Cognitive Training With and Without tDCS to Improve Cognition in HIV
Phase: NA
Conditions: HIV, Mild Neurocognitive Disorder
Sponsor: Nova Southeastern University

 
PI: OWNBY 
Version Date: 12/2/14 
Page 1 
Nova Southeastern University 
Institutional Review Board for Research with Human Subjects (IRB) 
New Protocol Submission  
 
Center Rep: 
To be completed by IRB Office 
Date Sent to IRB: 
Protocol Number: 
Instructions: In order to comply with federal regulations and with the university's IRB guidelines, the Principal 
Investigator (PI) is required to complete all of the following items. After completing, submit this document and all 
consent forms and research instruments (questionnaires, interviews, etc.) to the appropriate IRB College/Center 
Representative.  You can find your college/center representatives using the following link: 
http://www.nova.edu/irb/membership.html.   
 If your study qualifies for center level exemption from further review, the Center Representative will exempt 
your study, provide you with a memo to that regard, and give you copies of the stamped, approved 
consent/assent form(s), if applicable. The Center Representative will log your study into the IRB database and 
forward a copy of the complete submission to the IRB office. 
 If your study appears to qualify for expedited review, then once the Center Representative believes the 
submission is complete, the Center Representative will log your study into the IRB database and forward ONE 
complete submission packet to the IRB office for review.  
 If full review is required, the Center Representative will log the study into the IRB database and will provide the 
PI with instructions for submitting 2 stapled or rubber banded copies (AND 1 unstapled original) of the 
submission and all supporting materials (research protocol, consent/assent forms, letters of authorization, etc.) 
to IRB.  Please note: ONLY ONE copy of all research instruments (tests instruments, interview protocols, etc.) 
needs to be submitted.  The completed package must be received by the IRB by the last business day of the 
month prior to the next scheduled IRB meeting.  Because mail, including express delivery, takes at least a day 
to be delivered within the university, please make allowance for this in your planning. Incomplete submissions 
will delay review by the IRB.  The IRB reserves the right to postpone review of protocols at convened meetings 
due to needed revisions. 
 
Use a word processor to complete this form.  You do not need to be concerned about where page breaks fall.  You 
are to complete all BLUE sections. Be sure that all pages, including any appendices or attachments, except for 
consent/assent forms and advertisements, are numbered sequentially.  For further information, refer to 
http://www.nova.edu/irb/manual/policies.html and http://www.nova.edu/irb/process.html  
 
Do not approach subjects about being in the research study until you have received NSU IRB approval. 
 Form Version:  August 1, 2013 
 
1. General Information 
1.A. Research Project Title: 
 
 
Cognitive Training with and without tDCS to Improve Cognition in HIV 
 
 
1.B. Insert Principal Investigator’s (PI) Last Name and Date of Submission in the footer.  
1.C. Brief Overview (Max 250 Words): 
 
 
The purpose of the proposed study is to develop pilot data on the potential efficacy of computer-
based cognitive training or the combination of computer-based cognitive training with 
transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-
related mild neurocognitive disorder (MND). tDCS is a noninvasive brain stimulation technique in 
which a small direct current (1-2 mA) is applied to the scalp during a cognitive or motor activity, 
inducing a very small current that affects specific neural circuits related to the site at which 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 2 
electrodes are placed. tDCS has been judged safe and has shown significant treatment effects in 
studies with other populations, but has not been extensively studied in individuals with HIV 
infection. tDCS has been shown to facilitate learning in a number of studies, suggesting that it 
may improve or enhance learning in those with cognitive problems. As HIV infection is 
associated with decrements in a number of cognitive skills, including working memory, executive 
functions, and psychomotor speed that are related to individuals’ functional status and 
medication adherence, the demonstration of a technique to enhance the effects of cognitive 
training in this population would have substantial clinical benefits as well as scientific value. 
 
 
 
 
 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 3 
 
1.D.  Principal Investigator (PI) Information 
Name 
Raymond L Ownby, MD, PhD, MBA 
Relationship to NSU 
Mailing Address 
(for Students) 
 
Interoffice Mail Code 
(for Faculty/Staff) 
COM 
Student 
 
Daytime Phone 
2-1804 
Faculty 
X 
Alternate Phone 
Cell: 954-608-4846 
Staff 
 
NSU Email Address 
Ro71@nova.edu 
NSU Center/College/Dept 
COM 
 
Alternate Email Address 
R_ownby@bellsouth.net 
Degree/Academic 
Information 
MD, PhD, MBA 
PI CITI Completion Date* 
8/19/13 
 
Please briefly describe your applicable professional, educational, employment, professional 
licensure, and research experience.  Do NOT attach your vitae. 
 
Dr. Ownby is Professor and Chair of Psychiatry and Behavioral Medicine in the College of 
Medicine at NSU. He is board certified in adult psychiatry with subspecialty certifications in 
psychosomatic medicine and behavioral neurology/neuropsychiatry. In addition, Dr. Ownby 
trained as a clinical neuropsychologist and is board certified in this psychological specialty. He 
holds licenses for independent practice of both medicine/psychiatry and psychology. Dr. Ownby 
has extensive experience in research and clinical practice in the neurocognitive aspects of 
HIV/AIDS, including previous NIH support for a research study in the area as well as a number of 
related research publications based on this and other research projects. 
 
Specifically with respect to the use of tDCS for this research study, in preparation Dr. Ownby has 
completed two workshops, both two days in length, on the use of tDCS in neuropsychiatric 
disorders. The first completed at Harvard Center for Non-invasive Brain Stimulation at Beth Israel 
Deaconess Hospital in March 2014, included didactic instruction and supervised practice in safety 
issues related to tDCS as well as electrode placement, treatment protocols, and electrical 
stimulation devices. This workshop included supervised use of the FDA-approved Chattanooga 
Ionto electrophoresis device that will be used in this study. A second workshop completed in 
September 2014 at the University of Florida similarly included didactic instruction combined with 
supervised practice in safety issues, electrode placement, and treatment protocols (certificate of 
completion included with this submission). 
 
 
1.E.  Co-Investigators (Co-I) Information (including faculty advisers) 
 
Co-Investigator 1 
Co-Investigator 2 
Co-Investigator 3 
Name 
 
 
 
Mailing Address 
 
 
 
Contact Phone Number 
 
 
 
Email Address 
 
 
 
Degree/Academic 
Information: 
 
 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 4 
CITI Completion Date* 
 
 
 
Please briefly describe applicable professional, educational, employment, professional licensure, 
and/or research experience for all co-investigators.  Do NOT attach vitae. 
 
 
 
 
1.F.  Research Assistant Information (if applicable) 
 
Research Assistant 1 
Research Assistant 2 
Research Assistant 3 
Name 
Rosemary Davenport, 
RN, ARNP 
 
 
Mailing Address 
 
 
 
Phone Number 
2-1804 
 
 
Email Address 
Rd667@nova.edu 
 
 
CITI Completion 
Date* 
8/31/2012 
 
 
 
*NOTE: CITI must have been completed within the last 3 years.  If a member of the research team is affiliated with 
another institution, please include a copy of that individual’s training certification.  

 
PI: OWNBY 
Version Date: 12/2/14 
Page 5 
 
1.G.  Funding Information 
Funding status 
Unfunded 
 
 
Funding Applied For 
 
 
Funded 
X 
 
If you indicated “Funded” or “Funding Applied For,” complete the following. 
Source of Funding 
Principal Investigator’s Research Incentive account 
Project Title (if different from above) 
N/A 
Principal Investigator (if different from above) 
N/A 
Type of Application 
Grant 
 
 
Subcontract 
 
 
Contract 
 
 
Fellowship 
 
 
Award Amount: 
Funds sufficient to provide participant compensation 
as described below are available. 
 
 
1.H. Management of Conflict of Interest 
Read the financial conflict of interest policy at http://www.nova.edu/irb/manual/forms/significant-
financial-interest.pdf 
 
I certify that I, as PI, have read this policy, and have verified that my co-
investigators and research assistants also have read this policy.    
 
For studies that are funded by a governmental agency (any federal, state or local governmental 
entity that has promulgated regulations or policies requiring investigator financial disclosure or 
requiring institutional conflict of interest policies relating to award of grants or contracts) read the 
Office of Sponsored Program’s Financial Conflicts of Interest in Sponsored Programs policy. 
 
I certify that I, as PI, have read these guidelines, and have verified that my co-investigators and 
research assistants also have read these guidelines.    
 
 
 
Do any investigators have a significant financial interest, as defined in the above 
referenced policy, in relation to this study?  
 
If yes, please describe the nature of the conflict of interest below 
 
 
If you answered yes, please be sure to include the following statement, or a similar statement, 
within the description section of the consent forms: “The principal investigator and/or co-
investigator(s) of this research study have a significant financial interest as it relates to this study.”  
Continue, describing the conflict in the consent/assent documents.  
PI Initials 
 
PI Initials 
 
Yes  
 
 
No 
 
 
 
1.I. Dates and Phases of Study 
Proposed Start Date 
Shortly after IRB approval  
 
Other (list date) 
 
Proposed Duration of Research (including analysis of the results) 
One year or less 
X 
 
Other (describe, please note minimum annual continuing review required) 
 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 6 
Is this a multi-part study?  
 
If “Yes,” please note that procedures used in later phases may affect the review status 
of this study.  Briefly describe the later stages. 
 
 
 
Yes  
 
 
No 
X 
 
 
1.J.  Multiple Site Information 
Will the study be conducted at an NSU location?   
 
 
Yes  
X 
 
No 
 
 
If “Yes,” provide the location within NSU, e.g. department or clinic. 
 
 
The study will be completed in Dr. Ownby’s research offices located in Suite 3542 of University 
Park Plaza. 
Will the study involve any NSU faculty, staff or students as subjects? 
 
