The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Sponsor: University of British Columbia

    
 
 
 
1 
 
 
 
 
 
 
 
 
 
 
The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy 
in Civilian Post-Traumatic Stress Disorder  
    
Identifiers: 
NCT01806168    
Unique Protocol ID:  
H12-01578    
Secondary IDs:  
V12-01578 
Brief Title: 
rTMS in the Treatment of PTSD 
 
 
Protocol V3.0 
December 10, 2012 
 

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian 
Post-Traumatic Stress Disorder     
rTMS & PTSD Protocol V3.0  
December 10, 2012 
2
Background 
 
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric condition in response to one or more 
traumatic events including interpersonal violence, accidents, disasters or military action. PTSD can 
occur at any age and is characterized by clusters of symptoms of consisting of (a) event re-experience, 
(b) avoidance, and (c) hyper-vigilance (1). In the US, the lifetime prevalence of PTSD in the general 
population is estimated at 7.5% while in Canada it is estimated at 9.2% (2;3). PTSD in civilian (ie: 
non-combat veterans) populations has been associated with higher health care costs in comparison to 
those with Major Depression, and associated with higher costs even when adjusted to depression and 
other comorbidities (4;5). 
 
Pharmacological and psychological modalities for PTSD are intended to ameliorate symptoms and 
improve function. A wide range of treatments have been examined and used clinically to treat PTSD. 
These include antidepressants such as selective serotonin reuptake inhibitors (SSRIs) (6-11), and 
therapies such as Eye Movement Desensitization and Reprocessing, and Trauma Focused Cognitive 
Behavioral Therapy (12-16). A systematic review conducted by the National Institute for Clinical 
Excellence found there was some evidence for psychological treatments in comparison to wait-listed 
controls, and limited evidence for the use of pharmacological treatments compared to placebo in 
patients with PTSD (17). 
 
Repetitive transcranial magnetic stimulation (rTMS) is a well-tolerated and non-invasive treatment that 
utilizes a high powered magnetic field to create electromagnetic energy to depolarize cortical neurons 
up to 3 cm below the surface of the scalp. The treatment is delivered by a magnetic coil placed at the 
surface of the scalp below the target brain area while the patient is fully awake, and no anesthesia is 
required. Depending on the frequency of the stimulation, it can enduringly increase or decrease brain 
activity in specific brain regions resulting in changes in monoamine levels (18;19) and brain 
metabolism (20). Very few adverse events are experienced by patients. The occurrence of a seizure 
during rTMS is extremely rare and only 16 cases have been reported in the literature through decades 
of research and clinical practice worldwide with tens of thousands of patients. The frequency of seizure 
with rTMS is not entirely clear. Nevertheless, it is a rare risk that is always discussed during the 
consent process, and those at elevated risk for seizures (eg: prior history of seizures, on medications or 
substances known to trigger seizures) are screened out. No seizures have ever occurred at our VGH 
rTMS clinic. 
 
Repetitive transcranial magnetic stimulation has been shown to be safe and effective in the treatment 
of major depressive disorder (MDD) (21-41) is now an approved treatment for MDD by Health 
Canada (since 2002) and the U.S. Food and Drug Administration. The parameters of rTMS treatment 
include location (usually targeting the dorsolateral prefrontal cortex [DLPFC]), hemisphere (right or 
left), and intensity. Studies have shown high frequency (>3Hz) rTMS can lead to long-term 
potentiation, and low frequency (1 Hz) rTMS can can lead to long-term inhibition of neurons, both of 
which can be effective in treating MDD through direct and indirect changes (42;43). For depression, 
both high frequency (10-20 Hz) rTMS over the left DLPFC and low frequency (1 Hz) rTMS over the 
right DLPFC have shown efficacy (44).  
 
