Theta Burst Stimulation for Schizophrenia
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: Duke University

Theta Burst Stimulation for Schizophrenia 
NCT03288779
Document Date: May 4, 2018

Theta Burst Stimulation in Schizophrenia 
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1. Protocol Title – Theta Burst Stimulation in Schizophrenia
2. Purpose of the study
Aim1: Evaluate the effect of theta burst stimulation (TBS) on working memory (WM) in patients with 
schizophrenia. Hypothesis 1 – There will be significant improvement in WM compared to baseline with one 
session of TBS. 
Aim 2: Evaluate the effect of TBS on gamma and theta oscillations as measured from EEG. Hypothesis 2 – 
Increase in theta oscillation spectral power and decrease in spectral power of gamma oscillations with one 
session of TBS. 
3. Background and Significance
Schizophrenia is an illness known to have cognitive deficits, with a chronic and variable course. There is
extensive research on cognitive deficits, with working memory, processing speed and verbal memory being
some of the domains affected(1, 2). Some modalities of treatment that have been tried to reverse these
cognitive deficits are medications and cognitive behavioral therapy with minimal benefits (3). A few studies
have shown modulation of working memory with routine repetitive transcranial magnetic stimulation at
frequencies not exceeding 10 to 20 Hz of stimulation (4, 5). Other studies have shown the working memory
to be related to gamma oscillations. A few studies have also shown that transcranial magnetic stimulation
(TMS) modulates these gamma oscillations as well. There is an extensive body of literature that shows that
working memory has contributions from theta and gamma oscillations in the brain. Theta burst stimulation
(TBS) is a form of transcranial magnetic stimulation (TMS), that entrains gamma and theta frequencies in
the brain. It could be the most appropriate form of brain stimulation for improving cognition in
schizophrenia patients because it has been shown to modulate brain oscillations in small samples of
patients (6-9).  The area for targeting would be the dorsolateral prefrontal cortex which is the site of origin
of the gamma oscillations and plays a significant role in working memory (10, 11).
4. Design and Procedures
4.1 Study protocol overview 
The study is designed to be a pilot one evaluating the effect of TBS on WM in patients with schizophrenia. We 
plan to screen 20 subjects to have 10 participants.   
The participant is not responsible for any research-related costs. The participants will be under the purview of 
their physician who is responsible for the participant’s care. The clinical team will first contact potential 
participants before contact by study team. If subject would like to participate, then the study team will 
approach subject for the study. The study team will ask for participants’ permission to contact their primary 
care team on the psychiatry inpatient floor so that information can be provided to the primary care team 
regarding the participant’s enrollment during the study.  
 4.2 Screening 
We plan to recruit both inpatients and outpatients. 
To recruit inpatients, potential participants will be discussed with the primary care team caring for the patient 
on Williams’ Unit which is the inpatient psychiatry floor at Duke Medical Center.  Once a potential participant 
has been identified, the clinical team will first contact potential participant before contact by study team. If 

 
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subject would like to participate, a study team person will approach the patient, discuss the study and desire 
for participation in person with that individual on the inpatient unit. This will be done day 1. If agreeable the 
individual will be approached for consent on day 2. For consent, the study would be discussed with the patient 
by study personnel, and a member of the study team will administer the University of California, San Diego 
Brief Assessment of Capacity to Consent (UBACC) to ascertain validity of the consent given for the study. After 
providing informed consent participants will undergo a clinical assessment to confirm the inclusion/exclusion 
criteria.  
 
Outpatients who contact the study team (after seeing the study on clinicaltrials.gov will be screened over 
phone based on inclusion and exclusion criteria. If they fulfill criteria, they will be schedule for the experiment. 
We do not plan to actively recruit outpatients using study flyers or other materials. 
 
