Working Memory Training Combined With Transcranial Magnetic Stimulation in Smokers: 2x2 Factorial Study
Phase: PHASE2
Conditions: Tobacco Use Disorder
Sponsor: Kent State University

Working Memory Training combined with Transcranial Magnetic Stimulation in Smokers. 
NCT03337113 
Document date 4/4/2018 

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IRB # 1705-003/IRBNet# 1054787 
BUTLER HOSPITAL 
INSTITUTIONAL REVIEW BOARD 
PROTOCOL 
ATTENTION: 
 Before completing this protocol, go to the Butler IRB Forms library on IRBNet and 
 Download the most recent version.  Consult the IRB Guidelines for updated directions. 
1.) TITLE OF PROJECT: Working Memory Training combined with Transcranial Magnetic Stimulation 
in Smokers: 2x2 Factorial Study 
Principal Investigator (PI):  William Lechner, PhD 
 
 
 
 
 
 
 
 
 
Other Investigator(s):   
Noah Philip, MD; Linda Carpenter, MD  
   
                              
2.)Description of Study 
A. Specific Aims   
The primary objective of the proposed study is to evaluate the potential for improved effects and examine 
mediating pathways of Working Memory Training (WMT) in combination with Repetitive Transcranial 
Magnetic Stimulation (rTMS) on a laboratory based smoking task and neuropsychological measures of 
Working Memory (WM) performance. These aims will be examined in a sample of tobacco dependent 
adults (N=130) utilizing a 2x2 factorial design including four groups (WMT+rTMS, sham WMT+rTMS, 
WMT+sham TMS, and sham WMT+sham rTMS) capable of isolating independent and combined effects of 
WMT and rTMS. The study will include a baseline assessments of neurocognitive, psychological, and 
smoking related variables, 10 WMT sessions over two weeks, followed by 10 days of WMT immediately 
preceding and following brain stimulation sessions (10 Hz rTMS, 2000 pulses per session, applied to left 
DLPFC). Neurocognitive and psychological mediators will be assessed between baseline and final 
laboratory assessment. Lastly, a follow-up assessment will occur one-month after the final laboratory 
visit. The proposed study will test the following Specific Aims: 
 
Aim 1: To test the potential for improved effects of combining WMT with rTMS on smoking 
behaviors as compared to the independent effects of either condition alone. Hypothesis: Single 
active conditions (WMT+sham rTMS and sham WMT+rTMS) will result in significantly greater time to 
lapse on a smoking  analogue task1 (a lab based task that measures an individual’s ability to resist 
smoking) as compared to the double sham condition (sham WMT+sham rTMS), and the WMT+rTMS 
condition will result in significantly greater time to lapse as compared to the single active conditions.   
 
Aim 2: To test the potential for improved effects of combining WMT with rTMS on WM 
performance. Hypothesis: WMT + rTMS will result in significant increases in WM performance as 
compared to all other conditions, including the additive increases in conditions outlined in Aim 1.  
 
Aim 3: To test mediating pathways of the effects of rTMS on smoking behaviors including changes 
in craving, mood, and WM performance. Hypothesis: The direct effect of rTMS on smoking outcomes 
will be mediated by gains in WM performance, and this effect will be largest in the WMT+rTMS condition. 
 
B. Background  
Smoking remains the leading cause of preventable death in the U.S.2. Current first line treatments leave 
approximately 70% of tobacco dependent individuals unsuccessful in their attempt to quit3, 4. Specifically, 
only 5-30% of those who initiate treatment, including intensive first-line interventions, are able to 
maintain abstinence for one or more years4, 5. The inability to quit despite motivation to do so is thought 
to result, in part, from self-control failure and can be understood within the framework of dual process 
models of addiction6. Dual process models view vulnerability to tobacco dependence as the relative 
balance between automatic impulses and control processes orchestrated through the interplay of 

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multiple executive functions7, 8. Working memory (WM) is an executive function associated with updating 
information to solve immediate problems, and achieve current goals9. WM is a key cognitive process 
underlying the regulatory control component of dual process models 6 and is involved in the initiation, 
maintenance, and relapse stages of tobacco dependence10-16. Most notably, deficits in WM performance 
and activation in associated brain regions predict time to relapse13, 15 and strong WM has been shown to 
reduce the effect of craving on the ability to resist smoking16. Given this relationship, individuals with 
tobacco dependence are likely to benefit from interventions that strengthen WM.  Recently, several 
studies have demonstrated that increasing WM capacity through WM training (WMT) is associated with 
positive outcomes in several populations with substance use or impulse control disorders. Specifically, 
studies have demonstrated that WMT is associated with decreased: delay discounting in substance 
users17, weight re-gain after a weight loss program18, and alcohol use in heavy drinkers19.  
 
A second emerging innovation in the treatment of addictions is repetitive Transcranial Magnetic 
Stimulation (rTMS), a procedure which sends magnetic pulses through the scalp to stimulate neuronal 
tissue20 resulting in observed changes in neuronal plasticity21 and striatal dopamine22. rTMS has now 
demonstrated positive effects in several substance use disorders including nicotine, alcohol, and 
stimulant dependence23, 24. This procedure has been shown to be effective in reducing smoking urges in 
abstinent as well as satiated smokers25, 26 and to reduce cigarette consumption25, 27. While promising 
results for this treatment have been demonstrated, the size and durability of the therapeutic effect may be 
limited25. Additionally, the mechanism by which rTMS exerts positive effects on smoking outcomes is 
unknown. Recently it has been posited that changes in WM performance resulting from rTMS may be the 
key pathway to its observed effects on smoking related outcomes28, and furthermore that WMT 
administered in close temporal precedence to rTMS may result in an additive or supra-additive effect in 
treating addictive processes6. However, these hypotheses have not been tested to date despite their 
importance for understanding and improving the clinical impact of these emerging therapeutic modalities 
for treating addictive behaviors. Interventions with the ability to effectively target self-control processes 
fill in a critical gap in currently available treatment options6, 29. 
 
C. Experimental Method 
C1.  Brief Description of Subjects 
Smokers endorsing at least moderate dependence30 (total score > 4), and endorsing no specific plan to 
quit smoking in the next 3 months, will be randomized to one of 4 groups detailed above. Participants will 
be recruited from the local community using flyers, newspaper advertisements, and online advertising, 
including Trialfacts recruiting services. Eligible participants must meet the following inclusion / exclusion 
conditions: (1) meet safety guidelines for application of rTMS (2) be 18-60 years of age, (3) have smoked 
cigarettes regularly for at least one year, (4) currently smoke at least 10 to 30 cigarettes per day, (5) have 
a carbon monoxide (CO) level >10 ppm, and (6) currently be using no other nicotine products. Subjects 
will be excluded if they: (1) meet criteria for current alcohol or substance dependence as assessed by the 
(MINI) International Neuropsychiatric Exam31, (2) have a current affective disorder (depression, 
dysthymia, or mania) or psychotic symptoms, (3) are currently pregnant or lactating, or intend to become 
pregnant, (4) have a health condition for which rTMS is contraindicated. 
 
