.  Together, these subtests take approximately 5 minutes to administer and derive 
an apraxia impairment profile score (42, 45, 46). 
-Generative Naming:  Generative Naming is a commonly used clinical measure of verbal 
fluency and semantic memory in individuals with aphasia.  It has been used frequently in 
the tDCS literature as a sensitive metric of changes in verbal fluency (38, 39, 43).  
-Philadelphia Naming Test short form (PNT): The PNT is a valid and reliable measure of 
changes in expressive naming across time in stroke patients with expressive aphasia.  
Performance on the PNT short form has been statistically correlated to PNT long form 
performance for individuals with aphasia (40, 41, 42). 
-Connected Speech Sample including the “Cookie Theft” or “Birthday Party” picture 
descriptions: Connected speech samples are frequently used metrics of changes in rate, 
fluency, and language formulation in individuals with aphasia.  Audio/visual recordings 
of naturalistic language samples allow for independent quantitative scoring of language 
function by clinicians (45, 46).   
-“Symbol Cancellation” subtest of the Cognitive Linguistic Quick Test (CLQT): is a 
valid and reliable non-verbal, visual cancellation task.  It is frequently used by clinicians 
in aphasia literature as a non-verbal control task of attention and visual memory (43).  
-Western Aphasia Battery Revised (WAB-R):  The WAB-R provides an aphasia quotient 
for type and severity of aphasia, and is commonly used in the aphasia literature.  Changes 
of >5 points are clinically significant (42, 44, 45).  
 
 
Transcranial Direct Current Stimulation (tDCS) Application: 

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Patients will sit in a comfortable chair and a plastic band will encircle the skull. An electrode – a 
flat 5X5cm plate – will be ensheathed in a disposable cotton sponge and held in place by the 
band. The reference electrode (cathode) covered by the pad will be placed on the right shoulder 
and another electrode (anode) will be placed over Broca’s area (left posterior inferior frontal 
gyrus).  To locate the optimal cortical region of the left frontal cortex to be stimulated by the 
anode electrode, tDCS current modeling of each subject’s MRI will be performed.    
 
A 1mA current will be delivered using the surface rubber-carbon electrodes (35cm2)  with  
surrounding  saline  soaked  sponges  (0.9%  NaCl)  by a battery  driven,  constant  current  
stimulator  (maximum  output  2mA) (51). Participants will receive stimulation for 20 minutes 
while seated (prior to language training), with the anode over the left frontal cortex and  the  
cathode  on the right shoulder. Sham tDCS: comparable set-up to real tDCS, 30 seconds real 
current ramping to 1mA at commencement, then after 5 seconds a slow decrease but no current 
sustained for 20 minutes. 
 
Computerized Anomia Treatment: 
This self-administered computerized anomia treatment was reported on in a previous study, and 
demonstrated to be helpful in improving naming accuracy of individuals with aphasia (4).   
Subjects are asked to perform a 20-minute picture-word matching task following receipt of either 
sham or anodal tDCS. 
 
Randomization  
A single-subject cross-over design will be used to compare two tDCS conditions (1mA anodal 
vs. sham).  The order of anodal or sham stimulation will be counterbalanced across participants, 
and determined using a random number generator. 
 
Blinding 
This is a double blind study.  The tDCS device will be covered such that the administrator will 
code each stimulation condition as either switch “up” or switch “down,” but will remain blinded 
to which code is anodal vs. sham stimulation.  In this way, all investigators interacting with 
patients will remain unaware of stimulation condition.  For the sham condition, the stimulation 
automatically ramps down after 30 seconds because the perceived sensation of tDCS on the skin 
has been reported to fade after this period (21).  Consequently, participants will also stay blinded 
to stimulation condition.   
 
Statistical Considerations and Data Analysis 
 
SPECIFIC AIM 1: To evaluate whether anodal tDCS preceding aphasia therapy significantly 
improves picture naming in individuals with post-stroke aphasia. 
 
Methods to address specific aim 1: A Wilcoxon signed-rank test will be used to compare 
naming accuracy scores pre and post anodal tDCS condition across participants. 
 
SPECIFIC AIM 2: To compare naming performance between intervention conditions (tDCS 
and sham stimulation).     
 

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Methods to address specific aim 2:  If neuromodulation preceding treatment is effective for 
promoting recovery in language impairment, as it is in robotic hemiplegia treatment, we expect 
the improvement in naming accuracy to be greater following anodal tDCS compared with sham 
tDCS. This will be examined with a 2x2 repeated measures ANOVA for both treated and 
untreated items with stimulation type (A-tDCS,S-tDCS) and time (T1, T2) as factors. 
 
SPECIFIC AIM 3: To compare naming performance between severity groups (high vs. low 
functioning aphasia as determined by admission Western Aphasia Battery scores (WAB)). 
 