All female subjects in the reproductive age group will be tested for pregnancy using a commercially available 
test kit specified by Department of Obstetrics and Gynecology. The Pregnancy test must be negative to 
continue in the study. If sexually active, subjects must agree to use appropriate contraceptive measures for 
the duration of the study for inclusion. Medically acceptable contraceptives include: (1) surgical sterilization 
(such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, 
patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, 
or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after 
unprotected sex, are not acceptable methods for routine use and will result in exclusion from the study. 
 
4.3 Transcranial Magnetic Stimulation (TMS) administration 
On day 2, the patient would be transported from the inpatient unit to the TMS lab in the red zone on the fifth 
floor following screening and consent process. They would be accompanied by nursing staff. During their visit 
to the TMS lab a sample TMS session including motor threshold determination will be conducted.  
 
Treatment Sessions 
On day 2, subjects would also be administered left sided theta burst stimulation (TBS) with concomitant EEG 
monitoring. The subject will be seated in a chair. A 64-channel electrode cap may be applied to the head for 
EEG recording. EMG electrodes will be applied to the right hand for motor evoked potential (MEP) recording. 
Subjects will perform BACS ebefore and after the TMS session. EEG and EMG will be recorded throughout the 
treatment sessions. For theta burst stimulation the active motor threshold would be 80 % as used in most 
theta burst studies detailed in this review. Subjects would receive theta burst stimulation comprising 50 Hz 
bursts given at 3 to 5 Hz for close to 10 minutes which comprises 60 trains and 1800 pulses. The subject will be 
monitored until MEPs return to baseline. A side effects checklist will be completed at the beginning and at the 
end of the experimental session. All sessions will be performed by one of the protocol investigators, or by a 
trained and accredited research assistant supervised by the protocol investigators.  
 
Methods: 
Motor Threshold Determination:  
Motor threshold (MT) is defined as the TMS pulse amplitude needed to elicit an EMG response of 50 µV peak-
to-peak average amplitude in a target muscle.  MT is the standard in the field for determining the intensity of 
TMS for everyone to reduce seizure risk. The MEP for the right first dorsal interosseus (FDI) will be measured 
with EMG.  The scalp region producing the largest amplitude MEP will be identified.  At that scalp location, we 
will determine the TMS intensity eliciting average MEP amplitude of 50 µV peak-to-peak in the first DI muscle 

 
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using an amplitude titration procedure (at least 5/10 trials).  Individual MT will be used to determine the 
intensity of theta burst stimulation for everyone, as recommended by safety guidelines.  
 
Application of theta burst stimulation (TBS) 
A magnetic coil will be placed on the scalp and held in place with frameless stereotaxic equipment, using a 
sophisticated method of coil placement that will coregister scalp positions directly onto an average brain 
template.  This Frameless Stereotaxic System Brainsight offers real-time three-dimensional display of cortical 
localization as the TMS coil is moved across the scalp. This will be used for coil positioning.  This system uses a 
programmed robot arm to precisely position the TMS coil, and maintain its position, within 1 mm of the brain 
target chosen. Earplugs will be worn to protect hearing and low-volume white noise will be played through 
TMS-compatible headphones to mask the sound of the coil clicks. The intensity of the theta burst stimulation 
will be 80% AMT as reported in a recent review on parameters of theta burst stimulation and a review on 
safety of the theta burst stimulation. The participant will be seated comfortably with headphones and 
earplugs to protect the subject’s hearing. The theta burst stimulation parameters (comprising 50 Hz bursts 
given at 3 to 5 Hz for close to 10 minutes which comprises 60 trains and 1800 pulses) will be kept strictly 
within consensus safety limits: when kept within these limits, is deemed low risk (12).  
 
4.5 Clinical and cognitive assessments/tasks 
PANSS 
The Positive and negative symptoms scale is used to assess the severity of schizophrenia. It has three 
subscales – positive, negative and general psychopathology. Each of these subscales had 7 items, the 
maximum scores on each of these subscales in 49, minimum score being 7. 
 