C2.  Study Design 
Following the initial phone screen, eligible participants will be invited to participate in an eight-week 
study including a baseline visit, 20 WMT sessions, 10 rTMS stimulation sessions, mid-point and outcome 
assessments, and a 1-month follow-up assessment. Baseline assessment will include demographic 
measures and inclusion (including pregnancy testing), measures of smoking and other substance use 
characteristics, psychological/psychiatric measures, and neuropsychological and behavioral economic 
tasks. Following baseline assessment participants will be randomized to one of the four conditions 
detailed previously. Assignment to condition will be conducted using the Urn randomization procedure32, 

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33 to ensure balancing on baseline WM, nicotine dependence, and age. During the baseline assessment 
participants will be introduced to the WMT software, and instructed on how to access and utilize the 
software properly from remote locations. WMT/sham WMT will commence immediately following 
baseline assessment and will include 5 sessions per week for two weeks prior to rTMS/sham rTMS. 
Participants who do not complete 80% of WMT sessions during this period will be withdrawn from the 
study prior to initiation of rTMS and not followed further. In week three, participants will initiate rTMS 
resting motor threshold assessment (detailed below) and immediately begin stimulation sessions on 5 
consecutive days each week for two weeks, resulting in 10 sessions in total. WMT or sham will be 
completed immediately prior to, and immediately after rTMS or sham, in line with experimental designs 
examining additive effects of motor learning in the motor cortex during rTMS stimulation34. Participants 
will complete measures of craving and mood prior to and after each rTMS session. Participants will also 
be asked to complete online smoking measures, a behavioral economic task, and an index of WM 
performance after the first week of rTMS stimulation (mid-point assessment). Participants will be 
withdrawn if they miss more than one session per week, and primary analyses will focus only those 
participants completing the rTMS protocol. Partial completers will be included in secondary data 
analyses, using data up to the point of being withdrawn. Studies utilizing a similar design reported 
successful completion of 10 sessions of rTMS for 48 out of 52 participants (92%) 24. In calculating 
recruitment and sample size needs, we have conservatively assumed an attrition rate of 20%. Following 
the final rTMS stimulation visit, participants will be asked to return to the laboratory, within 4 days, and 
complete final outcome measures repeated from baseline. Lastly, four weeks following final assessment 
day, participants will be asked to complete online measures of mood, craving, cigarette and alcohol use, 
behavioral economic indices of reward and decision making, and WM performance online or if they do 
not have access to a computer, they will be able to access computers to complete the assessments at the 
CAAS study site.  
 
Specific Procedures or Sessions 
 
C.3.1 The Working Memory Training condition: This condition will include 20 sessions across 4 weeks 
(10 remote sessions prior to initiation of the rTMS stimulation, and 10 in lab sessions on rTMS 
stimulation days). Participants will be trained on how to remotely access the WMT training tasks during 
the initial baseline session, and provided with recommendations on when and where to complete the 
trainings. Remotely accessed WMT has been shown to be effective in previous studies19. Participants will 
be given the option to utilize computers in the laboratory at CAAS if they do not have access to personal 
computers. Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a 
backward digit span task, and a letter span task35 19. In the training condition, the difficulty level of all 
three WM tasks will be automatically adjusted on a trial-by-trial basis. Initially, each task will involve 
sequences of three items19. The length of the sequences will then be increased and decreased according to 
the participants’ performance; highest performance in each session is recorded by the software. In the 
Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the 
initial easy level throughout each task (i.e., three items in each sequence) 19. All other aspects of the 
condition are identical to the true WMT condition. An identical protocol and software have demonstrated 
efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive 
behavior19.  
 
C.3.2 The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film 
Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, 
with 15 second inter-train interval, for a total of 2000 pulses per session, resulting in a total stimulation 
protocol time of approximately 13 minutes. Active or sham rTMS will be applied over the left DLPFC; 
corresponding with the standard “F3” location on scalp (F3=left frontal lobe, location #3 for electrode 
placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will 
occur on consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to 
induce a visible twitch in contralateral hand in at least 50% of stimulations, will be assessed on first day 

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of application. Sham rTMS will be identical to active treatment, with the exception that mu-metal plates 
attached to the sham coil block the magnetic field while providing a sensation of stimulation. 
 
Assessments and cognitive tasks include: 
 
C.4 MEASUREMENTS 
Assessment measures include 5 domains: (1) baseline demographics; (2) measures of smoking and (3) 
alcohol; (4) psychological / psychiatric measures; and (5) neuropsychological and behavioral economic 
tasks. In total, all baseline survey and behavioral measures take approximately 1.5 hours to complete.  
 
C.4.1 Screening and Demographic Measures: will include smoking data related to inclusion criteria, 
demographics, psychiatric evaluation via the MINI International Neuropsychiatric Exam31, and safety for 
rTMS.  
 
C.4.2 Smoking Measures: will include Smoking History/Dependence Questionnaire: Smoking history 
and life smoking patterns will be assessed as recommended by the National Cancer Institute consensus 
panel. The Fagerström Test for Cigarette Dependence will be used as a continuous measure of nicotine 
dependence36. The Nicotine Withdrawal Symptoms Scale will be used to assess acute withdrawal from 
nicotine37. The Brief Questionnaire of Smoking Urges will be utilized to measure smoking urges, and also 
assess urge to drink water, eat candy, and drink caffeine to allow for specificity in measurement38. The 
Importance and Confidence to Quit Scale will be administered to assess participants' perceived 
importance and confidence for reducing or quitting smoking39. Carbon monoxide levels will be assessed 
using a Bedfont Scientific Smokelyzer®. The Cigarette Purchase Task40, 41, will be used to assess 
behavioral economic cigarette demand. The Delay to Smoking Analogue Task1, 42 is a 50-minute 
behavioral choice paradigm in which participants earn monetary rewards for delaying initiation of 
cigarette smoking in 5-minute increments, following a 3-hour smoking deprivation period. Craving for 
smoking is assessed during the task. This task was chosen for its ability to provide an excellent analogue 
to smoking relapse in real world settings43, and demonstrated sensitivity to effects of manipulation and 
intervention including stress, alcohol use, and medications42-45.42-45. 
 
C.4.3 Alcohol Measures: will include The Timeline Follow-back Interview will be used to assess alcohol 
use over the prior 60 days46. Short Inventory of Problems (SIP) will be used to assess the extent to which 
subjects have experienced problems related to their alcohol use over the past 3 months47. 
 
C.4.4 Psychological Measures: will include The UPPS-P Impulsive Behavior Scale: a self-report that 
assesses five subscales that are used to measure distinct dimensions of impulsive behavior48. The Positive 
and Negative Affect Scale will be administered to measure changes in affect49. Symptoms of depression, 
anhedonia, and anxiety will be assessed using the Center for Epidemiologic Studies –Depression Scale50, 
SHAPS Anhedonia scale51, Beck Anxiety Inventory52, Inventory of Depressive Symptomatology (IDS-SR), 
and Generalized Anxiety Disorder 7 assessment (GAD-7), respectively.    
 
C.4.5 Neuropsychological and Behavioral Economic Measures: WM Capacity will be measured using 
the same tasks that are used during WMT. However, the assessment versions of the three tasks will end 
when participants are unable to reproduce a sequence on two consecutive trials. Additionally, WM 
capacity will be measured in terms of accuracy, reaction time, and number of errors, using the National 
Institute of Health Examiner computerized N-back task53. The n-back is a well-established index of WM54; 
this paradigm focuses on flexible updating capabilities; the NIH Examiner assessment includes a spatial 1-
back and 2-back task requiring maintenance and updating. The Experiential Discounting Task (Delay 
Discounting) is a behavioral economic measure for assessing state in subjective value of rewards as a 
function of delay, with greater discounting of value indicative of decreased executive control processes55. 
Lastly, data on participant perception of assigned condition will be collected at final assessment to assess 
effectiveness of sham. 
 
 

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C5.  Data Analysis  
In order to test Aim 1 and 2 regarding the effects of condition on main outcomes, multiple regression will 
be utilized to examine the effects of dummy coded condition (WMT + rTMS, sham WMT + rTMS, WMT + 
sham rTMS, sham WMT + sham rTMS) on outcome measures of smoking as measured by the smoking 
analogue task and WM performance as measured by the N-back task, controlling for baseline measures of 
these variables. Secondary analysis will be conducted to examine the durability of effects of condition on 
WM performance at one month follow up and whether sex moderates the effects of condition at final 
assessment and follow-up; however, no specific hypotheses are made given the lack of data in the extant 
literature. In order to test Aim 3, regarding the indirect effects of condition on primary outcomes through 
WM and craving, mediation analysis with bootstrapping and replacement (Preacher & Hayes, 2008) will 
be utilized. Bias-corrected bootstrapping with 1000 bootstrap samples will be used for its ability to 
maximize the power to detect mediation 56-58. This modeling technique estimates simultaneous regression 
analyses and generates confidence intervals that correct for bias in estimating the indirect effects. An 
indirect effect is determined to be statistically significant if the confidence interval does not contain zero. 
 