There is now emerging evidence of efficacy of rTMS in the treatment of other psychiatric disorders 
such as panic disorder and anxiety (45-53). However, the utility of rTMS in the treatment of PTSD has 
not been extensively studied and only a limited number of studies exist with small sample sizes, and 
differing methodologies. PTSD can lead to abnormal changes in brain metabolism in certain cortical 
and subcortical areas. Two of the most frequent positron emission tomography (PET) and functional 

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian 
Post-Traumatic Stress Disorder     
rTMS & PTSD Protocol V3.0  
December 10, 2012 
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magnetic resonance imaging (fMRI) findings suggest decreased activity in the medial prefrontal cortex 
(mPFC) and the anterior cingulate cortex, while increased amygdala activation is commonly seen 
(54;55). These brain regions have reciprocal connections to DLPFC so by altering brain function in 
one accessible (to rTMS) region such as the DLPFC, it can indirectly lead to changes in other regions 
(56). Moreover, studies of those with PTSD have shown greater abnormality in the right hemisphere 
compared to left hemisphere, making the right side a more specific target for brain stimulation (57). 
These changes could theoretically lead to improvement in PTSD symptoms. 
 
Preliminary uncontrolled studies suggest that rTMS has an effect on PTSD symptoms. Grisaru and 
colleagues treated 10 patients with bilateral rTMS using 0.3 Hz for 30 stimuli in a single session (58) 
while McCann et al. treated two patients for 10 sessions of 20 Hz rTMS over the left DLPFC (59). 
Both studies showed improvement in core PTSD symptoms, but the effects were transient. Rosenberg 
examined the effects of rTMS with left DLPFC at 1 Hz or 5 Hz in 12 patients with comorbid PTSD 
and MDD (60), and found large effects on depressive symptoms and smaller, but statistically 
significant, improvement in PTSD symptoms.  
 
The results of randomized controlled trials (RCTs) of rTMS for PTSD have also been promising. In a 
double-blind, sham-controlled RCT, Cohen et al. examined the efficacy of 14 days of rTMS over the 
right DLPFC, comparing low frequency (1 Hz) to high frequency (10 Hz) in 24 patients with PTSD 
(61). Results indicated significant improvement in core PTSD symptoms for patients in the 10 Hz 
treatment group compared to sham, but not the 1 Hz group. Boggio et al. conducted a double-blind, 
sham-controlled RCT in 30 patients diagnosed with PTSD (62). Patients were randomized to either 
sham or high frequency (20 Hz) rTMS for two weeks, over right or left DLPFC. Results showed that 
both right and left 20 Hz rTMS significantly reduced PTSD symptoms, but the effect was slightly 
larger on the left side. The reduction in PTSD symptoms was still present at 3-month post-treatment 
follow-up. Only one study by Osuch et al. examined the effects of rTMS in combination with 
psychotherapy (63). In a sham-controlled, cross-over study design, 9 patients were randomized to low 
frequency (1 Hz) or sham rTMS to the right DLPFC rTMS in conjunction with imaginal exposure 
therapy. Results showed no effect for 1 Hz rTMS compared to sham, but the small sample size likely 
led to a Type II error. Finally, Watts et al. conducted the most recent sham-controlled RCT of 20 
patients with PTSD randomized to sham or right DLPFC low frequency 1 Hz rTMS over 10 sessions, 
and found significant improvement in PTSD and depressive symptom scores in the active group over 
the sham, and this change sustained up to 2 months post-rTMS (64). 
 
The results of these studies suggest that rTMS targeting the right DLPFC can ameliorate symptoms of 
PTSD, but there are discrepant results about the efficacy of low frequency (1 Hz) vs. high frequency 
(10-20 Hz). Subjects tolerated the procedure well with no cognitive dysfunction and low dropout rates. 
Furthermore, the utility of rTMS in conjunction with other therapies such as psychotherapy is unclear, 
given the one small study to date. 
 
The rTMS program at Vancouver General Hospital (VGH) currently focuses on the treatment of 
patients with depression. Patients typically receive 20-30 treatment sessions over a 4-6 week period. 
Sessions are conducted on consecutive days, five days a week, by a rTMS-clinic registered nurse under 
the supervision of a psychiatrist trained in rTMS. Each session lasts approximately 30 to 40 minutes. 
The clinic is currently situated right within Centennial Pavilion with ready access to emergency 
response teams and equipment in the unlikely event of a serious adverse reaction occurring during the 
treatment. The clinic is slated to move to Willow Pavilion in July 2012, which also has ready access to 
emergency response. 
 

