Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia
Phase: NA
Conditions: Aphasia
Sponsor: University of Michigan

Brain stimulation in aphasia 
NCT03510182 
May 10, 2018 
 
 

PROTOCOL FOR HUM00108213: Brain stimulation in aphasia 
Research Design 
5-1.1 Objective 
This project will focus on treating aphasia with tDCS in conjunction with language therapy. 
5-1.2 Specific Aim/Hypothesis 
We are interested in determining if and how tDCS can be used as a tool to improve language 
ability in aphasic patients when used in conjunction with language therapy. We would like to 
assess the patient-specific parameters under which tDCS is effective: specifically, whether 
factors like lesion size and location, aphasia severity and type, and time post-stroke influence the 
efficacy of tDCS with language therapy.  
5-1.3 Background Information 
There has been research to support the idea that tDCS can have beneficial effects on aphasia 
when applied to the left hemisphere, typically around Broca’s area (Aguiar, Paolazzi, & Miceli, 
2015). These effects have been observed in studies with tDCS administered for ten minutes 
(Baker et al., 2010) to thirty minutes (Lee et al., 2013), over one session (Rosso et al., 2014) to 
ten sessions (Galletta & Vogel-Eyny, 2015; de Aguiar et al., 2015) with non-fluent (Campana, 
Caltagirone, & Marangolo, 2015; Shah-Basek et al., 2015) and fluent aphasics (Jung et al., 2011; 
Fridriksson et al., 2011). Although tDCS is often beneficial, there is a need for a targeted 
approach to assess the stimulation-specific and patient-specific parameters under which tDCS is 
a successful tool. Additionally, studies using tDCS in aphasic patients have not employed 
traditional language therapy in their sessions; instead, they often target one outcome like word 
retrieval (Baker et al., 2010; Floel et al., 2011; Fiori et al., 2011). Limited work has been done to 
determine whether stimulation can improve outcomes with traditional therapy. 
5-1.5 Methodology 
Subjects will be recruited from the University of Michigan Aphasia Program. In this clinical 
program, clients undergo intensive language therapy over four weeks which includes a 
combination of individual therapy (about 14 hours a week), group therapy (about 6 hours a 
week), and computer-based therapy (about 5 hours a week). This project will consist of tDCS 
sessions administered during the course of this clinical care. Subjects will receive up to 30 
sessions of active tDCS over the left hemisphere while undergoing individual behavioral therapy. 
The standard numeric analogue scale used for pain in UMHS with the addition of faces on a 
scale of 1 to 10 will be placed in front of the client to allow them to communicate any discomfort 
they may feel and if they would like to stop the study.  
5-1.6 Statistical Design 

We will compare the baseline performance of subjects to their performance after tDCS in 
conjunction with language therapy, including specific measures of word fluency and naming. We 
have data collected from a group of 300 subjects who received the same type of therapy without 
tDCS which we can use as a “control group” to compare the effect of therapy alone to the effect 
of therapy with tDCS. We will also assess subject parameters as they relate to their performance, 
including age, time post-stroke, type and severity of aphasia, location and size of lesion, and 
other relevant variables. If possible, we will also have follow-up meetings with the subjects 
either 4 weeks post-therapy or 8 weeks post-therapy to see how long improvement is maintained. 
Participants 
Recruitment: Clients who are participating in the University of Michigan Aphasia Program and 
meet study criteria will be invited to join this study. Clients who are identified by the Dr. Persad 
as a potential subject, will first be asked if they would like to hear about the study from a 
member of the research team. If the patient consents, then the member of the research team will 
meet with the patient and a family member if present to discuss the study. Only subjects with 
aphasia will participate in this study.  
Inclusion criteria: Chronic receptive or expressive aphasia with or without apraxia. 
Exclusion criteria: Any implanted devices or surgical instruments, history of severe mental 
illness or epilepsy, no active history of seizures (within three months). As the risks to pregnancy, 
are unknown, no pregnancy or plan to become pregnant during the study period will also be an 
exclusion criteria. 
tDCS 
Parameters: All subjects will receive up to 30 sessions of active tDCS. Depending on the 
availability of the subject, the session number may vary from 15 to 30 sessions. Each session will 
begin with up to 20 minutes of active tDCS at 2mA in conjunction with the individual behavioral 
therapy. The anode electrode will be placed over the left hemisphere and the reference electrode 
will be placed on the contralateral frontopolar cortex. The specific montage will be determined 
based on individual patient characteristics.  
Risks: tDCS is generally considered safe with no more than minimum risk. In a meta-analysis of 
over 200 tDCS studies conducted from 1998 to 2010, 56% of studies mentioned adverse events 
(Brunoni et al., 2011). The available evidence suggests that it is safe. However, it is 
investigational in nature, which means that we are doing these studies to learn more about 
tDCS.  The most common side effects associated with tDCS based on the available scientific 
data are:  
Sensations under the electrode: These sensations usually stop shortly after tDCS begins but can 
sometimes continue throughout and for a brief period after tDCS.  

• Mild tingling • Light itching • Slight burning sensation • Discomfort  
Effects reported that occur ONLY during tDCS: 
• Visual sensation during switching on and off the stimulation 
Other effects that can occur both during and after tDCS include: 
• Fatigue,  
• Skin redness  
 • Headache   
• Changes in concentration, memory, or other cognitive abilities. This is partially what we 
will be testing. 
Additionally the following rare side effects have been described in previous studies that used 
tDCS: 
• Nausea   
• Nervousness  
• It is also possible that the electric current can cause a burn on your skin. This is unlikely 
because we are using a smaller dose than what is known to cause burns and because we 
use saline or gel to reduce electrical resistance that leads to burns.  
• A shock-like sensation at the initiation of tDCS was reported in one participant.  
• Changes in the activity of the prefrontal region (front of the head) have the potential to 
induce sudden changes in your mood. Hypomania has been reported in a few patients 
receiving tDCS for bipolar disorder and depression but never in normal controls. 

Subjects with a history of bipolar disorder will be excluded from the study. At this time, tDCS 
has never been reported to cause a seizure in any patient population. Seizures are, however, 
theoretically possible and a seizure plan is in place for such an unlikely event. Importantly, the 
majority of the above side effects have been also reported in association with sham (fake) tDCS, 
even with similar rates. The table below comes from a recent review of tDCS safety and shows 
the percentage of studies reporting these common sensations (Brunoni et al., 2011) These data 
suggest that other factors may cause these sensations, such as your expectations or the pressure 
of head straps or caps. 
 
 
 
 
Due to the investigational 
nature of this 
study, there may be risks, 
discomforts or 
side effects that are not yet 
known. 
 
We will follow 
current safety 
guidelines for tDCS and will use a current strength of up to 2mA and a duration of up to 20 
minutes. Few, if any, side effects are reported with these parameters (Nitsche & Paulus, 2011). 
We will also monitor subjects for discomfort during and after each session. During the session, 
we will verbally ask the subject if they are experiencing discomfort. The Speech-Language 
Pathologists will be in the room while the stimulation is being applied and will consequently be 
available to assist the patients in communicating any side effects they may be experiencing. 
After the sessions, subjects will complete the following post-tDCS questionnaire: 

 
 
Data Monitoring 
Once a year, a review of participant recruitment procedures and consent forms as well as any 
adverse events will be conducted by a member of Dr. Hampstead’s research team, who is not 
part of this study.