D. 
Material Inducements 
Participants will be paid up to $540 in total for participating in this study utilizing Clincard© payment 
technology (confidential debit cards that are loaded with funds electronically after each session) or a 
similar confidential debit card, or cash. Specifically, participants will be paid $50 for completing the 
baseline appointment in the lab, $4-8 for each of the 10 online cognitive training sessions, $23-31 for each 
of the 10 rTMS sessions at Butler, $10 for completing the online midpoint assessment, $70 for the 
outcome assessment session, and $20 for the final online assessment session. 
 
E.   Training of Research Personnel 
The Principal Investigator (William Lechner) will work with the co-investigator (Dr. Linda Carpenter) 
who is Butler Hospital TMS Service Chief. Together they will ensure all research study staff have been 
trained and are competent in the safe use of the rTMS device for this trial as well as proper administration 
of the working memory training protocol and all assessments. All research staff are adequately trained for 
various roles delegated in the conduct of this study (e.g., clinical interviews, diagnosis and symptom 
assessment, data collection, and communication of clinical information with other care providers).  
 
3)  Human Subjects 
A. Human Subjects Involvement, Characteristics, and Design: Participants for the proposed study will be 
130 adults, aged 18-60, who are currently nicotine dependent and physically eligible to undergo rTMS 
procedures. Participants will be recruited from the Providence, RI community using flyers, newspaper 
advertisements, and other advertising methods including online advertisements and social media. 
Participants will be screened over the phone, or via online survey for major exclusion criteria and eligible 
participants will then be invited to the lab for a screening and baseline assessment visit. Following 
instruction from staff, participants will engage in ten remote working memory training sessions for a two-
week period, following by 10 sessions of combined working memory and rTMS application over the 
subsequent two weeks. Participants will then engage in a final outcome session in the laboratory and a 
follow up session completed online 4 weeks after final outcome.  
 
Inclusion Criteria: Eligible participants must meet the following inclusion / exclusion conditions: (1) to 
ensure subjects can safely receive rTMS, eligible subjects must meet all established screening criteria for 
safety during MRI (magnetic resonance imaging), since MRI involves magnetic fields at similar intensity 
to those emitted from the rTMS stimulation coil. These are conservative measures that require a patient 
not have following (unless MRI-safe): Cardiac pacemaker; Implanted device (deep brain stimulation) or 
metal in the brain, cervical spinal cord, or upper thoracic spinal cord (2) be 18-60 years of age, (3) have 
smoked cigarettes regularly for at least one year, (4) currently smoke at least 10 to 30 cigarettes a day (5) 
have a carbon monoxide (CO) level >10 ppm at the initial assessment (6) Currently be using no other 
tobacco products or nicotine replacement therapy.  

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Exclusion Criteria: Subjects will be excluded if they: (1) meet criteria for current alcohol or substance 
dependence as assessed by the MINI (2) have a current affective disorder (depression, dysthymia, or 
mania) or have psychotic symptoms as assessed by the MINI (3) are currently pregnant or lactating, or 
intend to become pregnant (4) have a health condition or are taking a medication for which Transcranial 
Magnetic Stimulation is contraindicated including a lifetime history of loss of consciousness due to head 
injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury 
with documented evidence of brain injury (including brain atrophy). 
 
B.  Recruitment and Consent Procedures  
Participants will be recruited from the local community using flyers, newspaper advertisements, and 
other advertising methods including Trialfacts recruitment services, which utilizes online advertising and 
social media advertising to recruit participants. At the start of the baseline session, research staff will 
review the consent form with potential participants. The purpose and procedures of the study will be 
fully explained both orally and in writing. The consent form assures participants that they can discontinue 
their participation at any time without any adverse consequences, that all of the information they provide 
will remain confidential.  Furthermore, they will be informed that the signed consent form will be filed 
separately from all assessment information and that their data will be marked with a code number and 
not their name.   
C.  Potential Risks   
Overall, the risks of this study are considered minimal, and include (1) known risks associated with rTMS 
outlined below (2) possible emotional discomfort from answering sensitive questionnaire items and (3) 
breaches of confidentiality.  
 
(1) Risk of side effects from rTMS sessions: During sessions, patients may experience a sensation of 
tapping or painful sensations around the place where the stimulation coil is positioned on the head. 
Most patients who have had rTMS or TMS therapy usually report these sensations to be mild and find 
they diminish over time as their body adjusts to the daily stimulation procedure. Other possible side 
effects associated with rTMS delivered to this standard target on the head are scalp, jaw, face, or neck 
discomfort or muscle twitching in those area, toothache, and headache. Some stimulation coil 
adjustments may be possible to make the experience more comfortable. Over-the-counter pain 
medications such as Tylenol (acetaminophen) or Motrin (ibuprofen) have proven helpful for reducing 
discomfort from rTMS stimulation. When rTMS has been delivered to areas of the brain outside of the 
target location where the coil is placed in this study, there have been reports of transient dizziness, 
fainting, and brief changes in attention and thinking. These are considered extremely rare and highly 
unlikely to occur in subjects who receive this level of stimulation to the left prefrontal cortex as 
planned in this study. Assessment of the subjects’ well- being and functioning before and after each 
session, special positioning and targeting procedures to ensure the coil is placed over the target brain 
region and constant monitoring during each session, will all be done to minimize the risk of 
experiencing these side effects. 
Because the device can emit a loud clicking noise during sessions, all subjects will wear protective 
earplugs or occlusive earbuds during their sessions. Studies done with rTMS therapy delivered by the 
TMS device has shown that standard applications of the type delivered in this study are not associated 
with permanent loss of hearing or changes in ability to hear. 
 
Risk of Seizure: It is estimated that in ordinary clinical use, standard rTMS sessions (delivered in the 
same general location of the brain and with the same strength that will be used in this study) have 
caused a seizure in approximately 0.1% of patients, representing a risk of seizure in approximately 1 
in 30,000 sessions. The rTMS sessions in this study will be given by doctors and staff who have 

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extensive experience with safe delivery of rTMS and who are trained in steps to prevent and manage 
seizures. Medical personnel and equipment are available to monitor subjects and apply first-aid 
procedures if a seizure occurs at Butler Hospital. Most seizures last only a few minutes and 
spontaneously end, with the patient in a somewhat confused state that resolves over several hours. 
Management of a seizure during an rTMS application may involve transferring patients to a local 
emergency room or to another facility for further evaluation, if that is determined to be necessary by 
the study doctor. Having a seizure may lead to a potential effect on a person’s future employability 
and ability to drive. Should a subject experience a seizure that is related to rTMS application in this 
research, a study physician will provide him or her with a letter stating that the seizure was produced 
under specific brain stimulation conditions in this study, and that there is no reason to expect another 
seizure would occur when not receiving rTMS applications. In case of injury we offer the care needed 
to treat any injury that results directly from taking part in this research study. We reserve the right to 
bill insurance company or third parties, if appropriate, for the care related to the injury. We will try to 
have these costs paid for, but the participant may be responsible for some costs related to injuries 
incurred during the study.   
 
Risk of Inconvenience and Burden of Required Time/Travel: Subjects may engage in screening 
procedures and learn they are not eligible for participation in the research session trial. Frequent 
visits to the research clinic for the rTMS sessions (3 consecutive days) may represent a considerable 
inconvenience, especially if a subject travels a great distance or has other constraints on their time or 
transportation. A small payment will be offered to cover part of the subject’s expenses related to 
participation in this research study, but subjects will not be offered reimbursement for all of the 
expenses they may incur. 
 