 
BACS – Tasks to be done from the actual BACS battery of tests (13) 
List Learning (Verbal Memory). Patients are presented with 15 words and then asked to recall as many as 
possible. This procedure is repeated 5 times. There are two alternate forms. 
Digit Sequencing Task (verbal working Memory). Patients are presented with clusters of numbers of increasing 
length. They are asked to tell the experimenter the numbers in order, from lowest to highest. 
Token Motor Task (Motor Speed). Patients are given 100 plastic tokens and asked to place them into a container 
as quickly as possible for 60 seconds. 
Verbal Fluency. Tests of Category Instances (Semantic Fluency) and Controlled Oral Word Association Test 
(Letter Fluency) are administered. Patients are given 60 seconds to name as many words as possible within a 
given semantic category, and in two separate trials, patients are given 60 seconds to generate as many words as 
possible that begin with a given letter. The total number of words from the three trials is the outcome measure. 
Tower of London (Reasoning and Problem Solving). Patients look at two pictures simultaneously. Each picture 
shows 3 different-colored balls arranged on 3 pegs, with the balls in a unique arrangement in each picture. The 
patients are told about the rules in the task and are asked to provide the least number of times the balls in one 
picture would have to be moved to make the arrangement of balls identical to that of the other, opposing 
picture. There are two alternate forms. 
Symbol Coding (Attention and Processing Speed). As quickly as possible, patients write numerals 1–9 as 
matches to symbols on a response sheet for 90 seconds. 
Each of the six measures are compared to a healthy control sample to create z-scores, and a composite score is 
calculated by summing these z-scores and calculating a z-score of that sum. (Keefe et al., 2004b). The 
composite score has high test-retest reliability in patients with schizophrenia and healthy controls (ICCs > .80). 
 

 
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4.7 Timeline of assessments 
Assessments 
B 
(Day 1) 
MT 
(Day 1) 
TMS 
(Day 2) 
Post 
(Day 2) 
Consent 
X 
 
 
 
 
 
 
 
 
PANSS 
X 
 
 
X 
CGI 
X 
X 
 
 
Edinburg 
handedness 
Questionnaire 
X 
 
 
 
BACS 
X 
 
 
X 
 
5. Subject Selection - Inclusion and exclusion criteria 
Inclusion Criteria 
Method of ascertaining 
Inpatients with schizophrenia age group of 18-
50 
Self-report and clinical judgement 
No other DSM diagnoses 
Hospital chart 
Right handed males and females 
Edinburg handedness questionnaire 
May have mild positive symptoms 
Positive symptoms subscale(PANSS) </=21 
May have negative symptoms 
Negative symptoms subscale (PANSS) 
Ability to provide informed consent 
Self-report 
No restriction on concomitant medications 
given 
Hospital chart 
Exclusion criteria 
 
Intellectual disability 
Hospital chart, clinical exam 
Any organic brain illness 
Hospital chart and clinical exam 
Presence of dementia symptoms or traumatic 
brain injury 
Hospital chart and clinical exam 
Primary diagnosis of substance use 
Hospital chart and clinical exam 
Seizure disorder 
Hospital chart and clinical exam 
Actively symptomatic with PANSS positive 
symptom sub-scale >21. 
PANSS administration 
Concurrently receiving ECT 
 
 
6. Subject recruitment and compensation 
We will recruit inpatients from the inpatient unit at Duke Medical Center. Inpatients admitted on Williams’ 
Ward in Duke South (4th floor red zone) will be approached for participation after discussion with their 
primary care team. Capacity to consent will be assessed by a member of the treatment team who is not an 
investigator on this study (such as the inpatient attending psychiatrist, nursing staff). Study team members 
(who are not members of the subject's clinical team) will approach potential subjects after the study is 
introduced to potential subjects first by the primary care team members. For both subjects, recruitment 
would proceed as follows: 1) study team member reviews charts of inpatients deemed eligible for the 

 
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study admitted at Duke Medical Center 2) Discuss with primary care team if the subject is appropriate 3) A 
member of patient's primary care team asks patient if they want to hear about study and 4) With patient 
agreement, study team member discusses study with them. Study team member discussing informed 
consent will fully disclose and explain the risks and benefits of the study procedures, and answer the 
patient’s questions about the study and the material presented in the informed consent form. Alternatives 
to study participation will be discussed, and the voluntary nature of participation in the study will be 
emphasized. This consent discussion will be documented in a consent note placed in the patient’s chart. 
Outpatients who wish to participate in the study will be screened over phone. 
 