Yes  
 
 
No 
X 
 
Will the study be conducted at a non-NSU location? 
 
Yes  
 
 
No 
X 
 
Will any of the activities be done online or via telephone (e.g., completion of surveys, delivery of 
instructional content)?  
 
Initial participant contact and screening may be completed by telephone. 
 
If “Yes”, for the Internet based activities, will these be done via a secure site?  
 
No Internet activities. 
 
Yes  
X 
 
No 
 
 
Yes  
 
 
No 
 
 
If “Yes,” please complete the following for the non-NSU sites.  
Include these sites on the consent form in the “site information” section. 
 
Site 1 
Site 2 
Site 3 
Site Name 
 
 
 
Address 
 
 
 
Phone Number 
 
 
 
You will need documentation of permission to conduct the research at non-NSU sites.  Attach the 
permission letter(s) or IRB approvals to this document. 
 
1.K.  Cooperative Research 
Cooperative research projects are those that involve more than one institution or when an 
investigator is employed at or is an agent of an institution other than NSU,  (For more information, 
see http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html ). Each participating 
institution is responsible for safeguarding the rights and welfare of human subjects and for 
complying with all regulations.  

 
PI: OWNBY 
Version Date: 12/2/14 
Page 7 
Does this research involve cooperative research?   
 
 
Yes  
 
 
No 
X 
 
Has this proposal been submitted or will the proposal be submitted to another Institutional Review 
Board (or authorizing individual, entity, or ethics review board) for review? 
 
Yes  
 
 
No 
X 
 
If “Yes,” please complete for each site.  Please attach documentation of approval.   
(Copy the section of the table and add if there are multiple sites.) 
Name of Institution 
N/A 
IRB/Administrative Decision (check applicable) 
Approved 
 
 
 
Submitted 
(not yet approved) 
 
 
Not yet 
submitted 
 
 
NSU IRB approval required prior to 
submission 
 
 
Date of 
Review 
 
 
Contact Person 
 
Phone Number 
 
 
Level of Review (if IRB Reviewed) 
Exempt 
 
 
Expedited 
 
 
Full 
 
 
 
 
2. Subject/Participant Information  
2.A. Overview of Proposed Subjects/Participants 
(complete all that apply and provide maximum number proposed within each category): 
Subject Group 
Fetus in Utero/ 
non-viable 
fetuses/ 
abortuses 
Newborns 
or 
Infants 
Children 
(aged 2-6) 
Children 
(age 7-12) 
Adolescents 
(aged 13-17) 
Adults 
(18+) 
Pregnant 
Women 
Adults 
with 
Guardians 
Mark X for 
each proposed 
subject type  
 
 
 
 
 
X 
 
 
# of Proposed 
Subjects* 
 
 
 
 
 
32 
 
 
Please briefly describe your potential subjects: 
 
 
Participants will be HIV-infected individuals 18 years of age and older with HIV-associated Mild 
Neurocognitive Disorder (MND) as determined by their scores on neuropsychological tests and 
self-report of cognitive problems. Standard diagnostic criteria known as Frascati criteria have 
been developed and will be followed (Antinori et al., 2007) in selecting participants. These criteria 
require that the patient have memory complaints and below average performance on several 
neuropsychological measures. The degree of cognitive impairment this represents is not 
sufficient to impair potential participants’ ability to understand procedures, potential risks and 
benefits, and to provide informed consent. 
 
*By proposed subjects, the IRB means subjects who will consent to be in the study and begin the study activities. 
 
2.B.  Subject Vulnerability  
Do any subjects have limited decision-making autonomy, have communication problems that would 
limit ability to dissent to study procedures, belong to a group that is vulnerable to 
coercion, or belong to a group defined by regulation as requiring greater care? 
Yes  
 
 
No 
X 
 
If you indicated “Yes”,  please mark with an X next to each applicable category in the 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 8 
column to the right and complete the remainder of this section 
Prisoners 
 
Pregnant Women 
 
Cognitive impairment or emotional problems that potentially limit decision making 
 
Communication impairments that may preclude communicating a decision to discontinue 
participation or refuse participation 
 
Students of the investigator or investigator’s department  
 
Employees of the investigator or investigator’s department 
 
Children (minors) 
 
Terminally ill 
 
Other (specify): 
 
 
 
If you indicated any of the above, please justify your rationale for including these subjects.   
 
 
 
If you are using potentially vulnerable subjects as described above (infants, children, 
pregnant women/fetuses, terminally ill, decision-impaired, communication-impaired, 
students/employees, or prisoners), does the research create greater than minimal 
risk? 
 
Yes  
 
 
No 
 
 
If your subjects have a vulnerability that arises from their being students in your class or 
department, you will be asked for more information in Section 3.G.  If the subjects have one of the 
other vulnerabilities, please describe proposed safeguards to protect vulnerable subjects. 
 
 
 
If not evident from the researcher qualification information in 1.D. or 1.E., please describe the 
researcher(s) qualifications for working with vulnerable subjects 
 
 
 
 
2.C.  Study Design and Methodology  
Part 1 – Purpose 
 
Please briefly describe the purpose of your study.  Note:  Examples of study purposes are “to determine 
if a new reading intervention program improves 4th graders’ reading scores” or “to survey patients on 
their perception of physical therapy services”. 
 
The primary purpose of this study is to develop pilot data that will be used to demonstrate the 
feasibility of a larger study for which we will plan to seek external funding. We will compare the 
performance of study participants’ on several neuropsychological measures as well as their rate 
of learning on a computer-delivered working memory task in groups randomly assigned to 
receive either sham or true tDCS. 
 
 
Part 2 – Goals and Justification 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 9 
 
Briefly elaborate on the main goals and justification for the study.  Summarize the background, 
rationale, nature, and significance of the proposed research.  Include a brief overview of your prior 
research in the area, or literature that supports the need for this study.  This section should be a brief 
overview, and typically is not more than a few paragraphs in length.  You will be asked about 
procedures and instruments later in the submission. 
 
Survival Has Improved but Cognitive Deficits Persist in Those with HIV. Although advances in 
antiretroviral treatment have resulted in significant improvements in the longevity of patients with HIV 
infection, studies show that cognitive problems continue to develop in these individuals, even with 
successful suppression of viral replication (Heaton et al., 2010; Heaton et al., 2011). Characteristics of 
the cognitive problems associated with HIV infection include deficits in psychomotor speed, working 
memory, learning, and executive function. 
 
Cognitive Training May Improve Cognitive Deficits. Studies with normal elders and those with 
memory impairments show that cognitive skills such as attention, perceptual speed, working memory, 
and executive functions can be improved with training (Ball, Edwards, & Ross, 2007; Loewenstein, 
Acevedo, Czaja, & Duara, 2004), that training effects persist (Willis et al., 2006), and that training can 
generalize to related but different tasks (transfer) such as activities of daily living or other complex 
behaviors (Ball et al., 2007). Similar studies in laboratories and with neurologically impaired patients 
also show training and transfer effects (Cicerone, Levin, Malec, Stuss, & Whyte, 2006; Jaeggi, 
Buschkuehl, Jonides, & Shah, 2011).  A small study and case reports suggest that cognitive training 
has positive effects on cognition and instrumental activities of daily living in persons treated for HIV 
infection (Rourke, 2011; Vance, 2010; Ackerman, Vance, Fazeli, & Ross, 2010). 
 
Transcranial Direct Current Stimulation (tDCS) May Improve Cognition in Impaired Individuals. 
Studies have shown that the individuals performing some cognitive tasks may learn more rapidly and 
perform at higher levels of proficiency after exposure to tDCS during the task. Coffman et al.(Clark et 
al., 2012; Coffman et al., 2012), for example, in a study financed by the US Department of Defense, 
showed that individuals given tDCS significantly improved in threat detection in a computer-based 
combat simulation task. Fregni et al. (Fregni et al., 2005) showed that normal young individuals 
showed improvements in working memory after even brief exposure to tDCS. Boggio et al. (Boggio et 
al., 2006) showed that patients with Parkinson’s disease also showed improvements in working 
memory performance after brief exposure to tDCS; this finding is important in relation to HIV since the 
cognitive deficits that occur in HIV infection are often linked to the same fronto-striatal circuitry 
affected in Parkinson’s. No readily available trial has examined the effects of tDCS on working 
memory in persons with HIV infection, although Vance et al has argued that it may be an effective 
treatment and other authors have noted that depressed patients treated with tDCS may show 
improvements in cognition as well as mood (Loo & Martin, 2012). Further, Martin & Loo have shown 
in healthy participants that the use of tDCS during cognitive training (but not before) enhanced 
learning (Martin et al., 2013), and a similar effect of tDCS on working memory performance is also 
reported by Ohn et al. (Ohn et al., 2008). Cognitive training with tDCS is thus a promising treatment in 
those with HIV-related cognitive problems.  
 
Given the Very Tiny Current, How Does tDCS Work? A reasonable question about tDCS is why 
such a tiny current delivered to the outside of the head can have an influence on neural activity. The 
current used in tDCS studies is 1-2 mA; by contrast, the current used in electroconvulsive therapy, an 
approved treatment for depression, is much larger (800 – 900 mA). Both computer modeling (Bikson, 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 10 
Rahman, & Datta, 2012) and animal studies (Bikson et al., 2004; Rahman et al., 2013) have shown 
that the effects of tDCS may result from subtle changes in neuronal membrane polarization that can 
affect cells’ probability of firing. This effect can be modified pharmacologically (Nitsche et al., 2003), 
with dopamine agonists such as L-dopa increasing the effect (Kuo, Paulus, & Nitsche, 2008) while 
dopamine antagonists (sulpiride) reduce it. The effects of tDCS on motor learning may be mediated 
by its impact on brain-derived neurotrophic growth factor (Fritsch et al., 2010). 
 