(2) Some questionnaire items used may be considered sensitive to some participants (disclosing 
information about their drinking habits), and as such, may result in distress. However, care has been 
taken to minimize these risks by making these procedures explicit during the informed consent 
process, by noting their use in the instructions on specific tasks, and by reminding participants of 
their right to withdraw from the study at any time. These risks are thought to be minimal.  
(3) Breach of confidentiality (judged highly unlikely). The risks of a breach of confidentiality will be 
addressed by emphasizing that information obtained during assessments is confidential and will be 
used solely for research. All participant data collection related to surveys and psychological measures 
will be collected via online assessment surveys (Qualtrics secure data collection program). 
Additionally, data collected for the working memory training task will be collected through a secured 
server with no identifying information stored on the server. In addition, all records will be kept in 
locked or password-protected files, and stored in either locked offices and/or secure servers 
maintained by Brown University (121 South Main St., Providence, RI) or the Neuromodulation 
Laboratory at Butler Hospital (345 Blackstone Blvd., Providence, RI). These records will be accessed 
only by essential study staff who are trained in human subject’s protection guidelines; clinical 
information regarding administration of rTMS will be documented in the Butler Hospital Medical 
Record according to institutional policy. In addition, all questionnaire data will contain only numeric 
codes, with identifying information and link codes kept in a separate, password-protected database. 
All assessment procedures will be closely supervised, and study staff will be trained and reminded of 
the need to keep all information confidential. No names will be used in presenting data in lectures, 
seminars, and papers. In order to protect participants confidentiality related to email communication 
all email links containing any PHI will be sent through CNE secure portal and participants will be 
asked to sign the consent for email communication in a research project form (in appendix) prior to 
any email communication. Basic study info (not containing any PHI) will be communicated through 
the study email account (brownworkingmemory@gmail.com). This email address will be named in 
the email consent, which participants may opt out of.  

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E. Protection of the Subject (include: D.1. measures to minimize potential risks; D.2 measures to ensure 
confidentiality; D.3. data safety monitoring plan) 
 
B. Protections against risks: Comfort and Safety during TMS procedures: An appropriately trained staff 
member will administer each session and be present throughout application sessions to observe the 
participants under the direct supervision of a TMS-credentialed physician at Butler Hospital. Serial 
assessment of side effects at each TMS session will be used to identify and address any application-
emergent adverse effects. Topical anesthetic cream and use of over the counter nonsteroidal analgesics 
(acetaminophen, ibuprofen, etc.) may be recommended for those who experience significant scalp pain. 
Risk of seizure and other serious adverse events related to stimulation will be mitigated by careful 
screening of past health history, identification of underlying risk factors, and application of the study 
inclusion/ exclusion criteria. The TMS safety screening process, which includes screening for presence of 
implanted ferromagnetic metal in potential TMS patients, will be documented per Butler Hospital policy 
and approved procedures for TMS Therapy. Patients will be provided with ear protection (earplugs or 
earbuds) during sessions to reduce risk of discomfort or harm from loud clicking sounds emitted from the 
device during stimulation. 
All information obtained during the online assessment and laboratory sessions is confidential and will be 
used solely for research purposes. All digital records will be collected via Qualtrics survey software and 
FileMaker Server. The FileMaker Server will be hosted on Brown’s secure server and will be password-
protected to ensure that only essential research staff will have access Qualtrics survey data will be 
downloaded weekly, and entered into a password protected data file that will be stored on the Brown 
University servers (121 South Main St., Providence, RI); clinical information regarding administration of 
rTMS will be documented in the Butler Hospital Medical Record according to institutional policy. Study 
items and participant contact information will be collected in separate surveys. In a separate database 
(which is itself password-protected), participants’ identifying and contact information will be stored and 
linked to a unique study code, which will be used to connect this information to their study data during 
the duration of the study. After all study procedures are complete, the database containing all participant 
identifying information, as well as their unique study codes, will be destroyed, resulting in a de-identified 
final dataset.  
Informed consent documents will be kept in a locked file that is available only to essential research 
personnel who have been trained in human subject’s protection guidelines. Any study measures that are 
collected on paper will contain only participants’ unique study ID numbers, and no identifying 
information, and will be kept in a separate, secure location. All research staff will be trained and reminded 
of the need to keep all information confidential. There are certain limitations to confidentiality relevant to 
the current study; confidentiality may have to be broken if imminent risk of suicide or homicide is 
discovered (i.e. imminent risk to self or others), or if legal authorities subpoena information or testimony 
from the investigators. In order to protect participants confidentiality related to email communication all 
email links containing any PHI will be sent through CNE secure portal and participants will be asked to 
sign the consent for email communication in a research project form (in appendix) prior to any email 
communication. Basic study info (not containing any PHI) will be communicated through the study email 
account (brownworkingmemory@gmail.com). This email address will be named in the email consent, 
which participants may opt out of. 
Data Safety and Monitoring Plan  

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Entities Conducting Monitoring: 
The Institutional Review Board (IRB) at Butler Hospital will review this protocol and all procedures and 
will provide oversight.  Monitoring will be done by the contact Multiple Principal Investigator, Dr. William 
Lechner, the Butler Hospital IRB, and an independent data and safety monitoring board (DSMB).  Drs. 
Kahler, Philip, and Carpenter (Co-I’s) will also participate in the administration of the monitoring plan.  
What is Monitored? 
Monitoring is done of all procedures to ensure that they conform to the approved protocol; of unforeseen 
circumstances that might arise and affect safety; of all reports of serious adverse events as defined in 38 
CFR 46 and the FDA 312.32 (death, life-threatening experience, new or prolonged hospitalization, 
persistent or significant disability/incapacity, or congenital anomaly/birth defect); of other significant 
adverse events (adverse events that lead to drop out by participant or termination by the investigator); of 
unexpected adverse events (i.e., an adverse drug experience that has not been previously observed) 
resulting from the study; and of expected adverse events.  
Monitoring is done of all study inclusion and exclusion criteria, specifically ensuring that female subjects 
who are pregnant, nursing, or not using effective methods of birth control will be excluded from 
participation. Subjects who test positive for pregnancy will be informed that they have had a positive test 
result and are not eligible to participate in the study.  They will be informed that it is possible to have a 
false positive and will be given information encouraging them to follow up with a medical provider of 
their choosing.  
During this clinical trial, we will notify officials, as mandated by law, if a participant reports intention to 
harm him/herself or others, or reports child abuse or abuse of an elder. In the event a participant was to 
report a need or interest in treatment for alcohol/substance dependence, psychiatric disorder, or distress, 
an appropriate referral to resources will be provided based on an extensive list of referral resources 
maintained by the study.  
All side effects of mild or greater severity will be reported to the study physician, a licensed physician 
employed by Butler Hospital who will be ultimately responsible for decisions to stop the application of 
transcranial magnetic stimulation and who will be available on call (this is an included service in the 
Butler Hospital Neuromodulation Facility contract). Participants will be encouraged as a first step to use 
over-the-counter medications to treat mild symptoms such as headache (acetaminophen). Assessment of 
the subjects’ well- being and functioning before and after each session, special positioning and targeting 
procedures to ensure the coil is placed over the target brain region and constant monitoring during each 
session, will all be done to minimize the risk of experiencing mild side effects. It is estimated that in 
ordinary clinical use, standard rTMS sessions (delivered in the same general location of the brain and 
with the same strength that will be used in this study) have caused a seizure in approximately 0.1% of 
patients, representing a risk of seizure in approximately 1 in 30,000 sessions. The rTMS sessions in this 
study will be given by doctors and staff who have extensive experience with safe delivery of rTMS and 
who are trained in steps to prevent and manage seizures. Medical personnel and equipment are available 
to monitor subjects and apply first-aid procedures if a seizure occurs at Butler Hospital. Most seizures last 
only a few minutes and spontaneously end, with the patient in a somewhat confused state that resolves 
over several hours. Management of a seizure during an rTMS application may involve transferring 
patients to a local emergency room or to another facility for further evaluation, if that is determined to be 
necessary by the study doctor. Having a seizure may lead to a potential effect on a person’s future 
employability and ability to drive. Should a subject experience a seizure that is related to rTMS 
application in this research, a study physician will provide him or her with a letter stating that the seizure 
was produced under specific brain stimulation conditions in this study, and that there is no reason to 