Patients would be compensated for their participation in the study. Subjects would be compensated for 
time spent in the study. Rate of compensation would be $10/hour – amounting to a total of $30. 
We do not plan to recruit subjects who are involuntarily committed on the unit. If they do appear as 
potential subjects while screening hospital charts, we will wait until they are converted to voluntary status 
before approaching them for recruitment into the study. Conversion of status from involuntary to 
voluntary occurs once subject’s illness symptoms have improved and are closer towards remission. 
 
7. Consent Process – see Section 14 of the e-IRB submission form 
8. Subject’s Capacity to Give Legally Effective Consent – All patients recruited for this study must have 
capacity to give legally effective consent. For consent, the study would be discussed with patient by study 
personnel and a member of their primary treating team will administer the University of California, San 
Diego Brief Assessment of Capacity to Consent (UBACC) to ascertain validity of the consent given for the 
study. 
 
9. Study Interventions – This has been described in detail in section 4.3 
 
10. Risk/benefit assessment 
There are no known long-term health risks to the use of rTMS per se when operated within consensus 
safety guidelines(14). The Duke Medical Center Institutional Review Board recently classified two similar 
research applications of rTMS proposed by the PI as a “non-significant risk” (Protocols 20218 and 24349). In 
2008, the FDA approved the use of high frequency rTMS in the treatment of depression. Also in 2008, an 
international consensus conference on safety guidelines for rTMS met, including representatives from our 
own labs (Drs. Lisanby and Peterchev). Their report (14) systematically reviewed the thousands of healthy 
subjects and patients who have undergone rTMS in order to allow for a better assessment of relative risks. The 
relative infrequency of adverse events using rTMS was noted. They concluded that in the case of Class 3 
studies (studies involving indirect benefit and low risk in normal subjects and patients that are expected to 
yield important data on brain physiology or safety, but have no immediate relevance to clinical problems), 
normal volunteers should be permitted to participate in rTMS research when it is likely to produce data that 
are of outstanding scientific or clinical value. They also concluded that this research can be performed in a 
non-medical setting (i.e., psychology labs, robotics labs, research institutions, etc. as opposed to a hospital or 
appropriately equipped outpatient clinic). The Rossi et al. consensus report went on to suggest safety 
guidelines based on the now rather extensive international experience with rTMS. These guidelines include 
the rTMS intensity and timing parameters considered safe, training, and planning for and managing 
emergencies. We will follow these guidelines, and have incorporated them into our screening and session 
procedures. 
 