Safety of tDCS. tDCS is generally considered safe, based on data from multiple studies (Bikson, 
Datta, & Elwassif, 2009). A recent systematic review completed by the FDA of the safety of 
iontophoresis devices found 25 studies using iontophoresis devices for a variety of indications 
(available for download on the FDA website). The FDA staff review concluded that while incidence of 
adverse events varied widely among studies, “most adverse events were mild and did not require 
treatment. These studies support the safety of iontophoresis devices for these indications.” [pg. 37]. 
Another review of adverse events during multiple studies of tDCS with 102 patients and 567 tDCS 
sessions (Poreisz, Boros, Antal, & Paulus, 2007) showed that the most common effects of tDCS were 
“tingling,” “itching sensation,” “burning sensation,” “pain,” “headache,” and “fatigue.” The frequency of 
these effects varied widely across studies reviewed but no serious events, such as burns, were 
reported. 
 
A recent study of tDCS for depression (Brunoni et al., 2013) that used the same device to be used in 
the proposed study (Chattanooga Ionto), reports safety data for 103 patients. In this study, only the 
adverse effect of skin redness was more common in the active treatment group than in the sham 
tDCS group. No change in cognitive function was seen across groups, but several patients developed 
hypomania and 2 manic episodes occurred (there were similar occurrences of hypomania or mania 
across treatment groups of sertraline, tDCS, or their combination).  
 
Animal data also indicate that tDCS is likely to be safe at the doses currently used in studies of 
cognition and mood. Liebetanz et al. (2009) systematically studied the effects of varying doses of 
tDCS on brain lesions in rodents. Data show that the dose of tDCS that resulted in lesions was two 
orders of magnitude greater than that used in most human tDCS studies (see figure, below). 
 
Finally, the current for tDCS to be used in the proposed study can be compared to that used in 
electroconvulsive therapy (ECT), a widely-accepted noninvasive electrical treatment for depression. 
The current used by FDA-approved ECT devices is typically 800 to 900 mA, again much larger than 
the 1.5 mA current to be used in the proposed study. 
 
These studies as well as those showing the relation of pharmacologic interventions inform the 
inclusion and exclusion criteria for the proposed study. The procedures to be followed in this study 
conform to the safety guidelines discussed by Bikson et al., 2009. 
 
 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 11 
 
 
Evaluation of tDCS dosage vs. histologically-confirmed brain lesions in rats showing 
relation of dose causing lesion to tDCS dosing in humans. 
From: Liebetanz, D et al. (2009). Clin Neurophysiol 120 (1161-1167). 
 
 
 
 
Part 3 – Steps in the Research Study 
 
In the box below, please outline in detail the steps in the research study in order as they will occur 
after consent has been secured.  If there are different requirements for different groups/types of 
subjects within the study, please separate out the steps per group.  Indicate how long the subject 
spends completing the different steps/procedures.  Be specific about the tests given and/or treatments 
used, when they will occur, and their frequency. 
 
1) Potentially eligible participants will be identified based on their cognitive testing results 
and self-report of memory problems during our previous study (“Improving Health Literacy about 
HIV Infection: Phase I & II;” NSU IRB Protocol No. 06120904Exp). Participants will be contacted 
by telephone to determine their interest in the study (participants provided permission to 
recontact about future studies at the time of their participation in the earlier study). 
 
2) During the telephone contact, participants will be informed of the nature of the study, the 
need for a screening visit to determine eligibility, the study’s length, the possibility of being 
randomly assigned to receive mild electrical stimulation to the head, the use of computer-based 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 12 
cognitive training, and the extent of compensation. The interviewer will request verbal consent to 
ask the participant about possible cognitive problems, and the potential participant’s response 
will be recorded.  
 
Those who indicate a willingness to respond on this issue will then be screened for the presence 
subjective cognitive impairment using three questions evaluating possible difficulties with 
memory, cognitive speed, and attention as recommended by the European AIDS Clinical Society 
(listed in telephone screening script in Appendix). If potential participants respond negatively to 
all three questions, they will not be eligible for the study as self-report of cognitive difficulties is a 
key part of the diagnostic criteria for HIV-related Mild Neurocognitive Disorder (MND) (Antinori et 
al., 2007). They will be thanked for their time, asked if they have any questions, and the phone 
call will be ended. 
 
Persons who answer yes to any of the three questions and continue to indicate an interest in 
participating will be informed that that may be eligible for the study, and verbal consent to ask 
additional questions about medical history and medication use will be requested (see telephone 
screening script). If the person meets preliminary evaluation of inclusion and exclusion criteria, 
they will then be informed that they may be eligible for the study but that a final determination will 
require additional screening during an in-person visit with cognitive tests. If the potential 
participant continues to indicate an interest in participating, he or she will be scheduled for the 
eligibility visit. 
 
3) At the eligibility visit, potential participants will be reminded of the study characteristics as 
noted above and the need for them to meet study entry criteria on cognitive and symptom 
measures will again be stated (see eligibility visit flow sheet in Appendix). Verbal consent for 
screening procedures will be requested; participants’ response will be recorded (see eligibility 
visit flow sheet in the appendix).  
 
Participants who continue to meet all study criteria with respect to medical history and 
medication use (see flow sheet) will complete four brief neuropsychological measures (Hopkins 
Verbal Learning Test; Trail Making Test Parts A and B; Wechsler Adult Intelligence Scale Digit 
Span subtest; Grooved Pegboard; all listed below) as well as complete the Center for 
Epidemiological Studies Depression and the Patient’s Own Assessment of Functioning Scale. 
These will take approximately 45 minutes to complete. After completing these measures, they 
will be provided with a break (approximately 5-10 minutes) while the researcher scores the 
measures and determines the potential participant’s eligibility given the evidence of both 
subjective cognitive complaints and objectively below average (at least 1 standard deviation 
below normative performance) on at least two of the measures. If participants are not eligible 
based on their cognitive performance, they will be thanked for their attendance, asked if they 
have any questions, and provided compensation. 
 
Participants who show evidence of below average cognitive performance in two areas assessed 
will be informed that they are eligible to participate in the study. Their continued interest in 
participation will again be elicited, and if they continue to state they would like to participate, the 
investigator will review the written informed consent form with the potential participant, answer 
questions about the study, and provide the potential participant with sufficient time to review the 
written informed consent form. The investigator will then ask the participant to briefly recount the 
purpose of the study as well as its risks and benefits using a previously validated procedure 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 13 
(Palmer et al., 2005). If participants cannot provide adequate answers to these questions, the 
person obtaining informed consent will review the material until they achieve a satisfactory 
performance defined as a score of 4 out of a possible 6 on the three questions (see visit flow 
sheet for questions and scoring criteria). 
 
We will encourage the potential participants to view the computer training room, observe the 
training tasks, and we will plan to show them the tDCS device, electrodes, and headband. If the 
potential participant continues to indicate an interest in the study, at this point he or she will be 
asked to sign the informed consent form.  After the form is signed, the participant will be asked 
to complete the computer-administered measures (questions about mental functioning and mood 
as well as the CES-D depression scale and the Patient’s Own Assessment of Functioning). The 
participant will then be scheduled for the first study visit, provided compensation and allowed to 
return home. 
 
4) At the first study visit, participants will be randomly assigned to one of two treatment 
conditions, computer-based working memory training with true tDCS or sham tDCS. 
(Randomization will be accomplished using randomized permuted blocks of four). All participants 
will be fitted with saline-soaked 25 cm2 sponge electrodes placed at F3 (in the International 10-
20 EEG electrode system; this is about half of the distance of a line drawn between the eye and 
ear, and somewhat above this midpoint) and above the right orbit. This electrode placement is 
believed to allow for stimulation of the left dorsolateral prefrontal cortex known to be a key 
structure in verbal working memory, and has been used in previous studies of tDCS for cognitive 
enhancement. Computer software allows for a simulation of likely current flow using this 
electrode array (see color picture in Appendix); a black and white picture illustrates electrode 
placement (also in Appendix). 
 
Participants receiving active tDCS will then receive 1.5 mA tDCS delivered by the Chattanooga 
Ionto electrophoresis device for 20 minutes while completing working memory training with the 
Brain Workshop software (example computer screens are included in the Appendix). The device 
provides an initial 30 s ramp-up of current so as to minimize discomfort and is designed to 
deliver a constant current even in the face of possible fluctuations in impedance due to changes 
in electrode or skin characteristics (e.g., increased resistance as the electrode dries). It includes 
circuitry that continuously monitors impedance so that if it changes beyond safety parameters 
the device immediately shut off with an audio alarm. This provision reduces risk of participant 
discomfort or other negative effects. The device also is controlled with a timer that guarantees a 
specific dose tDCS; it automatically ramps down the current and shuts off at the end of the 
session (20 minutes). 
 
Participants receiving sham tDCS will be treated in the same fashion (fitted with the electrodes 
and headband) but current will be provided only for the 30 sec ramp up period and five seconds 
after that, when the current will ramp down. This provides no tDCS-related effect but provides 
the participant with a stimulus that is discernible by most persons. Since many persons only 
perceive the current at the beginning of a stimulation session (even when it continues for 20 
minutes) this is believed to be an adequate control and is a strategy has been used in multiple 
other studies. 
 
As the device does not provide for double-blinding in the delivery of tDCS (i.e., the operator must 
program it and will know if the person receives active or sham stimulation), Dr. Ownby will plan 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 14 
to sit to one side and behind the participant in order to monitor the participant, encourage his 
work on the cognitive training task, provide tutoring on the task and interacting with the computer 
as needed. The study is thus single blind, and we will assess the success of blinding by asking 
participants which group they were in as part of the final study visit. 
 