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expect another seizure would occur when not receiving rTMS applications. In case of injury we offer the 
care needed to treat any injury that results directly from taking part in this research study. We reserve 
the right to bill insurance company or third parties, if appropriate, for the care related to the injury. We 
will try to have these costs paid for, but the participant may be responsible for some costs related to 
injuries incurred during the study. Participants will be given a telephone number for calling the physician, 
and physician office hours will be available as needed. The physician will be responsible for determining 
whether transcranial magnetic stimulation should be discontinued and will inform the PI of this decision. 
Those discontinued from medication will continue to participate in the trial and in the follow-up 
assessments. 
Frequency of Monitoring: 
All adverse events will be continuously monitored by the PI.  Participants will be given contact 
information so that they can inform us of events that occur in between study visits.  Dr. Lechner will 
conduct daily oversight of participant safety. He will meet weekly with staff to review participant 
progress and their experiences with the experimental procedures, including adverse events.  Any adverse 
events that are observed and/or reported will be immediately reported to Dr. Lechner.  The IRB conducts 
the monitoring at the continuing reviews as scheduled, whenever modification requests are considered, 
and upon receiving reports of serious adverse events from the PI or anyone else.  NIDA monitors the 
study upon receipt of annual progress reports and whenever other information is received.   
The DSMB will review progress of the trial every six months after enrollment of the first participant until 
the completion of the study. Additional meetings will be convened quickly if problems arise that require 
addressing between reviews. 
Reporting Plan: 
Any serious adverse events that are observed and/or reported will be immediately reported to Dr. 
Lechner.  Serious adverse events are then reported to the Butler Hospital IRB and the NIH. All serious 
adverse events related to this study will be reported to the Butler Hospital IRB immediately by telephone 
and by written report within 48 hours of our receipt of information regarding the event.  All other 
adverse events related to the study will be reported at the continuing review.  Serious adverse events will 
also be reported in writing to the NIDA Project Officer and to the DSMB within 48 hours.  All serious 
adverse events and adverse events related to the study will be reported annually in the Progress Report 
sent to the NIDA Project Officer.    
Any actions taken by the IRB or DSMB, other than acceptance of the adverse event report, will be reported 
to NIDA along with any changes or amendments to the protocol requested by the IRB or DSMB in 
response to these reports.  Proposed changes or amendments to the protocol in general must be 
requested first in writing to the IRB, which will then grant or deny permission to make the requested 
change or amendment in protocol. NIDA will subsequently be informed of any substantive changes or 
amendments in approved protocol.   
(a) Procedures to ensure the validity and integrity of the data.  Several procedures currently in practice in 
our laboratory will also be utilized for this study to guarantee the validity, integrity, accuracy, and 
completeness of the data.  It will be made clear to all participants that all information obtained during 
assessments is confidential.   
(b) Procedures to guarantee the accuracy and completeness of the data during data collection, 
transmission, and analysis.  First, the Research Assistant will review each file within 2 days of data 
collection for completeness, accuracy, and validity of responses.  All scanned data will be verified by the 
Research Assistant using a computerized verification program. Data files are accessible only to project 

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personnel and are password protected.  The Research Assistant will review the distributions of all raw 
data to ensure that data are within range and to check missing data with the hard copy of the data. Finally, 
the project database (including uploaded data files from the laptop computer and scanner machine) is 
also password protected and accessible only to the project’s Senior Programmer/Analyst and PI.   
Members: The DSMB includes behavioral scientists with expertise in addictions who are not involved in 
the project. 
 
Board Chair: Jen Tidey, Ph.D. 
 
Other Members: Peter Monti, Ph.D., Damaris Rohsenow, Ph.D., Suzanne Colby, Ph.D. 
Conflict of interest. DSMB members will be asked to disclose any conflicts of interest prior to DSMB 
meetings. No DSMB members will have any role on the study.  
Meeting format. The meetings may include both open and closed sessions.  In the open sessions, the PI 
presents and discusses information with the DSMB on study progress and adverse events. In closed 
sessions, the DSMB chairperson leads the meeting with the board members and without participation of 
the PI or study investigators to discuss any concerns with the progress of the study or with risks to 
participants. The need for closed meetings are at the discretion of the DSMB chair.  
What is monitored. The DSMB will evaluate the progress of the trial, recruitment rates, retention rates, 
adverse events, unanticipated problems, and other factors affecting safety or outcomes. The DSMB will 
review rates of adverse events in the study (in an unblinded manner if they wish) to evaluate any changes 
in participant risk.  The DSMB also will review major proposed modifications to the study prior to their 
implementation. Once 50% of our desired sample size has completed the on month follow-up, interim 
outcome analyses will be run and presented to the DSMB. Differences in adverse events between the 
active and sham transcranial magnetic stimulation conditions will be compared to determine whether 
there are significant risks to participation that warrant altering the protocol or stopping the study. 
Confidentiality. The DSMB will not have access to personally identifiable information of participants.  
DSMB members agree not to disclose the results of the data except as agreed by the PI. The report to the 
DSMB includes actual vs. projected recruitment rates (number screened, consents, randomized, etc.), 
summary of serious adverse events and any modifications to the protocol.  After interim efficacy analyses 
are conducted, these will also be included in the reports. 
Frequency of meetings. The DSMB will review progress of the trial every six months after enrollment of 
the first participant until the completion of the study.  Additional meetings will be convened quickly if 
problems arise that require addressing between reviews.   
Communication plan.  At the end of each DSMB meeting, the chair will provide the study leadership with 
written information concerning findings for the trial as a whole related to problems or adverse events 
observed and any relevant recommendations related to continuing, changing, or terminating the 
study. The chair will prepare a summary of the meeting along with any recommendations for changes to 
the protocol based on the meeting.  The draft report will be reviewed and edited by all Board members 
prior to issuing the final report.  The PI will send the report to the IRB and to NIDA.  
E.  Potential Benefits  
Participants will be told that they should expect no personal benefit from participating in the study. 
Participants will be involved in research that has potential to inform interventions for smoking and 
benefit the scientific community.  
 
F.  Risk-Benefit Ratio  

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The risk-benefit ratio of this study is favorable. Risks of adverse events associated with the use of the 
rTMS device and other study procedures are minimal. Patients will be under the care and supervision of 
experienced research psychiatrists and will be seen by research staff for session assessment.  
 