Methods to address specific aim 3:  This will be examined with a 2x2 repeated measures 
ANOVA with change in naming performance in each stimulation condition (change in naming 
performance A-tDCS vs. S-tDCS) and severity level (high vs. low functioning aphasia). 
 
 
Protection of Human Subjects 
 
RISKS TO SUBJECTS 
 
Human Subject Involvement and Characteristics:  We anticipate enrolling 12 human 
subjects. Inclusion and exclusion criteria are stated above in the Research Design and Methods 
section.   
 
Sources of Material:  Sources  of  research  material  will  be  the  hospital  records  providing  
demographic  and  medical information  including  CT  or  MRI  imaging  studies,  and  clinical  
examinations  performed  at  outpatient facilities run by the Department of Physical Medicine 
and Rehabilitation of the North Shore University Hospital (NSUH) and LIJ Medical Center 
(LIJMC), or copies of medical records from outside hospitals provided by participants.  
 
Potential Risks:   
tDCS Risks: tDCS is a safe technique that poses a non-significant risk to participants. The safety 
of this technique has been addressed and tested by multiple researchers (16, 18, 20, 33-34) who 
have concluded that tDCS, as applied in a manner similar to our proposed protocol has no long-
term negative side effects.  More than 30 research studies involving hundreds of participants 
have been published using tDCS. Hundreds more participants have undergone tDCS for 
unpublished pilot research.  No undesirable or long-lasting effects have been reported, nor have 
any participants reportedly abandoned a study due to discomfort.   
 
Researchers at the National Institute of Neurological Disorders and  Stroke  (NINDS) conducted 
a safety study on tDCS, investigating 20-minute sessions of 1 mA and 2 mA current stimulation  
with healthy controls (n=103) (20). No negative effects were identified.  Nitsche  and  colleagues 
(2004)  found  no  measurable  structural  changes  in  brain  tissue  due  to  tDCS (23).  
Additionally, studies have shown that tDCS can be used safely in stroke patients (11, 18, 34-37). 
Thus, a growing body of research from different laboratories has shown that tDCS is a safe, non-
invasive  and  painless  technique  for  modulating  neural  excitability,  with  measurable  but 
only transient effects. The protocol described here uses stimulation levels that fall well within 
safety limits established  by  basic  research  investigating  neural  tissue  damage,  as  well  as  

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numerous  studies applying  tDCS  with  human  participants (22-24). tDCS  has  the  potential  
to  cause  erythema –  redness  of  the  skin  that  is  uniform  or  mottled  around the  area of 
stimulation.  The reddening has been found to be transient for level of stimulation proposed in 
this protocol (20-21).  
 
Confidentiality Risk: One additional risk concerns the risk to confidentiality incurred with any 
collection of medical data.  
 
ADEQUACY OF PROTECTION AGAINST RISKS 
 
Recruitment and Informed Consent:  Stroke subjects who meet inclusion criteria and do not 
meet exclusion criteria will be recruited by consenting professionals through the Department of 
Physical Medicine and Rehabilitation of NSUH and LIJMC.  Recruitment will be done with 
direct contact and flyers.   
 
Northwell Health Health  physicians and clinicians who have appropriate patient populations will 
be made aware of the research study protocol and procedures, and given an overview of the 
study through contacts with the study personnel.  These clinicians will identify potential study 
participants.  If the patient expresses interest in participation, the clinician will either: 1.) provide 
the patient with the study coordinator’s contact information or 2.) provide the patient’s contact 
information to study personnel. 
 
Investigators may contact (or be contacted by) a potential subject or subject’s LAR/next-of-kin 
by telephone to discuss participation in this research protocol. The investigator will provide the 
subject/LAR/next-of-kin with all the information contained in the written consent form. The 
investigator will answer any questions regarding the research and give the subject/LAR/next-of-
kin ample time to consider participation in the study which may require a follow-up phone 
conversation.  
 
After a discussion about the study with a potential subject and/or a potential subject’s legally 
authorized representative (LAR)/next of kin, interested parties will be given a copy of the 
consent form by one of the study investigators.  The investigator will review and explain the 
consent form.  All information about the study will be provided.  Ample time will be given for 
individuals to ask questions regarding participation and to have questions answered prior to 
signing the consent form.  If so desired, those interested will be given a copy of the consent form 
so that they may have the opportunity to discuss participation further with family and/or 
advisors.  Only those investigators listed in the study protocol will obtain informed consent.  If 
an individual chooses to enroll, the consent form will be signed before participation begins.  
Once an individual joins the study and informed consent is obtained, the subject will receive a 
signed copy of the consent form. The subject may withdraw from the study at any time without 
repercussions to subsequent care.   
 