Cognitive Training. During the study visit, both groups will be asked to work with the n-back 
training program Brain Workshop. The phrase “n-back” refers to the task’s requirement to 
monitor a series of discrete events (either blue blocks flashing on the screen in one of 9 
positions or a series of letter heard over audio) and remember one that occurred a specific 
number prior to the current one. The number of prior events monitored is the “n.” The participant 
is asked to press a letter on a keyboard when the current stimulus matches one delivered “n” 
times previously. For example, for a 2-back task using the letter series “a – d – g – d,” the 
participant would respond with a key press when hearing the second letter “d” as it matches a 
letter presented two instances before the current one.  
 
As this task can be challenging for those with cognitive impairments and we have previous 
experience in using it with older persons, the task’s difficulty is tailored to individuals’ abilities 
and can be increased as the participant shows greater levels of performance over time. 
Participants’ performance is tracked automatically by the software and will be recorded only with 
the participant’s research number. 
 
At the conclusion of this visit and all subsequent visits, participants will provide brief ratings of 
their cognitive function, mood, and level of discomfort (see Appendix for questions). 
 
Randomization: Participants will be randomized to treatment condition in permuted blocks of 
four, with a plan to recruit six blocks of four (total participants 24) based on power analyses that 
suggest a sample size of 12 in each group provides a power of 0.80 to detect between group 
differences. As we wish to obtain a final sample size of 12 in each group, however, depending 
on drop outs or persons otherwise lost to follow-up, we will plan to recruit two additional blocks of 
4 up to a total number of 32 participants. The planned enrollment table in section 2A of this 
protocol thus indicates a possible total enrollment of 32. 
 
5) Subsequent study visits. Participants will complete a total of six 20-minute training sessions 
with sham or true tDCS and working memory training. Participants will be asked to complete 
three sessions per week, and must complete all training sessions within three weeks. 
6) Final study visit. At the final study visit, participants will complete the same brief 
neuropsychological battery done at the screening visit, the depression rating scale (CES-D), the 
Patient’s Own Assessment of Functioning Scale, and be asked to state whether they were in the 
active or sham experimental groups. Final open-ended questions will elicit participants’ 
experience with the study and whether they found it useful (see final visit flow sheet in 
Appendix). 
 
 
Part 4 – Sources of Data Information 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 15 
 
Are you using questionnaires, tests, instruments, or forms?   
 
If “Yes”, list them below and include a copy of each as appendices. 
 
Telephone screening script 
Eligibility visit flow sheet with script and data recording sheet 
Trail Making Test 
Hopkins Verbal Learning Test 
Grooved Pegboard 
Wechsler Adult Intelligence Scale Digit Span recording sheet 
Center for Epidemiological Studies – Depression scale (CES-D) 
Patient’s Own Assessment of Functioning (POAF) 
Participant study visit log (documents date and time of visit) 
Final visit flow sheet 
 
 
Yes  
X 
 
No 
 
 
Do you plan to use any data from records or archives? 
 
If “Yes”, please describe (such as data originally created for non-research purposes or data 
created as a result of a previous study). 
 
HIV RNA viral load and CD4 count from patient’s personal records; potential eligibility for 
participants from a previous study will be evaluated using self-report of cognitive difficulties and 
performance on cognitive measures (“Improving Health Literacy about HIV Infection: Phase I & 
II;” NSU IRB Protocol No. 06120904Exp). 
 
 
Do you plan to use any de-identified data? 
 
If “Yes”, please describe the data and how it will be de-identified. 
 
N/A 
 
 
Yes  
X 
 
No 
 
 
Yes  
 
 
No 
X 
 
 
 
3. Additional Study Information 
3.A.  Clinical Testing  
Food and Drug Administration 
Investigational Drugs and Devices 
Does the study involve the use of an investigational drug?   
 
Yes  
 
 
No 
X 
 
If “Yes”, has an Investigational New Drug application been submitted for the drug? 
 
Yes  
 
 
No 
X 
 
Does the study involve the use of an investigational device?   
 
Yes  
 
 
No 
X 
 
If “Yes”, has an Investigational Device Exemption (IDE) been, or will be, secured prior to the start of 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 16 
the study? 
 
Yes  
 
 
No 
X 
 
Does the study use any device (either as a part of the experiment or to collect data) that has not 
received FDA approved for clinical/medical use or is being used in a manner not consistent with its 
cleared/marketing status? 
 
Yes  
X 
 
No 
 
 
If “Yes”, please describe the device and how its use differs from its approved status by the FDA. 
 
The Chattanooga Ionto electrophoresis device is approved for the delivery of direct current for the 
purpose of enhancing the delivery of drugs transdermally. In this study, the device’s ability to 
deliver a small direct current while having continuous monitoring of impedance and safety will be 
capitalized upon for the purpose of delivering a small current transcranially that may enhance 
participants’ cognitive function. 
 
 
Clinical Procedures 
Does the study involve the use of any procedure that is not used in routine clinical 
practice? 
 
 
Yes  
 
 
No 
X 
 
If “Yes”, please list the procedures. 
 
 
 
 
 
3.B.  Sensitive Information  
Are you asking questions about sensitive issues, such as illegal activity, sexual history, or anything 
else that, if made public, could jeopardize a person’s reputation, employability, safety, 
or quality of life?    
 
Yes  
 
 
No 
X 
 
If “Yes”, please describe the information. 
 
 
 
Does the study involve the collection of data from voice, video, digital, or image 
recordings made for research purposes? 
 
Yes  
 
 
No 
X 
 
If “Yes”, please describe the procedures associated with these recordings. 
 
 
 
 
3.C.  Non-English Speaking Participants 
Will the study involve non-English speaking participants? 
 
Yes  
 
 
No 
X 
 
Will the study require translation of consent forms? 
 
Yes  
 
 
No 
X 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 17 
If you answered “Yes,” please specify the language(s) that the consent forms will be translated in 
to: 
 
 
 
If you are including non-English speaking participants, when you complete section III.H., please 
discuss how you will ensure that the participants understand the study, including the use of a 
qualified translator to provide oral consent information. 
 
3.D.  Subject Compensation 
Will your subjects receive any payments, incentives, or gifts? 
  
Yes  
X 
 
No 
 
 
If “Yes,” please indicate the types of compensation.  Otherwise move on to section E. 
Monetary Payment 
X 
 
Gift 
 
 
Extra credit (Students) or Workplace Incentive (Employees) 
 
 
Other incentive 
 
Please describe: 
 
Participants will receive compensation for each study visit. For the first (eligibility visit) they will 
be provided with $40, while for each of the briefer study visits they will be provided with $20 
cash. They will be compensated $40 for the final study visit. The differences in compensation are 
based on the length of the visits; the first and last visits will require about twice as much time as 
the study training visits. 
 
 
Describe the payment(s)/gift(s)/incentive(s), and if it is a gift, estimate its monetary value.   Indicate 
whether all participants are given the payment/gift/incentive, or if only some are eligible. (Note: the 
value of the payment/gift/incentive should not be so significant that it might compromise the 
subject’s good judgment.) 
 
All participants who complete study procedures will be compensated for their time. In addition to 
the time spent in study activities, many of our participants in previous studies have taken time 
from their schedules or used public transportation to participate. 
 
 
Describe when the subject will receive the payment/gift/incentive, and whether the amount differs 
depending upon whether different portions of the study are completed or is limited if the subject 
discontinues participation during the study.  
 
Participants will be compensated on a pro-rated basis determined by the amount of time 
estimated for each study visit and the planned payment. If a person were to decide to 
discontinue participation after completing one half of the first or final study visit, for example, they 
would be compensated at the rate of ½ of $40, or $20. If they should discontinue other study 
visits they would be compensated in a similar fashion. 
 
 
 
3.E.  Inclusion / Exclusion Criteria for Subjects 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 18 
Describe the inclusion and exclusion criteria for the proposed subjects.  Please list the criteria in 
bullet or outline format rather than narrative.  If the study limits participation based on gender, age 
or race, please justify the exclusion criteria.  (Subject protection and appropriate study design may 
require specific inclusion or exclusion criteria, but the IRB does not permit subject selection that is 
not equitable or prevents a subpopulation from benefiting from the scientific discoveries of the 
study.)   
 
Inclusion Criteria 
 
1) Age 18 years or older 
2) Diagnosed with HIV infection and on antiretroviral therapy for at least one month 
3) Able to meaningfully participate in the informed consent process as determined by clinical 
observation and responses to questions about the study 
4) Right handed 
5) Self-report of cognitive difficulties in at least one of the areas of memory, mental slowing, or 
attention 
6) Score one standard deviation or lower on two of four neuropsychological measures (NB: 
criteria 5 and 6 establish a diagnosis of Mild Neurocognitive Disorder (MND) in combination with 
exclusion criteria below). 
7) Willingness to participate in multiple study visits 
8) Able to provide recent laboratory measures of HIV-RNA (viral load) and CD4 cell counts. 
 