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian 
Post-Traumatic Stress Disorder     
rTMS & PTSD Protocol V3.0  
December 10, 2012 
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The Outpatient Psychiatry Program (OPP) PTSD program at the VGH Health Centre consists of a two-
phase, 18 week psycho-educational and behavioural skills program developed from the work of Ogden, 
Harris, and Najavits aimed at reducing symptoms of PTSD (65-67). Phase One is eight weeks long and 
includes psychoeducation about psychological trauma. Phase Two is 10 weeks long, and is designed to 
address longer term or complex traumatic stress disorders. The second phase is based on two models: 
Trauma, Recovery, and Empowerment (TREM) and Seeking Safety (66;67). Patients are referred from 
community care providers and are expected to complete the 18 week program if accepted. These 
patients are not combat veterans since there is already another existing resource for treating those 
patients elsewhere. Preliminary data from our clinic indicate that those patients completing Phase 1 of 
our program have very little improvement in their PTSD symptom scores, but Phase 2 can have a 
greater impact.  
 
The presence of both programs at one site provides a unique opportunity to examine both the short and 
longer-term effects of rTMS as stand-alone treatment and in combination with psychotherapy. There is 
a break of 3-4 weeks between Phase 1 ending and Phase 2 beginning, so this period of time allows for 
rTMS to be conducted for patients willing to undergo this treatment.  
 
In Canada, there are no restrictions for the range of mental disorders that rTMS can be used for in 
treating patients, although MDD is the condition that is the most commonly treated. Based on reports 
in the literature, we anticipate that right sided rTMS is as safe and tolerable as left-sided rTMS. 
Therefore, we propose to conduct a study of rTMS in patients with PTSD who are starting the group 
psychotherapy program at VGH. Since previous research has shown a discrepancy between the 
efficacy of high versus low frequency rTMS on the symptoms of PTSD, we will examine the use of 
high (10 Hz) versus low (1 Hz) frequency rTMS delivered over the right DLFPC of patients suffering 
with PTSD symptoms unrelated to combat. Standardized evaluations will be done to assess for clinical 
improvements in the PTSD, depressive and anxiety symptom clusters, and for tolerability with 
monitoring of adverse events and dropout rates. 
 
Primary Hypothesis 
The primary hypothesis is that high frequency (10 Hz) rTMS over the right DLPFC will be superior to 
low frequency (1 Hz) in reducing scores as measured by the PTSD Check List.  
Research Method 
Subject Recruitment 
Subjects will be recruited from the PTSD treatment program conducted at the VGH Outpatient 
Psychiatry Program (OPP). Mid-way during the Phase 1 of the group psychoeducational program, 
patients will be approached regarding their willingness to participate in the study. Those subjects 
expressing interest will receive a description of the study along with an informed consent form that the 
client can sign if s/he chooses to participate. Should the patient agree to participate, a screening 
interview will be administered to determine if s/he meets the inclusion / exclusion criteria. 
 
Inclusion criteria: (1) primary diagnosis of PTSD as determined by a structured interview (Mini 
International Neuropsychiatric Interview, MINI (68)); (2) no change in psychotropic medications 
within 4 weeks before the start of rTMS; (3) age greater than 19 years and less than 70 years; and (4) 
competent to give informed consent. 
 

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian 
Post-Traumatic Stress Disorder     
rTMS & PTSD Protocol V3.0  
December 10, 2012 
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Exclusion criteria: (1) any non-fixed metal object or implant (including cochlear implants) in brain, 
skull, scalp, or neck within 30 cm of the magnetic rTMS coil; (2) implantable devices, including 
cardiac pacemakers and defibrillators; (3) other contraindications to rTMS, including history of 
seizures (except childhood febrile seizures) or recurrent and unexplained syncope, first degree relative 
with a history of epilepsy, treatment with a medication known to substantially decrease the seizure 
threshold, and pregnancy; (4) psychiatric diagnoses of psychosis or psychotic disorder (including 
psychotic depression), bipolar type 1 disorder, organic mental disorders; (5) substance 
abuse/dependence within the past 3 months;  (6) active suicidal risk as judged by the clinician; (7) 
borderline or antisocial personality disorder; (8) acute medical illness, including cancer; (9) any 
significant central nervous system disorder such as brain mass, stroke.  
 