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23. Bellamoli E, Manganotti P, Schwartz RP, et al. rTMS in the treatment of drug addiction: an update about human 
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dorsolateral prefrontal cortex reduces cigarette craving and consumption. Addition. 2009;104(4):653-660. 
26. Li X, Hartwell KJ, Owens M, et al. Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal 
cortex reduces nicotine cue craving. Biological Psychiatry. 2013;73(8):714-720. 
27. Eichhammer P, Johann M, Kharraz A, et al. High-Frequency Repetitive Transcranial Magnetic Stimulation 
Decreases Cigarette Smoking. The Journal of Clinical Psychiatry. 2003;64(8):951-953. 
28. Barr MS, George TP. Deep Repetitive Transcranial Magnetic Stimulation for Smoking Cessation: Is Going Deeper 
Better? Biological Psychiatry. 2014;76(9):678-680. 
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for alcohol use disorders. Neuropsychol Rev. 2013;23(1):27-47. 
30. Fagerström K. Determinants of tobacco use and renaming the FTND to the Fagerström Test for Cigarette 
Dependence. Nicotine & Tobacco Research. 2012;14(1):75-78. 
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35. Klingberg T. Training and plasticity of working memory. Trends in cognitive sciences. 2010;14(7):317-324. 
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38. Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory 
and clinical settings. Nicotine & Tobacco Research. 2001;3(1):7-16. 
39. Abar B, Baumann BM, Rosenbaum C, et al. Profiles of importance, readiness and confidence in quitting tobacco 
use. J Subst Use. 2013;18(2):75-81. 
40. Jacobs EA, Bickel WK. Modeling drug consumption in the clinic using simulation procedures: Demand for heroin 
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medications for smoking cessation. Nicotine Tob Res. 2012;14(11):1362-1371. 
45. McKee SA, Harrison EL, O'Malley SS, et al. Varenicline reduces alcohol self-administration in heavy-drinking 
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46. Sobell MB, Maisto SA, Sobell LC, et al. Developing a prototype for evaluating alcohol treatment effectiveness. In 
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47. Miller WR, Tonigan JS, Longabaugh R. The Drinker Inventory of Consequences (DrInC): An instrument for 
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48. Whiteside SP, Lynam DR, Miller JD, et al. Validation of the UPPS impulsive behaviour scale: a four-factor model of 
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50. Radloff LS. The CES-D Scale: a self-report depression scale for research in the general population. Anonymous 
Applied Psychological Measurement. New York, NY: West Publishing Co. 1977:385-401. 
51. Nakonezny PA, Morris DW, Greer TL, et al. Evaluation of anhedonia with the Snaith-Hamilton Pleasure Scale 
(SHAPS) in adult outpatients with major depressive disorder. J Psychiatr Res. 2015;65:124-136. 
52. Beck AT, Steer. RA. Manual for the Beck anxiety inventory. San Antonio, TX: Psychological Corporation 1993. 
53. Kramer JH, Mungas D, Possin KL, et al. NIH EXAMINER: conceptualization and development of an executive 
function battery. Journal of the International Neuropsychological Society. 2014;20(1):11-19. 
54. Brunoni AR, Vanderhasselt M-A. Working memory improvement with non-invasive brain stimulation of the 
dorsolateral prefrontal cortex: A systematic review and meta-analysis. Brain and Cognition. 2014;86:1-9. 
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57. Hayes AF, Scharkow M. The relative trustworthiness of inferential tests of the indirect effect in statistical 
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58. Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in 
multiple mediator models. Behavior research methods. 2008;40(3):879-891. 
 
5) CRITERIA FOR WAIVER OF AUTHORIZATION FOR USE OF PROTECTED HEALTH INFORMATION 
(PHI) 
 
5A. Does the requested use of PHI involve more than minimal risk to privacy? 
 YES [if " YES," project is not eligible for PHI Waiver]    
 NO [if "NO," address 1-3 below] 
 
Plan to Protect Patient Identifiers from Improper Use and Disclosure: 
PHI collected from callers during preliminary phone screening will be kept in protected research records 
that are accessible only by research staff directly involved in conducting this research study. 
 
Plan to Destroy Identifiers or Justification for Retaining Identifiers: 
PHI collected from subjects who do not go on to sign consent for study participation will be kept in de-
identified manner or destroyed.  
 
Assurances that the PHI will not be Re-used or Disclosed: 
PHI collected solely for screening and prior to informed consent will not become part of the hospital 
medical record or be available for re-use of disclosure. 
 
5B. Could the research be practicably conducted without a waiver? 
 
 YES    
 NO 
5C. Could the research be practicably conducted without access to and use of the PHI? 
 
 YES    
 NO 
5D. PHI is only needed for activities preparatory to research 
 
YES    
NO 
 
6) DESCRIPTION OF PHI TO BE COLLECTED UNDER WAIVER  
Demographics (Name, age, address), clinical characteristics, medical health/ history 
 
7) ADVERTISEMENTS 
See attached. 
 
8) INFORMED CONSENT FORM (ICF) 
See attached.   
 

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BUTLER HOSPITAL CONSENT FOR PARTICIPATION IN A RESEARCH PROJECT  
 
 Working Memory Training combined with Transcranial Magnetic Stimulation in Smokers: 2x2 Factorial. 
 
Sponsorship 
This study is being paid for by an external grant from The National Institute on Drug Abuse.  
 
 
Research Project Summary 
You are being invited to participate in a study designed to investigate how people respond to a cognitive 
training exercise in addition to repetitive transcranial magnetic stimulation (abbreviated “TMS” or 
“rTMS") in terms of their smoking behaviors. The cognitive training exercise is a computerized task which 
will exercise your thinking and memory skills. TMS is a non-invasive therapy that has been studied for 
over a decade.  It uses magnetic coils to deliver pulses of magnetic energy through the scalp to stimulate 
nerve cells in the brain (called neurons). TMS has been used in several studies examining its effects on 
cigarette smoking behavior and now we will examine the effects of TMS when it is delivered together with 
cognitive training, to see if there is any additional effect on the dependent variables of interest.   
 
You have been invited to participate because you indicated that you smoke between 10 and 30 cigarettes 
a day and have been a smoker for at least one year. Your participation in the study will last approximately 
2 months during which time you will complete online training sessions, and 12 sessions in our offices.   It 
will require approximately 5 hours per week of your time. In order to decide whether or not you wish to 
be a part of this research study, you should know enough about its risks and benefits to make an informed 
judgment.  This consent form gives you detailed information about the research study which a member of 
the research team will discuss with you.  This discussion should go over all aspects of this research:  its 
purpose, the procedures that will be performed, risks associated with the procedures, possible benefits of 
participation and possible alternatives.  Once you understand the study, you will be asked if you wish to 
participate; if so, you will be asked to sign this form.  This consent may contain words that you do not 
understand.  Please ask the investigator or the study staff to explain any words or information that you do 
not clearly understand. 
 
Description of Procedures 
If you decide to participate you will complete the following sessions: 
 
 Screening and Baseline Session (approximately 1.5 hours): 
You will be asked to complete several brief questionnaires about your nicotine, alcohol, and other drug 
use as well as your mood and symptoms of psychological disorders (such as depression). You will be 
asked to breathe into a tube that will measure the amount of alcohol and carbon monoxide on your 
breath. If you have any alcohol on your breath for today’s session, we will need to re-schedule your 
appointment. You will be asked to complete a computerized task that will measure your thinking 
performance including your memory, and you will complete two other computerized tasks assessing (1) 
how much money you would spend in different situations, and (2) how much you would spend on a 
cigarette in different situations. If all inclusion / exclusion criteria is confirmed, you will be eligible to 
participate in the rest of the study.  
 
 Online Training Sessions (approximately 15 minutes each): 
You will log in to our training program at home on your computer, or if you don’t have access to a 
computer with internet, in the lab at Brown. We will ask you to complete 5 cognitive training sessions 
each week (you can choose which 5 days out of 7 you complete the online training), over the course of 
two weeks, lasting about 15 minutes each. During these tasks your thinking capacity and memory will be 
exercised to various degrees. 