 
Exclusion Criteria 
 
1) Cognitive or psychiatric difficulties so severe as to make the person unable to meaningfully 
participate in the informed consent process as judged during telephone screening and clinical 
interview; 
2) Unclosed skull defect 
3) Metal plate in the skull 
4) Any other metal in the head (e.g., bullet or shrapnel) 
5) History of or current treatment for any seizures 
6) History of adverse reaction to tDCS 
7) Sensitive scalp by self-report, or use of products such as shampoo for sensitive scalp 
8) Recent history (with the past 12 months) of brain injury with loss of consciousness or that 
resulted in any seizure 
9) ) Recent history (with the past 12 months) of neurosurgery involving the brain 
10) Current use of medications that affect dopamine or serotonin reuptake (most commonly, 
antidepressants), dopamine release (e.g., medications for attention deficit/hyperactivity disorder), 
dopamine receptor activity (e.g., antipsychotics, also used as augmenting agents in the treatment 
of depression and as mood stabilizers in bipolar disorder) or GABA function (e.g., 
benzodiazepines, but use of short-acting non-benzodiazepine sleep medications such as 
zolpidem [e.g., Ambien] will be allowed).  
11) Current treatment with any anticonvulsants (carbamazepine (Tegretol), oxcarbazepine 
(Trileptal) lamotrigine (Lamictal), divalproex (Depakote), topiramate (Topamax), levtiracetam 
(Keppra)) or with lithium (lithium or Eskalith). 
12) Current use of bupropion (Wellbutrin SR or XL; Zyban). 
13) History of bipolar disorder or history of mania or hypomania of any type. 
14) Has a pacemaker. 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 19 
 
 
 
3.F.  Subject Recruitment 
How will you recruit subjects (approach/invite/or ask people to be in your study)?   
 
In our previous study (“Improving Health Literacy about HIV Infection: Phase I & II;” NSU IRB 
Protocol No. 06120904Exp), participants provided consent to being recontacted about future 
studies. In this study as well, participants completed a self-report of a questionnaire about HIV-
related problems (including memory and thinking) and a battery of neuropsychological measures. 
Their reports on the questionnaire and their performance on the neuropsychological measures 
will allow us to assess whether they meet Frascati criteria for minor neurocognitive disorder 
(MND) related to HIV infection. Persons meeting these criteria will be contacted about possible 
participation. Preliminary review of data from the previous study show that approximately 50 
persons from this study will be eligible for the new study. We anticipate that many of these 
persons will be interested in participating, but that we may not be able to contact all of these 
persons and all may not be study criteria. Based on our previous work, we anticipate that a 
number of persons will learn of the study by word of mouth and contact us about it. We think it is 
likely that we will be able to complete needed recruitment in this manner. 
 
 
 
Recruitment Advertisements, Fliers, and Letters 
Are you using any letters, fliers, or advertisements?   
 
Yes  
 
 
No 
X 
 
If you answered yes, please list the type(s) below and attach a copy of the proposed materials as 
an appendix (do not copy and paste the flyer into this form). 
(Note: Materials should list “Nova Southeastern University”.) 
 
 
 
 
3.G.  Potential for Coercion in Subject Recruitment 
Are any of the subjects a student or advisee of the PI or a Co-I?   
 
Yes  
 
 
No 
X 
 
Does the PI or a Co-I serve in any capacity (e.g., administrative, therapeutic) that 
might affect a subject’s willingness to participate? 
 
Yes  
 
 
No 
X 
 
If “Yes” to either of the above, then describe the relationship of the subjects and 
investigator. 
 
 
 
If you answered yes, please read the NSU policy about use of students in research.  
http://www.nova.edu/irb/manual/forms/research_students_subjects.pdf  
 
Are any of the subjects employees of, or report to, the PI or a Co-I?  
 
Yes  
 
 
No 
X 
 
Are any of the subjects a patient of the PI or a Co-I?   

 
PI: OWNBY 
Version Date: 12/2/14 
Page 20 
 
Yes  
 
 
No 
X 
 
Are any of the subjects a patient within a PI or a Co-I’s clinical practice? 
 
Yes  
 
 
No 
X 
 
Are any of the subjects informed about the study by their doctor / clinician? 
 
Yes  
 
 
No 
X 
 
 
If you answered “yes” to any of the questions in this section (3.G.), please describe how you will 
ensure that the subjects will feel free to decline participation without fear of reprisal.  If the subjects 
are patients, how will you prevent “therapeutic misconception” (the mistaken belief that when a care 
provider provides information about a study, it means that the provider thinks that study 
participation will benefit the patient). 
 
 
N/A 
 
If you are providing any incentive to the student/employee subjects, discuss whether there is a 
mechanism for students / employees to receive the incentive by doing something other than 
participating in the research project (see 
http://www.nova.edu/irb/manual/forms/research_students_subjects.pdf). 
 
N/A 
 
 
 
 
 
3.H.  Informed Consent 
 
Part 1 – Consent Process 
 
Informed consent is a process that begins with advertising or telling potential subjects about your 
study, continues as the investigator or staff provides details to potential subjects via dialog, and is 
formalized by the signing of the consent.   
 
Note: Minors must have consent of their parents or guardians before you can approach the 
minor about participating in the study.   
Note:  Allow as much time as possible and feasible for the subject to think about whether to 
enroll in the study. Generally, the greater the study risks, the longer the decision period.  
 
Please overview the steps in the consent process in your research study.  If there is more than one 
group of subjects, separately describe the process for each group. 
 
In this study, the informed consent process will begin with initial contact with potential 
participants, most commonly via telephone. We will contact potential participants based on their 
scores on cognitive measures and self-report of cognitive problems during our previous study 
and their previous consent to being recontacted for future studies. During initial contact, 
participants will be informed of the availability of the study and asked whether they are interested 
in becoming a participant. If they indicate that they are interested, the phone interviewer will 
provide details of the study such as the inclusion and exclusion criteria, the nature of the 
intervention, time required to complete the study (time and number of study visits), need to 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 21 
provide results of HIV viral load and CD4 cell count, potential risks, and compensation. If the 
potential participant continues to indicate an interest in participating, their verbal assent to ask 
questions about their thinking and memory will be asked (see telephone script in appendix). If 
the potential participant gives verbal permission, their response will be recorded and then the 
three screening questions (see script) will be asked. If the potential participants responds no to 
all questions, they will be thanked for their willingness to talk and their time, and informed that 
they are not eligible for the study. They will be asked if they have any questions and if so they 
will be answered. If not, they will be thanked and the interview will be ended. 
 
If the participant answers yes to any of the questions (indicating that they experience symptoms 
of cognitive dysfunction), they will be informed that they may be eligible for the study and that 
the interviewer would like to ask more questions about their medical history and treatment. The 
interviewer will request verbal assent for these questions as well. He or she will then review 
study exclusion criteria (see questions and checklist in the telephone screening script). If the 
person continues to be eligible, the interviewer will inform the potential participant of this fact and 
state that final eligibility determination depends on additional in-person evaluation. They will be 
informed that the in-person screening will involve the administration of a 30-45-minute battery of 
neuropsychological measures of memory, attention, and executive function and questions about 
their mood and mental functioning. They will be informed that they will be paid $40 for the visit 
even if they do not qualify for the study (and that their compensation will be pro-rated if they 
choose to leave before the completion of the visit) and that they will be informed of their eligibility 
during the visit. 
 
The informed consent process will continue at the eligibility visit. Scheduled participants will 
again be reminded of the nature of the research study and the requirements of the study. If they 
continue to indicate an interest in participating, their verbal permission to complete the brief 
battery of neuropsychological measures will be solicited, after the measures and time required is 
again stated. Their response will be recorded, and if they assent to the assessment, the brief 
battery of measures will be administered. After administration, the potential participant will be 
offered a break with refreshments (coffee, tea, soda, snacks) while the researcher scores the 
measures to assess the potential participant’s eligibility. If the potential participant does not 
score in the range to make them eligible for the study, they will be informed of this fact, thanked, 
for their interest and participation, and provided compensation. 
 
If the participant scores at levels that make them eligible for the study, they will be informed of 
this and asked if they continue to be interested in participating. If they continue to indicate an 
interest in participating, they will be asked if they are available to complete additional informed 
consent procedures, including review of the written informed consent form. If they indicate that 
they are available for this additional activity, the informed consent form will be given to the 
participant and encouraged to read it. The researcher will review the form with the potential 
participant as well, and the potential participant will be asked if she or he has any questions 
about the study. The potential participant will then be asked the three questions developed by 
Palmer et al. and validated against the longer MacArthur Assessment of Competence—Clinical 
Research (Palmer et al., 2005). If the potential participant does not achieve an adequate score 
on the three questions (each can be scored as 0, 1 or 2 based on the person’s demonstrated 
understanding of the study’s purpose, risks, and benefits for a total of 6) the person obtaining 
written informed consent will review the relevant information and again ask the person to explain 
the issue in which he or she did not demonstrate adequate understanding. The potential 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 22 
participant’s final score must be 4 of 6 to be eligible for the study as this indicates a clear 
understanding of at least one area and at least partial understanding of several others. In the 
Palmer et al study, this score had a high degree of sensitivity in detecting those with inadequate 
understanding of clinical research on a longer measure. 
 
After this discussion, the participant will be asked if he or she is ready to sign the form; if so, they 
will sign the form, but if not, they will be encouraged to review the form and the investigator will 
answer any questions. If the participant declines to sign the form, the study visit will be 
concluded and the potential participant will be compensated for their time in the eligibility portion 
in the study. 
 
After providing written informed consent, participants will be asked to complete several 
questionnaires (the depression questionnaire (CES-D) and the Patient’s Own Assessment of 
Functioning as well as ratings of cognitive functioning and mood). The visit will conclude with 
scheduling the first study visit and providing the participant with compensation. 
 
The informed consent process will continue during the active or sham treatment sessions during 
which the participant’s reactions and concerns about the study procedures will be actively 
elicited by the investigator. During each study session, the participant will be asked if she or he 
has any questions or concerns about the previous session; these will be recorded and 
responded to. Participants will be reminded that their participation is completely voluntary and 
that they can discontinue the study at any time without loss of any benefits to which they might 
be entitled. 
 
 
 
 
 
 
 
Part 2 – Consent Process and Document Waiver/Alteration Information 
In most cases, subjects need to participate in a meaningful consent process and receive a 
consent/assent form that documents agreement to participate in research.  However, in a few cases 
the subject’s confidentiality is protected by waiving/altering consent procedures or the requirement 
for signed consent forms.  Please read the IRB’s policy on informed consent for explanations, 
including what the IRB must demonstrate to permit waiver or alteration 
(http://www.nova.edu/irb/manual/forms/informed_consent.pdf).  Please note, however, that while 
your study may qualify for waiver or alteration, that determination is at the discretion of the IRB. 
 