Research Design 
This will be a prospective, 2-week, double-blind (subject and evaluator) randomized controlled pilot 
study to assess the effect of repetitive transcranial magnetic stimulation (rTMS) in patients with a 
confirmed diagnosis of PTSD. The rTMS will target the right DLPFC. Subjects will be randomized 
into either 1 Hz or 10 Hz treatment arms, or sham arm.. The rTMS will be administered between Phase 
1 and 2 of the PTSD OPP, so there will not be concurrent group therapy during the 2-week rTMS 
sessions. Outcome measures will be assessed at baseline, after 1 week and 2 weeks (completion) of 
rTMS, and at follow up after Phase 2 of the PTSD OPP group psychotherapy program (approximately 
10 weeks after completion of rTMS).  
 
Primary Outcomes 
o Changes in PTSD symptoms as measured by – Clinician Administered PTSD Scale 
(CAPS (69)), patient rated Post Traumatic Stress Disorder Checklist Civilian (PCL-C). 
 
Secondary Outcomes 
• 
Changes in symptoms as assessed by: 
o For Depression – clinician administered Hamilton Depression Rating Scale (17 items) 
(HAMD), patient rated Quick Inventory of Depressive Symptomatology-Self-report 
(QIDS-SR (70)). 
o For Anxiety – Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder 
Assessment (GAD-7). 
o These are all standardized, validated symptom measures that are widely used in clinical 
and research settings. The QIDS-SR, GAD-7 and PCL-C are also used as routine 
clinical outcome measures in the PTSD OPP.  
• 
Adverse events, safety, and tolerability 
o Incidence of serious and non-serious adverse events attributable to rTMS (eg: headache, 
scalp pain, facial pain, dizziness, tinnitus, light-headedness, syncope, seizure).  
o Montreal Cognitive Assessment (MOCA). 
 
Procedures and Methods 
After giving written, informed consent, subjects will undergo baseline assessment measures. Eligible 
subjects will be randomized to one of three treatment arms (high or low frequency rTMS, or sham 
rTMS). Concealment of allocation will be accomplished using a computerized randomization program 
that reveals treatment allocation only after the unique subject identifier is entered. The randomization 
codes will be available on a 24-hour basis in the (unlikely) event that the blind needs to be broken for 
clinical reasons. The subject will be blind to treatment condition because they will be unaware of the 
rTMS frequencies or sham condition used in the study. The rTMS nurse will be unblinded, but the 

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian 
Post-Traumatic Stress Disorder     
rTMS & PTSD Protocol V3.0  
December 10, 2012 
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evaluator for clinician-rated assessments will be blind to treatment conditions. The rTMS nurse will 
not interact with the evaluator, and should any unblinding occur, the evaluator will be replaced.  
 
The secondary outcome measures will be repeated weekly after rTMS session number 5 and 10 (or at 
termination, for early withdrawals). Adverse events and severity (mild, moderate, severe) will be 
recorded at each session. Serious adverse events will be defined according to standard Health Canada 
definitions as those which: a) result in death; b) are life threatening; c) are severely or permanently 
disabling; d) require inpatient hospitalization; e) result in an incidence of cancer; f) result in a drug 
overdose or reaction after drug withdrawal. All subjects who withdraw from the study will be asked to 
state a reason for withdrawal. The outcome measures will also be repeated after completion of the 
Phase 2 group psychotherapy program (about 10 weeks following completion of the rTMS).  
 
The blind evaluator(s) will receive standardized training to establish inter-rater reliability using 
videotaped interviews. Reliability of outcome assessment will also be enhanced by using structured 
inteview guides for the HAMD and CAPS. 
 
Interventions (rTMS Stimulation) 
The motor threshold is determined during the first session by applying TMS over the motor cortex in 
order to get the minimal level of stimulus intensity from the device which will create a contraction in 
the contralateral abductor pollicis brevis muscle of the thumb. The DLPFC will be targeted by 
measuring 6 cm anterior to this motor cortex landmark, along the sagittal plane, as the patient will be 
wearing a swimmer’s cap. The intensity of the stimulus is set by going 100-120% of the intensity 
which determined motor threshold. rTMS therapy over the right DLPFC will be given on 5 consecutive 
days every week for two weeks for a total of 10 therapy sessions using a Magstim Super Rapid2 
(Magstim Company Ltd., Carmarthenshire, Wales, UK) with a Rapid-2 Air Film Coil.  
 