 
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Safety of theta burst stimulation 
The Consensus Statement reached at the Sienna Meeting (14) updated previous guidelines includes 
information about asynchronous trains such as theta burst stimulation (TBS) paradigms including intermittent 
theta burst stimulation that would be the pattern of stimulation used in this study. A review of the safety of 
the procedure done by Oberman et al (2011) showed that the incidence of side effects was 0.5 % (Break down 
comprising headache or other craniofacial pain – 46 %, seizure 2%, muscle contractions 10 %, worsening 
tinnitus 6%, eye lacrimation 2%, lightheadedness 22%, nausea 2% and non-specific discomfort 10 %) (12). The 
reviewed population included 67 studies with a combined total subject number of 1040 people, and involving 
a total number of sessions exceeding 4,500. Of the 1001 subjects 776 were healthy control participants while 
225 were clinical patients with both psychiatric and neurological diagnoses. 97 patients in this review received 
stimulation to the dorsolateral prefrontal cortex.  
This review calculated the crude risk per subject for a seizure from theta burst stimulation to be 0.1 % 
while the crude risk per subject of mild adverse events (encompassing the remainder of the reported events) 
is 5% overall for both patients and healthy controls. As many studies involve multiple sessions of TBS, they 
calculated the crude risk of seizure per session of TBS as approximately 0.02%, and 1.1% for mild adverse 
events. 
This meta-analysis also found that both the reported symptoms and general risk of adverse events 
during TBS is comparable to or less than other high frequency rTMS protocols (14). Seizure, the most severe 
reported adverse event, has only occurred once in over 4,500 sessions resulting in a crude risk of 0.02%, while 
the overall crude risk of any adverse event is estimated as 1.1%. This is comparable with other high frequency 
rTMS protocols where seizures have occurred in less than 0.1% of patients. The most common reported 
adverse event during TBS is also the most common in other rTMS protocols, transient headache and neck pain. 
This adverse event has been reported in up to 40% of patients undergoing high frequency rTMS and was 
experienced by less than 3% of the subjects receiving TBS. Participation is this study is completely voluntary, 
and there will be no pressure or time constraints regarding the decision to participate. There are no benefits 
to the participants except for the compensation, as well as the good will of helping the progress of scientific 
research. The information learned from this study may aid our understanding of the role of the theta burst 
stimulation in modulating cognition and brain function in patients with schizophrenia. 
               
TMS Adverse Events Plan:   
 
Seizure is a theoretical risk with rTMS. In the Rossi et al. report it was stated that “The occurrence of 
seizures has been extremely rare, with most of the few new cases receiving rTMS protocols exceeding 
previous guidelines, often in patients under treatment with drugs which potentially lowered the seizure 
threshold.”  As Rossi et al. delineate, “rare” means that 16 cases (out of tens of thousands of rTMS sessions 
over the last two decades) of seizure related to rTMS have been reported. Eight occurred before safety 
parameters were established in 1997. Of the other eight reports, six occurred either when the safe rTMS 
parameters were exceeded or other safety guidelines ignored, and the actual occurrence of a seizure has been 
questioned in the other two (i.e., convulsive syncope or pseudoseizure may have occurred). In a workshop 
convened by the National Institute for Neurological Disorders and Stroke (NINDS) in 1996 (Duke investigators, 
Dr. Luber, and Dr. Lisanby were participants), researchers in the field agreed upon a set of rTMS consensus 
safety guidelines, including recommended stimulation parameters and contra-indications (15), and these 
consensus guidelines have been recently updated (Rossi et al., 2009). Widespread adherence to the 1996 
guidelines has resulted in the virtual elimination of inadvertent seizures in rTMS studies (Rossi et al., 2009). 
The levels of stimulation used in this protocol are well within safety guidelines (Rossi et al., 2009; Wassermann 
et al. 1998).  