One case where a signed informed consent form is NOT used is when a researcher is only 
reviewing existing/archival data that were collected for non-research purposes.  If the data are 
obtained from the records by someone with authorization, and the data are de-identified, then it may 
be appropriate not to ask subjects (those whose data you are collecting) to provide consent, 
because the research involves no more than minimal risk, the waiver or alteration will not adversely 
affect the rights or welfare of subjects, the research could not practicably be carried out without the 
waiver or alteration, and, when appropriate, the subject will be provided pertinent information about 
participation.  (NOTE: If your study has other procedures that require interaction with subjects or 
prospective collection of data, it is unlikely that waiver or alteration of consent procedures or the 
signing of consent forms would be appropriate.)  If this describes your study, then you may request 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 23 
a waiver of the requirement for informed consent and the documentation of signed consent. 
 
If you think this applies in your study, please describe your rationale. 
 
 
 
Another situation involving waiver or alteration of the requirement to obtain a signed consent form is 
when the research only entails conducting anonymous surveys that are not intrusive.  If there is no 
way that the subjects’ responses could be linked to them, then waiving the requirement for a signed 
consent form would minimize a risk to their confidentiality and privacy because the only record 
linking the subject and the research would be the consent form.  If the principal risk would be 
potential harm resulting from a breach of confidentiality and the research presents no more than 
minimal risk to subjects and involves no procedures for which written consent is normally required 
outside of the research context, then the elements of informed consent are put into the survey itself.  
The person indicates his/her voluntary participation by completing the survey after being advised 
about the study and voluntary nature of his/her participation. 
 
If you think this applies in your study, please describe your rationale. 
 
 
 
There may be other cases where you would wish to ask for a waiver or alteration of informed 
consent or signed consent documentation.   
 
If you are seeking a waiver or alteration, please describe your rationale. 
 
 
 
Part 3 – Consent and Assent Document Information 
Typically, you are asked to use the NSU format consent and assent forms.  However, if this is 
cooperative research, or sponsored research that requires the use of a different template or model, 
you may use their format.   
I will use NSU format consent/assent forms  
 X 
I will be using another institution’s format for consent/assent forms (NOTE: Please review the 
other institution’s consent forms and the NSU requirements to be sure that all of the NSU 
requirements are present.  You may also want to discuss the consent forms with your 
college/center representative) 
 
 
As noted above, I am requesting a waiver/alteration of consent and/or signed consent form 
requirements 
 
 
If you have different procedures for different groups of subjects, you will need a separate consent 
and/or assent form for each group.  If the reading level of different groups of subjects differs, this 
may also require you to have different consent and/or assent forms (e.g. young children vs. 
adolescents).  If your subjects are children, you will also need parental consent. 
 
What is the total number of consent/assent form types that you plan to use? 
1 
 
If using more than one consent form, create a list below that describes the different forms that you 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 24 
will be using (e.g. 1. Teacher consent form, 2. Parent consent form, 3. Assent form for children age 
7-12, 4. Assent form for adolescents). 
 
 
Include copies of the consent / assent forms.  When you attach the consent forms, put them in this 
order.  Please note that the IRB prefers that the consent document be written using the simplest 
language possible, and strongly recommends the question and answer format (see Document 
Model #1 for Adult/General Consent Form [Readability Score: Grade 6]).  
 
3.I.  Protected Health Information Use 
Are you obtaining any data from the subject’s medical record? 
 
Yes  
 
 
No 
X 
 
Are you asking the subject about his or her health information, and doing so in a clinic or entity that 
would normally be subject to HIPAA regulations on protected health information?   
 
Yes  
 
 
No 
X 
 
If you answered “Yes” to either question, continue.  Otherwise go on to section 3.J. 
Please review the NSU HIPAA research policies available at 
(http://www.nova.edu/irb/manual/policies.html  for more information.   
 
Please note that effective 12/10/2009 the NSU IRB no longer reviews separate HIPAA 
authorizations for research.  It is the principal investigator’s responsibility to use the correct HIPAA 
authorization as outlined in the aforementioned policy.  In instances where the HIPAA authorization 
must be a part of the informed consent form for research, the NSU IRB will review the compound 
consent. 
Specify the exact data to be gathered (e.g., weight, blood pressure, IQ score, diagnosis, depression 
rating, number of treatments, etc.).  
 
Participants will be required to provide recent (within 3 months) results of HIV RNA (viral load) 
and CD4 counts as part of initial assessment for participation in the study. 
 
 
Which procedure are you proposing to use? (Check) 
I will obtain the subject’s authorization to obtain the protected health information via the NSU 
Authorization for Use and Disclosure of Protected Health Information in Research (research 
activities will be occurring at an NSU clinic).  
 
 
I will obtain the subject’s authorization to obtain the protected health information via the 
authorization for use and disclosure of protected health information in research provided by 
the non-NSU covered entity. 
 
 
The protected health information data are a fully de-identified data set (data obtained without 
recording any patient information, with the data accessed by an employee of the institution). 
 
 
The data are part of a limited data set agreement as defined by the Office of Human 
Research Protections.  (Attach a copy of the agreement.)  
 
 
If part of a limited data set agreement, what is the justification that confidentiality is protected? 
 
 
 
I have a waiver provided by a duly constituted privacy board. (Attach a copy of the waiver.) 
  
HIPAA Research Authorization 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 25 
If the research is to be conducted at an NSU clinic, have you created a HIPAA authorization form 
as outlined in the HIPAA Research Policy No. 1 (http://www.nova.edu/irb/manual/policies.html) and 
in keeping with the Instructions for Preparing the Authorization For Use and Disclosure of Protected 
Health Information in Research Form and the model form provided 
(http://www.nova.edu/irb/manual/forms.html)?  
 
Please note, do NOT submit a copy of the HIPAA authorization form if you are following the model 
noted in the aforementioned policy. 
Yes  
 
 
No 
X 
 
If the research is to be conducted at a non-NSU covered entity, have you reviewed the HIPAA 
Research Policy No. 6: Guidance on Research at Outside Entities 
(http://www.nova.edu/irb/manual/policies.html)?   
 
 
Researchers are advised to discuss the proposed research with the applicable HIPAA privacy 
officer at the non-NSU covered entity. 
Yes  
X 
 
No 
 
 
Does the researcher sponsor or cooperating agency require the incorporation of the HIPAA 
authorization within the consent document (Compound Consent)? 
 
 
If yes, please briefly indicate who requires that this be in the informed consent document. 
 
 
 
Please note, consent forms that include the HIPAA authorization may need approval from the 
university Office of Corporate Compliance. 
Yes  
 
 
No 
X 
 
 
3.J.  Student/Academic Information Use 
Are you obtaining any data from the subject’s academic records? 
 
Yes  
 
 
No 
X 
 
If you answered “Yes”, continue.  Otherwise go on to section K. 
Specify the exact data to be gathered (e.g., GPA, standardized test score, IQ score, 
medical/psychological information stored in academic files, attendance records, disciplinary 
records, etc.).  
 
 
 
Specify how you will obtain the data. 
 
 
 
Which procedure are you proposing to use? (Check all that apply) 
I will obtain the subject’s consent to obtain the academic information. 
 
 
The academic information will be a part of a fully de-identified data set (data obtained without 
recording any subject information, and provided to you in keeping with the institution’s policies and 
the Federal Educational Rights and Privacy Act [FERPA]). 
 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 26 
 
3.K.  Risks, Discomforts, & Inconveniences  
In this section, discuss all potential risks (physical, economic/financial, legal, psychological, social, 
etc.), discomforts, or inconveniences to the subjects.   
 
All studies using identifiable subject information must address the issue of possible loss of 
subject confidentiality 
 
Some possible risks include physical, psychological or emotional harm, breach of 
confidentiality, and invasion of privacy.  
 
Discomfort includes anticipated risk for mild physical or emotional pain.   
 
Study inconveniences include loss of time or pay.   
 
Each risk, discomfort and inconvenience should be addressed individually in the following format 
(use the tables provided and copy if the study presents more than 3).   
 
List each risk individually 
 
Discuss likelihood:  How likely is it that this risk/discomfort or inconvenience will occur?  This 
is usually classified as minimal, moderate, or high. 
 
Discuss magnitude/duration:  How dire is the risk/inconvenience/discomfort, and if it occurs, 
how long do you expect that the subject will be affected? 
 
Discuss risk minimization: Describe the procedures undertaken to minimize the risk that this 
specific risk/discomfort/inconvenience will occur. 
 
Risk/Discomfort  
Discomfort, tingling, itching, or redness at tDCS electrode sites 
Likelihood 
High (greater than 20% based on data from Poreisz et al., 2007) 
Magnitude/Duration 
Mild/throughout the study 
Risk Minimization 
Participants will be closely monitored during treatment sessions. If 
impedance changes during treatment, the tDCS device will automatically 
stop current delivery. Participants will be encouraged to report any 
discomfort, and should the discomfort increase substantially the tDCS 
delivery will be stopped. If the person experiences vesicles or evidence 
of skin irritation that does not resolve promptly (i.e., within 20 minutes) 
after discontinuation of the tDCS, he or she will be dropped from the 
study. 
 