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 Laboratory Sessions at Butler Hospital (approximately 1.5 hours each): 
You will be asked to fill out a few brief questionnaires about your smoking and your mood, perform 
another thinking and memory exercise, and receive a 30-minute session of transcranial magnetic 
stimulation, which may include active or sham (no active stimulation). During the first session we will 
measure your “motor threshold” which is the minimum amount of energy from a single coil that will 
produce a slight movement in your hand half of the time. You will hear a clicking sound and feel a tapping 
sensation on your scalp during this procedure. Once you are seated comfortably in the TMS chair, you will 
be given ear plugs to wear since the TMS machine makes loud clicking noises. The TMS application coils 
will be placed on your scalp, over your hair, on the left side of your head just above your forehead. We will 
take a few measurements of your head to make sure we place the coil in the correct location. You will 
remain awake and alert throughout the session and a research staff member will be present with you in 
the room. You will receive 25 short series of stimulation, that last 8 seconds each; the stimulator will send 
10 pulses per second during these series. You will hear a clicking noise and you might feel a tapping 
sensation on your scalp where the coil is placed. These sessions may include active TMS stimulation in 
which magnetic pulses are transmitted through your scalp to stimulate neuronal tissue, or a sham 
procedure in which all study procedures are identical with the exception that no magnetic pulses will be 
transmitted through you scalp. All study staff and procedures are over seen by a doctor who is trained 
specifically in TMS and TMS safety, to make sure that you are safe at all times. It is possible that you might 
experience mild discomfort at the place on your scalp where a coil is place. If it is too uncomfortable, you 
can ask the staff to pause or stop during application at any time. Over-the-counter pain medications such 
as Tylenol (acetaminophen) or Motrin (ibuprofen) have proven helpful for reducing discomfort from 
rTMS applications. The application sessions will last about 20-30 minutes. At the end, you will fill out a 
few more brief questionnaires and complete another thinking and memory exercise. You will be asked to 
come in for 5 sessions on consecutive days, for the course of two weeks (10 sessions in total). It is 
important that you come in for all ten sessions in a row.  
 
 Final Outcome Assessment Session (approximately 4 hours): 
This will be scheduled once you have completed the week of computerized cognitive training, and the 
week of 3 TMS sessions. During this session we will ask you to complete more smoking, alcohol, and 
mood questionnaires, a thinking and memory performance task, and to take part in a task that will 
measure how long you can resist smoking. As part of this task, there will be a time when you can choose 
to smoke your own cigarettes. Therefore, it is important that you bring a pack of your own cigarettes on 
this day. During this time, you will have an opportunity to earn money (up to $10) for delaying smoking 
for up to 50 minutes.  
 
 Online Survey Sessions (approximately 20 minutes): 
This will be administered twenty-one days after you complete the initial working memory training 
session, and one month after the final laboratory-based outcome assessment. These surveys will be sent 
in an email with a link to an online survey.  These surveys can be completed on your own using any 
computer to connect to the internet or at the research office if you prefer. We will protect your 
confidentiality by using a secure CNE Portal to email you all information related to this session; we will 
also ask you to sign a separate email consent in addition to this consent. If you choose to not use email 
you can complete these forms at our Brown offices (121 South Main St., Providence, RI). The surveys 
should take about 15-20 minutes to complete. 
 
Risks and Inconveniences   
The questionnaires used in this study have been used in other similar research studies. Some of the 
questions may be of an embarrassing or sensitive nature and may make you uncomfortable. Therefore, 
you are free not to answer any questions you do not wish to answer. Additionally, rTMS is associated with 
some risks outlined below: 
 

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 Risk of Side Effects from TMS Sessions:  
During sessions, you may experience a sensation of tapping or painful sensations around the place where 
the application coil is positioned on your head. Most patients who have had TMS therapy usually report 
these sensations to be mild and find they diminish over time as their body adjusts to the daily stimulation 
procedure. Other possible side effects associated with TMS applied to this area of the head are scalp, jaw, 
face, or neck discomfort or muscle twitching in those areas, or toothache, or headache.  Over the counter 
pain medications such as Tylenol (acetaminophen) may be helpful for reducing discomfort from TMS. 
When TMS has been delivered to other parts of the brain, there have been reports of temporary dizziness, 
fainting, and brief changes in attention and thinking. These are considered extremely rare and highly 
unlikely to occur with the type of TMS protocol being used in the current study. Assessment of your well-
being will occur before and after each session to ensure your safety and minimize your risk of 
experiencing these side effects.   
 
 Risk of Seizure:  
It is estimated that in ordinary clinical use, standard TMS applications (delivered in the same general 
location of the brain and with the approximate strength that will be used in this study) have caused a 
seizure in approximately .1% of patients, representing a risk of seizure in approximately 1 in 30,000 
applications. The TMS applications in this study will be given by doctors and staff who have extensive 
experience with the safe delivery of TMS and who are trained in steps to prevent and manage seizures. 
Medical personnel and equipment are available to monitor subjects and apply first-aid procedures if a 
seizure occurs at Butler Hospital. Most seizures last only a few minutes and spontaneously end, with the 
patient in a somewhat confused state that resolves over several hours. Management of a seizure during a 
TMS session may involve transferring patients to a local emergency room or to another facility for further 
evaluation, if that is determined to be necessary by the study doctor. Having a seizure may lead to a 
potential effect on a person’s future employability and ability to drive. Should you experience a seizure 
that is related to TMS application in this research, a doctor will provide you with a letter stating that the 
seizure was produced under specific brain stimulation condition in this study, and that there is no reason 
to expect another seizure would occur when you are not receiving TMS application.  
 
 Risk of Inconvenience and Burden for Time / Travel:  
You may engage in screening procedures and then learn you are not eligible for participation in the 
research trial. Emotional discomfort may be associated with completing the assessments and 
questionnaires. Frequent visits to Butler Hospital for 5 days in a row may represent an inconvenience, 
especially if you travel a great distance or have other constraints on your time or transportation. A small 
payment will be offered to cover part of your expenses related to participation in this research study, but 
you will not be offered reimbursement for all of the expenses you may incur.  
 
There may be other risks that are currently unknown. Although TMS has been used for many years, the 
long-term effect of TMS on individuals are not completely known.  If you have any medical issues you 
should first contact your primary care physician, psychiatrist, or another mental health professional.  
A TMS-trained physician will oversee all TMS research sessions and is available immediately for urgent 
medical issues. You will be given information about how to contact the TMS medical staff outside of 
regular work hours. 
 
Benefits 
We cannot and do not guarantee or promise that you will receive any benefits from this study.  We are 
testing for changes in your thinking (working memory ability) after the computer tasks and rTMS, which 
might relate to improvement in smoking. Additionally, you will have a chance to contribute to a scientific 
study that may help people in the future.  
 

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Any medical treatment or procedure may have unforeseen side effects.  You should know that the 
prediction of effects from a treatment or procedure for any individual cannot be done with certainty, and 
unexpected potentially harmful effects occasionally occur with the administration of any type of 
treatment.  If you have questions about investigational procedures or treatments, or if you experience any 
disturbing side effects during participation in the study, inform study personnel.   In the event of any 
unexpected, potentially harmful effects of any treatment or procedure administered in this study, we will 
monitor your condition closely and institute appropriate treatment.  If significant new knowledge is 
obtained through the course of the research which may impact your willingness to continue participation, 
you will be informed of this knowledge.   
 
Women Please Note:  Repetitive Transcranial Magnetic Stimulation (rTMS) is not recommended for use 
during pregnancy.  rTMS may be harmful to a developing fetus. Therefore, you may be tested for 
pregnancy at the time of your admission to the study.  Prior to your beginning the study we will discuss 
with you in more detail the importance of avoiding pregnancy.  We will specifically ask you to let us know 
if you change your mind and decide to become pregnant during the study. 
 
Confidentiality 
Information about you collected as part of this research will not be used or distributed for future research 
studies, even if personal identifiers are removed. 
 
Participation in this study and information gathered from the study, including online assessments, will be 
kept confidential.  A cross-index of your name (with address and telephone number) and your code 
number will be kept in a separate locked location, available only to the Brown University investigators 
and employees on this project. Specifically, these records will be kept in locked or password-protected 
files, and stored in either locked offices and/or secure servers maintained by Brown University (121 
South Main St., Providence, RI) or the Neuromodulation Laboratory at Butler Hospital (345 Blackstone 
Blvd., Providence, RI). These records will be accessed only by essential study staff who are trained in 
human subject’s protection guidelines. This cross-index will be destroyed once the final study data set is 
completed. In addition, all questionnaire data will contain only numeric codes. Clinical information 
regarding administration of rTMS will be documented in the Butler Hospital Medical Record according to 
institutional policy. To further protect your confidentiality, we will refer to ourselves during all telephone 
calls as “Brown University” and will not use any other identifying information. The findings of the study 
may be published but individual participants will not be identified. Any reports related to child 
abuse/neglect or elder abuse will be reported by us to the appropriate authorities. There are other 
limitations to confidentiality relevant to the current study; confidentiality may have to be broken if 
imminent risk of suicide or homicide is discovered (i.e. imminent risk to self or others), or if legal 
authorities subpoena information or testimony from the investigators. In order to protect your 
confidentiality related to email communication all email links containing any PHI will be sent through a 
secure portal and participants will be asked to sign a separate consent for email communication in a 
research project form prior to any email communication. 
 