 
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We will screen subjects for known risk factors for seizure with rTMS (medical screening and medical 
history). Personnel who administer rTMS are trained to recognize a potential seizure event and to act as “first 
responders” to administer appropriate initial care. All study personnel have undergone Basic Life Saving 
training, and seizure-specific training. The major physical signs the study personnel will look out for in 
detecting a potential seizure include chewing movements, convulsions/tremor/shaking, difficulty talking, a 
blank stare, eyes rolling up, and profuse sweating. If any of these signs are observed, study personnel will stop 
the research procedure and inquire whether the subject feels okay. If the subject is unresponsive (and 
therefore likely experiencing a seizure), first-aid will be supplied. The first-aid response consists of making sure 
the subject is physically safe for the duration of the seizure. This involves moving the subjects out of the rTMS 
chair and onto the floor lying down on his or her left side. The subject will be kept lying down on his or her left 
side, while the staff call emergency medical help, via a 911 call. Resources available in the laboratory include a 
first-aid kit and immediate phone access. A seizure constitutes a reportable adverse event, and will thus be 
immediately reported to the IRB via the Safety Events Form mechanism. 
The most commonly reported side effect of rTMS is headache. This headache is typically of a muscle-
tension type. It usually develops during or immediately after the stimulation and may last for minutes to hours 
following the end of the stimulation. It is typically limited to the day of stimulation, and usually responds 
promptly to single doses of over the counter pain medications. Neck pain or scalp pain may also occur. Both 
are usually managed easily with over-the-counter analgesics.  
As noted in Rossi et al. (2009), Loo and colleagues reported mild and transient changes in auditory 
threshold in two depressed patients following a 2-4 week rTMS course of rTMS (16). Cases of tinnitus have 
been reported after rTMS treatments. In addition, recently in a study investigating the effects of rTMS on 
symptoms of depression, a patient experienced moderate to severe tinnitus after an rTMS session in which 
earplugs were not used. Rossi et al. recommended that hearing protection always should be worn during rTMS 
application, and that individuals with cochlear implants not receive rTMS. In the current study, earplugs will be 
worn by all subjects during rTMS procedures. Individuals with cochlear implants will be excluded from 
participation. 
Risks to the unborn children of pregnant women receiving rTMS are unknown. Pregnant women will be 
excluded as per IRB policy. If sexually active, the subject must agree to use appropriate contraceptive 
measures for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization 
(such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, 
patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with spermicide, 
or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after 
unprotected sex, are not acceptable methods for routine use. If the subject has any uncertainty about 
whether they could be pregnant, another urine pregnancy test will be performed before they can participate 
in this protocol. The person(s) who will perform the urine pregnancy test will have successfully completed 
training as directed by the Chair of Obstetrics and Gynecology of the Duke University School of Medicine. The 
urine pregnancy test kits used for this research study will be those commercially available test kit specified by 
the Chair of Obstetrics and Gynecology and in routine use at DUHS. 
 
Costs to the Subject – Subjects would not incur any costs because of participation in this research study. There 
would compensation for patients in this study. Subjects would receive standard of care and there are no 
additional visits as part of the study. The study sponsor would pay for the TMS procedure. 
 
 
11. Data Analysis & Statistical Considerations  

 
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The BACS data and EEG data will be analyzed using MATLAB and done by the study coordinator. We will 
perform multiple t tests to see if one session of theta burst stimulation can modulate working memory 
performance and EEG in patients with schizophrenia. This is a pilot study and so we limit recruitment to 10 
patients. 
 
12. Data & Safety Monitoring  
 
Data and safety monitoring will follow standard protocol procedures. Any serious adverse event will be 
reported within 24 hours to the Duke IRB. Adverse events will be documented and addressed accordingly. 
The participants will be fully informed of the nature of the study requirements prior to enrollment and 
periodically throughout the study. The participants’ well-being will be continuously monitored by the 
experimenter, and the Principal Investigator will report all serious adverse events in an expedited manner 
to the Duke University Health System (DUHS) Institutional Review Board (IRB) office and all applicable 
regulatory authorities in accordance with the Center’s standard operating procedures. The study monitor 
will be Dr. Steven Szabo. Dr. Szabo will ensure the quality of the study and establish that all study staff are 
complying with the investigational plan and IRB regulations.  Monitoring of this protocol is simplified by 
the fact that this study involves a small number of investigators and a single facility in which the study is 
being conducted. Throughout the investigation, the monitor will ensure that the facilities being used 
continue to be acceptable for the purposes of the study, that the investigational plan is being followed, 
that any changes to the protocol have received IRB approval and have been reported to the sponsor, that 
accurate, complete, and current records are maintained, that accurate, complete, and timely reports are 
made to the IRB.  This will be accomplished through quarterly meetings during which the status of the 
protocol, investigators, and IRB compliance are reviewed.  The monitor will review each research chart for 
completeness and accuracy. He will confirm that inclusion and exclusion criteria have been met for each 
subject enrolled, and compliance with all other aspects of the investigational plan are met. 
 
13. Privacy, Data Storage & Confidentiality – see Section 12 of the e-IRB submission form and complete the 
questions in that section 
 
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