Risk/Discomfort  
Burn at electrode site 
Likelihood 
Very low (less than 1%) 
Magnitude/Duration 
Moderate/throughout the study 
Risk Minimization 
Participants will be closely monitored during treatment sessions. If 
impedance changes during treatment, the tDCS device will automatically 
stop current delivery. Dr. Ownby or Ms. Davenport will be in the office at 
all times during study visits, and will be able to monitor the participant. 
Participants will be encouraged to report any discomfort, and should the 
discomfort increase substantially the tDCS delivery will be stopped. A 
recent FDA advisory panel reviewed adverse effect data from studies 
using electrophoresis devices and concluded that risks of burns are low 
(see discussion of safety, above). 
 
Risk/Discomfort 
Fatigue 
Likelihood 
High (35% based on data from Poreisz et al., 2007) 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 27 
Magnitude/Duration 
Moderate/throughout the study 
Risk Minimization 
Participants will be closely monitored during all study visits; each visits 
will begin with a review of any problems that occur between visits and 
each will end with a review of discomfort and an open-ended discussion 
of any problems of concerns so that participants can readily 
communicate any issue they experience. 
 
Risk/Discomfort 
Difficulties in concentrating 
Likelihood 
Moderate (4-10% based on data from Poreisz et al., 2007) 
Magnitude/Duration 
Moderate/throughout the study 
Risk Minimization 
Participants will be closely monitored during all study visits; each visits 
will begin with a review of any problems that occur between visits and 
each will end with a review of discomfort and an open-ended discussion 
of any problems of concerns so that participants can readily 
communicate any issue they experience. 
 
Risk/Discomfort 
Manic or hypomanic episode 
Likelihood 
Low 
Magnitude/Duration 
Moderate/throughout the study 
Risk Minimization 
Several participants in previous studies of tDCS for depression 
developed manic or hypomanic episodes. In the largest and best 
controlled study (Brunoni et al., 2013), the occurrence of these episodes 
was similar in groups receiving only antidepressant medication and in 
those receiving antidepressant medication plus tDCS. Since some 
persons who appear to have unipolar depression may actually have 
unrecognized bipolar disorder, the significance of this finding for risk in 
studies of tDCS for cognitive problems is not clear. In order to minimize 
this risk, however, we will screen persons for a history of mania or 
hypomania as well as for a personal or family history of bipolar disorder. 
We will also exclude anyone taking mood stabilizing medication 
(anticonvulsants or lithium; see list in exclusion criteria) as patients are 
sometimes given mood stabilizers for possible mood disorders without a 
clear understanding of the purpose of these medications. 
 
Risk/Discomfort 
Distress, frustration, or fatigue from the difficulty of the computer-
delivered cognitive training task 
Likelihood 
Low 
Magnitude/Duration 
Mild/throughout the study 
Risk Minimization 
Participants will be closely monitored during training sessions and 
provided ongoing coaching and encouragement to help them become 
proficient at the memory and attention task and to not become 
excessively frustrated. The task itself is designed to begin with a low 
level of difficulty and progress so as to continuously challenge the 
participant without becoming excessively difficult. We have already 
completed preliminary acceptability testing of the cognitive training 
activity with a group of HIV+ participants who are similar to those to be 
enrolled in the proposed study (“Usability of Revised Educational and 
Cognitive Training Interventions for HIV,” Protocol No. 05251228Exp) 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 28 
and found a high level of acceptance for it. 
 
Risk/Discomfort 
Inadvertent disclosure of HIV status or other information that might be 
embarrassing to the participant. 
Likelihood 
Low. 
Magnitude/Duration 
Large/throughout the study 
Risk Minimization 
All data recording will either be done on coded paper sheets or in 
electronic format with the participant only identified by a number. The 
record of the relation of participant number to participant identifying 
information will be kept separate from study files in a locked file cabinet 
in an office that is also locked outside of normal business hours. The 
office is in the researchers’ suite of offices, which are themselves locked 
at all times. 
 
Risk/Discomfort 
Upset from discussions of cognitive difficulties or review of mood 
symptoms 
Likelihood 
Low 
Magnitude/Duration 
Potentially serious/throughout the study 
Risk Minimization 
Based on our previous experience, many participants are already aware 
that HIV infection may result in cognitive or mood symptoms. Discussion 
and assessment activities (e.g., completing a depression rating scale) 
can increase this awareness and may result in upset. The researchers 
are acutely aware of this possibility and will monitor participants’ reaction 
to screening questions, determination of eligibility, and study 
participation. Only one participant (of a total of 124) in our previous study 
became upset when learning about the implications of HIV infection. 
When this occurred, it was possible for Dr. Ownby to meet with the 
participant, debrief him or her, and determine the need for additional 
counseling or treatment. In this study we will debrief participants after 
each study visit with respect to their reactions to the study measures and 
procedures. They will be provided with brief counseling when needed 
and will be referred to community resources if further treatment is 
required. 
 
 
One way in which confidentiality is partially protected is to destroy study documents containing 
identifiable information when they are no longer needed. The IRB requires that study materials be 
kept for a minimum of three years from the end of the study to permit study auditing; you may elect 
to keep them for a longer period of time and study sponsors may have their own data retention 
requirements.  Please indicate when and how you plan to destroy data that contains identifiable 
subject information, such as consent forms, lists that link subject identity to data coding, or raw data 
containing subject names. 
 
Data will be retained for a minimum of three years after the conclusion of the study. Paper 
records will be destroyed through secure document destruction services, while electronic data 
will be destroyed by overwriting relevant portions of computer hard drives with software that 
overwrites memory areas with irrelevant data on multiple occasions. 
 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 29 
 
3.L.  Benefits to Subjects 
In this section, discuss all direct benefits of the study to participants. This does not include “helping 
research” or other generalities, nor does it include compensation for participation.  Some examples 
of benefits include receiving free treatment, receiving a list of reputable local services, or obtaining 
tutoring. The value of any such benefits should be listed as well. If there are no direct benefits to the 
participants, this should be indicated.  
 
Are there any direct benefits to the research participants? 
There are no direct benefits to study participants 
X 
 
This study provides benefit to, or is likely to benefit, the participants 
 
 
List/describe each benefit 
 
 
 
 
 
3.M.  Data Analysis Plan 
Please describe preliminarily proposed data analysis procedures. 
 
Study outcomes will be evaluated through analysis of group differences on neuropsychological 
measures after correction for baseline differences in age, disease status (CD4 count), mood, 
and baseline performance. Additional outcomes will include the rate of learning in the computer-
delivered memory and attention task between groups. Individual and group slopes for the task 
will be plotted and visually inspected as well as tested using parametric statistics.  
 
 
 
3.N.  Scientific Benefit 
Briefly discuss how generalization of the information obtained from this study will be scientifically 
useful, or useful to your research site. 
 
The demonstration that tDCS has a positive impact on cognitive training in persons with HIV-
related MND would have significant implications for the development of strategies to enhance 
cognitive functions in persons with MND. As these cognitive functions have been related to 
functional status and medication adherence in persons with HIV, improving cognition have 
important effects on clinical outcomes and, since adherence is related to viral suppression which 
is in turn related to infectivity, the study may have important implications for public health.  
 
Results of this study may demonstrate the feasibility of tDCS studies at NSU and provide 
preliminary data that will be used in applications for additional NIH funding. 
 
 
 
 
3.O.  Risk/Benefit Ratio 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 30 
To be approved, a study needs to have greater benefits than risks. Why do you believe this study 
has a positive benefits-to-risks ratio? 
 
The benefits of the study are the demonstration of a potentially useful strategy for improving 
cognitive function in persons with HIV-related cognitive function. Previous studies of computer-
based cognitive training have shown that it can be accomplished with very little likelihood of 
adverse events. Similarly, multiple studies of tDCS have shown that it can be used to enhance 
cognition and mood in healthy individuals and those with a variety of neurocognitive and pain 
disorders. These studies as well as a recent review of the safety of iontophoresis devices for an 
FDA advisory panel show that these devices for delivery small electrical currents are safe. The 
potential benefits of the knowledge to be achieved are thus substantial while the potential risks 
are very small, resulting in a positive benefits to risk ratio. 
 
 
 
3.P.  Safety Monitoring Plans 
All researchers are required to report adverse events and unanticipated problems in keeping with 
the NSU IRB policy (http://www.nova.edu/irb/manual/forms/adverse_events.pdf ). 
 
Studies that entail significant risk to subjects, such as randomized controlled drug 
trials, may warrant safety monitoring by an outside safety board.  Does your study 
utilize a Data Safety Monitoring plan?    
 
If “Yes,” please describe the safety monitoring plans.  Please specify if the study will be monitored 
by the investigators, sponsors (if applicable), or a Data Safety Monitoring Board (DSMB).  
Sponsored studies may reference an attached Investigator Brochure. 
 
For this study, we do not intend to empanel as DSMB but will provide close and ongoing 
monitoring of each participant during study procedures. An investigator will be present at all times 
during study sessions including those that involve sham tDCS, and all participants will be 
debriefed at the conclusion of each study session. This verbal debriefing will include questions 
about discomfort, fatigue, and frustration. Participants will also complete brief ratings of mood, 
mental functioning, and discomfort (see appendix) at the end of each session to allow additional 
monitoring of participant reactions to the study. 
 
 
Yes  
X 
 
No 
 
 
 
3.Q.  Other Information 
If there is other information about this study that is required in order for those reviewing the study to 
fully understand the study, its risks and benefits, please describe below. 
 
 
 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 31 
 
3.R.  Principal Investigator Assurance and Obligations 
I certify that all information provided in this submission (including any supporting documents) is a complete 
and accurate description of the proposed study. I agree to the following: 
This study will be conducted in the manner described 
in this submission and will not be implemented 
(including subject recruitment or consenting) until all 
applicable IRBs have granted permission to conduct 
the research.  No changes to this study will be 
implemented until an amendment form has been 
submitted and approved by the IRB.  
 