You will not be personally identified in any reports or publications that may result from this study.  The 
confidentiality of the information you provide to us will be maintained in accordance with state and 
federal laws.  If you tell us something that makes us believe that you or others have been or may be 
physically harmed, we may report that information to the appropriate agencies.   
 
Clinically relevant research results, including individual research results, will not be disclosed to you. 
 
The U.S. Food and Drug Administration (FDA) may inspect all study records to ensure that the study is 
being conducted in accordance with FDA regulations. General information about this study has been or 

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will be submitted to the federal clinical trial registry databank, which can be accessed on the Internet at 
www.ClinicalTrials.gov."  
 
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The 
researchers with this Certificate may not disclose or use information, documents, or biospecimens that 
may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, 
suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have 
consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be 
disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local 
law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, 
state, or local civil, criminal, administrative, legislative, or other proceedings, see above); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other scientific 
research, as allowed by federal regulations protecting research subjects.  
 
Authorization for use/disclosure of your Identifying Health Information, to Conduct this Research Study 
If you sign this document, you give permission to research staff in the Transcranial Magnetic Stimulation 
Clinic at Butler Hospital to use your health information that identifies you, for the purpose of conducting 
the research study described above.  
 
The health information that we may use or share with others for research purposes includes information 
in your medical record, results of physical examinations, and medical history as needed to determine your 
eligibility and safety to receive repetitive transcranial magnetic stimulation.   
 
Your health information may also be shared with a public health authority that is authorized by law to 
collect or receive such information for the purpose of preventing or controlling disease, injury, or 
disability, and conducting public health surveillance, investigations, or interventions. The U.S. Food and 
Drug Administration (FDA) may inspect all study records to ensure that the study is being conducted in 
accordance with FDA regulations.  
 
Butler Hospital is required by law to protect your health information. Individuals outside of Butler that 
receive your health information may not be required by Federal privacy laws (such as the HIPAA Privacy 
Rule) to protect it, so we cannot guarantee that they will not share it without your permission. 
 
Please note that:  
 You do not have to sign this consent form, but if you do not, you may not participate in or receive 
research-related treatment in this study.   
 Butler Hospital may not withhold treatment or refuse to treat you, based on whether you sign this 
consent form.  
 You may change your mind and revoke (take back) this consent and authorization at any time. If 
you no longer want to give us permission to use your health information for this research study, 
you must contact the Principal Investigator, [William Lechner, contact information listed next to 
the signature line of this form], and you will be instructed to provide a written statement. You may 
need to write a separate statement to other institutions or organizations if health information 
about you related to this study is maintained in records outside of Butler. 
 Even if you revoke (take back) this consent and authorization, Butler researchers may still use or 
share health information about you that they already have obtained, when doing so is necessary 
to maintain the integrity or reliability of the current research.  
 You generally will not have access to your personal health information related to this research until 
the study is completed. At the conclusion of the research and at your request, you will have access 
to your health information that Butler Hospital maintains in a designated record set, according to 
the Notice of Privacy Practices provided to you by Butler Hospital. The designated record set 

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includes medical information or billing records used by doctors or other health care providers at 
Butler Hospital to make decisions about individuals.  
 Your health information will be provided to you or to your physician if it is necessary for your care.  
 If all information that does or can identify you is removed from your health information, the 
remaining information will no longer be subject to this authorization and may be used or 
disclosed for other purposes. 
 
This Authorization will expire when all the activities associated with this research study have concluded. 
 
Economic Considerations   
You will be paid up to $540 in total for participating in this study. Specifically, you will be paid $50 for 
completing the baseline appointment in the lab, $4-8 for each of the 10 online cognitive training sessions, 
$23-31 for each of the 10 rTMS sessions at Butler, $10 for completing the online midpoint assessment, 
$70 for the outcome assessment session, and $20 for the final online assessment session. 
 
Depending on the amount of payment you might receive for your participation in this study you might 
have to provide your name, address, and taxpayer ID or Social Security number to the Butler/CNE 
Research Accounting Department or Brown University Accounting Department. In order to receive 
payment of $300 or more for participation in research, you will have to complete and sign a W-9 form.  If 
you are paid $600 or more in any calendar year for research participation, the IRS will be notified of the 
total amount you were paid, in accordance with federal regulations. You should ask the researcher for 
more information if you have questions about this process. 
 
In Case of Injury   
We will offer you services in Care New England facilities as needed to treat any injury that results directly 
from taking part in this research study.  We reserve the right to bill your insurance company or other 
third parties, if appropriate, for the care you get for the injury.  We will try to have these costs paid for, 
but you may be responsible for some of them.  For example, if the care is billed to your insurer, you will be 
responsible for payment of any deductibles and co-payments required by your insurer.   
 
Injuries sometimes happen in research even when no one is at fault.  There are no plans to pay you or give 
you other compensation for any injury, should one occur.  However, you are not giving up any of your 
legal rights by signing this form.   
 
If you think you have been injured or have experienced a medical problem as a result of taking part in this 
research study, tell the person in charge of this study as soon as possible.  The researcher’s name and 
phone number are listed on the last page of this consent form.    
 
Alternative Treatments/Alternative to Participation  
This research study is not intended to provide treatment. Standard care for smoking cessation or mental 
health problems is available from doctors or clinics. Your care at Butler Hospital will not be affected in 
any way if you decide not to participate in this research study. 
 
Financial Disclosure   
None.  
 
Voluntary Participation 
You are free to decide whether or not to participate in this study, and you are free to withdraw from the 
study at any time.  A decision not to participate or to withdraw from the study will not adversely affect 
your current or future interactions with Butler Hospital or Care New England. Your participation in the 

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study may be terminated by the researchers without regard to your consent; in that case, you are entitled 
to an explanation of the circumstances leading to that decision. 
 
Questions 
Taking part in this study is entirely voluntary. We urge you to discuss any questions about this study with 
our staff members. You should take as much time as you need to make your decision. If you decide to 
participate, you must sign this form to show that you want to take part.  

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Authorization:  I have read this form and decided that   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
(printed name of participant) 
will participate in the project described above.  Its general purposes, the nature of my 
involvement, and possible hazards and inconveniences have been explained to my satisfaction.  
My signature also indicates that I have received a copy of this consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
___________________________________________ 
Signature of Participant  
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Principal Investigator  
 
 
     
 
 
 
 
Date 
 
 
 
 
or 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent  
 
          
 
 
 
Date 
 
Telephone Number of Principal Investigator or Person Obtaining Consent:__________________________ 
 
If you have further questions about this project or about research-related injuries, please contact 
William Lechner, PhD at 814-450-1093.  If you have questions about your rights as a research 
subject, please contact Paul Malloy, PhD., Vice Chair, Butler Hospital Institutional Review Board, 
at 401-455-6355. 
THIS FORM IS NOT VALID UNLESS THE FOLLOWING 
BOX HAS BEEN COMPLETED BY THE IRB OFFICE 
 
 
THIS FORM IS VALID UNTIL 
 
 
    DATE: April 30, 2021 
 
 
    IRBNET ID# 1054787 
    BUTLER IRB REFERENCE# 1705-003 
 
 
    BY (ADMINISTRATOR):