If the patient is awake, alert, and oriented to person, place, and time, and demonstrates 
appropriate cognitive and communicative abilities as determined by the study coordinator or PI, 
the patient will be deemed to have the appropriate capacity to consent; however, given that 
borderline cognitive dysfunction and/or aphasia may not be easily distinguishable, the patient’s 

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LAR/next of kin will be routinely included when consent to participate is being obtained for all 
subjects. 
 
If it is determined that a patient is unable to consent for him/herself, due to a lack of capacity or 
lack of comprehension, consent will be sought from the patient’s LAR/next of kin.  Assent of the 
adult subject with LAR/next-of-kin will be obtained as appropriate.  If such a subject regains 
his/her ability to make healthcare decisions, he/she will be given the opportunity to provide 
consent.   This consent will be documented using the Addendum to Consent by Research Proxy 
for Continuing Participation in a Research Study form. 
 
If the patient provides the consent delegate with assent to participate in the research but, due to a 
physical disability, is unable to sign the consent form, the patient will provide verbal consent and 
two witnesses and the patient’s LAR/next of kin will sign the document affirming their presence 
during the consent process and the patient’s physical disability as reason for an absent signature. 
 
 
Protection Against Risk:   
 
Protection against tDCS-related risks:  If any redness is apparent where the electrodes were 
placed, a cold compress will be offered to the subject. We will monitor subjects continually 
during the stimulation period, and will be in constant contact with the subjects.  The study can be 
immediately stopped at the subject’s request.  
 
Protection of Confidentiality: To protect subjects’ confidentiality, each subject will be assigned 
an ID number, and all data will be stored with the subject ID number only and not the subject’s 
name. Data will be stored on a password-protected computer and on Feinstein’s data server, 
REDcap. The Feinstein Institute for Medical Research will be used as a central location for 
data processing and management. Vanderbilt University, with collaboration from a 
consortium of institutional partners, has developed a software toolset and workflow 
methodology for electronic collection and management of research and clinical trial data. 
REDCap (Research Electronic Data Capture) data collection projects rely on a thorough 
study-specific data dictionary defined in an iterative self-documenting process by all 
members of the research team with planning assistance from the Biostatistics Unit of the 
Feinstein Institute for Medical Research. The iterative development and testing process 
results in a well-planned data collection strategy for individual studies. REDCap servers are 
housed in a local data center at the Feinstein and all web-based information transmission is 
encrypted. REDCap was developed specifically around HIPAA-Security guidelines and is 
recommended to Northwell Health researchers by both our Clinical Research Service, 
Research Compliance Office and Institutional Review Board. REDCap has been disseminated 
for use locally at other institutions and currently supports 965 active institutional partners 
and other institutions in 78 countries (www.project-redcap.org)Subject charts with medical 
history and assigned subject numbers will be kept in locked file cabinets stored at the Feinstein 
robot suite. Access to charts will be granted only to study investigators.  Charts will be kept 
confidential and will not be shared with any third parties without permission from the subject.  
Any study data containing PHI that is transferred between investigators at Feinstein and 
collaborating institutes will be shared via encrypted email or encrypted storage drives. 
 

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Data and Safety Monitoring:  To protect both the integrity of the data and the safety of all study 
participants, study data review in aggregate will occur every 4 months by the Principal 
Investigator.  
 
POTENTIAL BENEFIT TO SUBJECTS AND OTHERS 
The  risk/benefit  ratio  is  very  low  in  the  proposed  study  due  to  the  established  safety  of  
the  protocol and to the great potential for using the findings to improve rehabilitation methods.   
 
SCIENTIFIC VALUE 
The results of this study may help to improve rehabilitation of post-stroke aphasia. 
 
REFERENCES 
 
1. 
National Institute of Neurological Disorders and Stroke, and National Stroke Association 
Aphasia Statistics 2008 as cited at the America Speech-Language-Hearing Association, 
www.asha.org  
2. 
Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, 
Tomaiuolo F, Marangolo P.  Transcranial direct current stimulation improves word retrieval in 
healthy and nonfluent aphasic subjects. Journal of  Cognitive Neuroscience. 2011; 23(9):2309-
23. 
3. 
Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari 
M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. 
Journal Neurology, Neurosurgy, & Psychiatry. 2008;79(4):451-3.  
4. 
Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat 
stroke patients with aphasia. Stroke. 2010;41(6):1229-36.  
5. 
Fridriksson J, Richardson JD, Baker JM, Rorden C. Transcranial direct current 
stimulation improves naming reaction time in fluent aphasia: a double-blind, sham-controlled 
study. Stroke. 2011; 42(3):819-21.  
6. 
Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. 
Transcranial direct current stimulation (tDCS) and language. Journal of Neurology, Neurosurgy, 
and Psychiatry. 2013; 84(8):832-42. 
7. 
Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 
2012; 26(9):1169-1191.  
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