 
If the IRB approves this study via expedited or full 
procedure, I will submit for continuing review as 
stipulated in the approval letter. If the study or data 
analysis will exceed the approval period, I will submit 
a Submission Form for Continuing Review of IRB 
Approved Studies in a timely manner (well in 
advance of the renewal date).  I understand that 
study activities may not continue past an approval 
period. 
 
I will provide a copy of the signed 
consent form to the subject or 
patient, if applicable.  
 
 
PI Initials 
 
PI Initials 
 
PI Initials 
 
I will retain all signed informed consent documents 
and study-related records for a minimum of three (3) 
years (or longer as stipulated by funding agencies) 
from the date the study is concluded.  
 
 
I will report in writing any serious adverse events to 
the IRB within 24 hours and all other adverse events 
and unanticipated problems within 5 working days. 
 
 
I will provide participants with any significant new 
information obtained during the course of the study 
and submit reports of new information to the IRB as 
a Study Amendment.  
 
 
If my study has been approved at the Expedited or 
Full Review levels, I will report to the IRB when this 
study has closed (no further data collection or 
analysis). This report will be provided no later than 
30 days after the end of the study 
via the IRB Closing Report Form. 
PI Initials 
 
PI Initials 
 
PI Initials 
 
PI Initials 
 
 
Principal Investigator’s Signature: _______________________________Date: _____________ 
 
3.S.  Co-Investigator Assurance and Obligations (for Student PIs) 
If this study is for the completion of a degree requirement, the thesis adviser or dissertation chair 
must sign the attestation below. 
 
 
All departmental approvals by the student’s committee (if applicable) and chair or thesis adviser have 
been completed. 
 
I accept that the University and IRB consider the faculty advisor’s responsibility to be equal to that of 
the student in regard to  
o The quality of the research design AND the accuracy of the protocol 
o The appropriateness of the recruitment methods, the design of the process for informing the 
subjects about the nature of the study, and the process of obtaining informed consent 
o The readability, accuracy, and format of the informed consent/assent document(s) and the 
explanation of all informed consent procedures.  
 
My signature below attests that I have read this submission in its entirety and believe that it is 
accurate, complete, appropriate, and adheres to the principles of the Belmont report and that all 
departmental approvals by the student’s committee have been completed. 
 
Chair/Adviser’s Signature: ____________________________________Date: _____________ 
 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 32 
 
Reference List 
 
Ackerman, M., Vance, D., Fazeli, P., & Ross, L. (2010). The effect of a speed of processing 
intervention on adults with HIV [abstract]. Archives of Clinical Neuropsychology, 25, 
475-583. 
Antinori, A., Arendt, G., Becker, J. T., Brew, B. J., Byrd, D. A., Cherner, M. et al. (2007). 
Updated research nosology for HIV-associated neurocognitive disorders. Neurology, 69, 
1789-1799. 
Ball, K., Edwards, J. D., & Ross, L. A. (2007). The impact of speed of processing training on 
cognitive and everyday functions. J.Gerontol.B.Psychol.Sci.Soc.Sci., 62 Spec No 1, 19-
31. 
Bikson, M., Datta, A., & Elwassif, M. (2009). Establishing safety limits for transcranial direct 
current stimulation. Clin.Neurophysiol., 120, 1033-1034. 
Bikson, M., Inoue, M., Akiyama, H., Deans, J. K., Fox, J. E., Miyakawa, H. et al. (2004). Effects 
of uniform extracellular DC electric fields on excitability in rat hippocampal slices in 
vitro. J.Physiol, 557, 175-190. 
Bikson, M., Rahman, A., & Datta, A. (2012). Computational models of transcranial direct 
current stimulation. Clin.EEG.Neurosci., 43, 176-183. 
Boggio, P. S., Ferrucci, R., Rigonatti, S. P., Covre, P., Nitsche, M., Pascual-Leone, A. et al. 
(2006). Effects of transcranial direct current stimulation on working memory in patients 
with Parkinson's disease. J.Neurol.Sci., 249, 31-38. 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 33 
Brunoni, A. R., Valiengo, L., Baccaro, A., Zanao, T. A., de Oliveira, J. F., Goulart, A. et al. 
(2013). The sertraline vs. electrical current therapy for treating depression clinical study: 
results from a factorial, randomized, controlled trial. JAMA Psychiatry, 70, 383-391. 
Cicerone, K., Levin, H., Malec, J., Stuss, D., & Whyte, J. (2006). Cognitive rehabilitation 
interventions for executive function: Moving from bench to bedside in patients with 
traumatic brain injury. Journal of Cognitive Neuroscience, 18, 1212-1222. 
Clark, V. P., Coffman, B. A., Mayer, A. R., Weisend, M. P., Lane, T. D., Calhoun, V. D. et al. 
(2012). TDCS guided using fMRI significantly accelerates learning to identify concealed 
objects. Neuroimage., 59, 117-128. 
Coffman, B. A., Trumbo, M. C., Flores, R. A., Garcia, C. M., van der Merwe, A. J., 
Wassermann, E. M. et al. (2012). Impact of tDCS on performance and learning of target 
detection: interaction with stimulus characteristics and experimental design. 
Neuropsychologia, 50, 1594-1602. 
Fregni, F., Boggio, P. S., Nitsche, M., Bermpohl, F., Antal, A., Feredoes, E. et al. (2005). Anodal 
transcranial direct current stimulation of prefrontal cortex enhances working memory. 
Exp.Brain Res., 166, 23-30. 
Fritsch, B., Reis, J., Martinowich, K., Schambra, H. M., Ji, Y., Cohen, L. G. et al. (2010). Direct 
current stimulation promotes BDNF-dependent synaptic plasticity: potential implications 
for motor learning. Neuron, 66, 198-204. 
Heaton, R. K., Clifford, D. B., Franklin, D. R., Jr., Woods, S. P., Ake, C., Vaida, F. et al. (2010). 
HIV-associated neurocognitive disorders persist in the era of potent antiretroviral 
therapy: CHARTER Study. Neurology., 75, 2087-2096. 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 34 
Heaton, R. K., Franklin, D. R., Ellis, R. J., McCutchan, J. A., Letendre, S. L., Leblanc, S. et al. 
(2011). HIV-associated neurocognitive disorders before and during the era of 
combination antiretroviral therapy: differences in rates, nature, and predictors. J 
Neurovirol., 17, 3-16. 
Jaeggi, S. M., Buschkuehl, M., Jonides, J., & Shah, P. (2011). Short- and long-term benefits of 
cognitive training. Proc.Natl.Acad.Sci.U.S.A, 108, 10081-10086. 
Kuo, M. F., Paulus, W., & Nitsche, M. A. (2008). Boosting focally-induced brain plasticity by 
dopamine. Cereb.Cortex, 18, 648-651. 
Liebetanz, D., Koch, R., Mayenfels, S., Konig, F., Paulus, W., & Nitsche, M. A. (2009). Safety 
limits of cathodal transcranial direct current stimulation in rats. Clin.Neurophysiol., 120, 
1161-1167. 
Loewenstein, D. A., Acevedo, A., Czaja, S. J., & Duara, R. (2004). Cognitive rehabilitation of 
mildly impaired Alzheimer disease patients on cholinesterase inhibitors. 
Am.J.Geriatr.Psychiatry., 12, 395-402. 
Loo, C. K. & Martin, D. M. (2012). Could transcranial direct current stimulation have 
unexpected additional benefits in the treatment of depressed patients? 
Expert.Rev.Neurother., 12, 751-753. 
Martin, D. M., Liu, R., Alonzo, A., Green, M., Player, M. J., Sachdev, P. et al. (2013). Can 
transcranial direct current stimulation enhance outcomes from cognitive training? A 
randomized controlled trial in healthy participants. Int.J.Neuropsychopharmacol., 16, 
1927-1936. 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 35 
Nitsche, M. A., Fricke, K., Henschke, U., Schlitterlau, A., Liebetanz, D., Lang, N. et al. (2003). 
Pharmacological modulation of cortical excitability shifts induced by transcranial direct 
current stimulation in humans. J.Physiol, 553, 293-301. 
Ohn, S. H., Park, C. I., Yoo, W. K., Ko, M. H., Choi, K. P., Kim, G. M. et al. (2008). Time-
dependent effect of transcranial direct current stimulation on the enhancement of working 
memory. Neuroreport, 19, 43-47. 
Palmer, B. W., Dunn, L. B., Appelbaum, P. S., Mudaliar, S., Thal, L., Henry, R. et al. (2005). 
Assessment of capacity to consent to research among older persons with schizophrenia, 
Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a 
comprehensive standardized capacity instrument. Arch.Gen.Psychiatry, 62, 726-733. 
Poreisz, C., Boros, K., Antal, A., & Paulus, W. (2007). Safety aspects of transcranial direct 
current stimulation concerning healthy subjects and patients. Brain Res.Bull., 72, 208-
214. 
Rahman, A., Reato, D., Arlotti, M., Gasca, F., Datta, A., Parra, L. C. et al. (2013). Cellular 
effects of acute direct current stimulation: somatic and synaptic terminal effects. 
J.Physiol, 591, 2563-2578. 
Rourke, S. (2011). HIV-related cognitive decline [Online] Accessed 4/25/12 at 
http://www.positscience.com/human-brain/clinical-conditions/hiv-related-cognitive-
decline. 
Vance, D. (2010). Improving speed of processing and everyday functioning in adults with HIV 
by using cognitive remediation therapy [Abstract]. European Journal of Neurology, 
17(suppl 3), 568. 

 
PI: OWNBY 
Version Date: 12/2/14 
Page 36 
Willis, S. L., Tennstedt, S. L., Marsiske, M., Ball, K., Elias, J., Koepke, K. M. et al. (2006). 
Long-term effects of cognitive training on everyday functional outcomes in older adults. 
JAMA., 296, 2805-2814.