Subjects will receive either active rTMS to the right side at 1 Hz or at 10 Hz, or sham treatment for 
37.5 minutes per session. The stimulus parameters that will be chosen for treating subjects will be 
similar to the parameters currently used at our clinic to stimulate patients with depression. A clinic 
nurse will always be present to deliver the treatment, and a supervising rTMS psychiatrist will oversee 
the appropriate placement and intensity of the coil, as well as responding to any adverse event which 
may arise. Each subject is given appropriate ear protection due to the intensity of the sound from each 
treatment pulse delivered by the device. Subjects who experience some initial discomfort during the 
session, such scalp or facial irritation, will prompt trying a different orientation of the coil at the same 
DLPFC site, which will usually relieve the discomfort. Subjects may leave immediately on their own 
after the treatment is completed, and may even drive, unless a serious adverse event occurred. 
 
SAMPLE SIZE 
Based on the standardized effect size for the primary outcome, the PTSD Check List, as determined by 
the previous RCT (71;72) (d=1.4), and with alpha set to 0.05 and 80% power, we estimated a sample size 
of nine subjects/condition. Note that this effect size is regarded as a large effect and is clinically 
significant.  
 
Data Analysis 
All randomized subjects will be included in the analysis based on intent-to-treat. Missing data will be 
imputed using last observation carried forward (LOCF). The pre-specified primary efficacy endpoint is 
the adjusted mean change from baseline to endpoint (2 weeks) on the PTSD Check List using LOCF. 
All comparisons will be analyzed using ANCOVA adjusting for baseline value. The secondary 
outcomes will also be analyzed using a similar analysis, when appropriate. Post hoc analyses will also 

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian 
Post-Traumatic Stress Disorder     
rTMS & PTSD Protocol V3.0  
December 10, 2012 
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examine observed case data. Categorical data (such as proportions of the sample with adverse events) 
will be analyzed using chi-square tests or Fisher's test where cell sizes warrant.  
 
 

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian 
Post-Traumatic Stress Disorder     
rTMS & PTSD Protocol V3.0  
December 10, 2012 
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 (45)  George MS, Lisanby SH, Sackeim HA. Transcranial magnetic stimulation: applications in 
neuropsychiatry. Arch Gen Psychiatry 1999 Apr;56(4):300-11. 
 (46)  Bloch Y, Grisaru N, Harel EV, Beitler G, Faivel N, Ratzoni G, et al. Repetitive transcranial 
magnetic stimulation in the treatment of depression in adolescents: an open-label study. J ECT 
2008 Jun;24(2):156-9. 
 (47)  Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive 
Transcranial Magnetic Stimulation (rTMS) in the treatment of panic disorder (PD) with 
comorbid major depression. J Affect Disord 2007 Sep;102(1-3):277-80. 
 (48)  Paes F, Machado S, rias-Carrion O, Velasques B, Teixeira S, Budde H, et al. The value of 
repetitive transcranial magnetic stimulation (rTMS) for the treatment of anxiety disorders: an 
integrative review. CNS Neurol Disord Drug Targets 2011 Aug 1;10(5):610-20. 
 (49)  Pallanti S, Bernardi S. Neurobiology of repeated transcranial magnetic stimulation in the 
treatment of anxiety: a critical review. Int Clin Psychopharmacol 2009 Jul;24(4):163-73. 
 (50)  Pigot M, Loo C, Sachdev P. Repetitive transcranial magnetic stimulation as treatment for 
anxiety disorders. Expert Rev Neurother 2008 Oct;8(10):1449-55. 
 (51)  Sakkas P, Psarros C, Papadimitriou GN, Theleritis CG, Soldatos CR. Repetitive transcranial 
magnetic stimulation (rTMS) in a patient suffering from comorbid depression and panic 
disorder following a myocardial infarction. Prog Neuropsychopharmacol Biol Psychiatry 2006 
Jul;30(5):960-2. 

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rTMS & PTSD Protocol V3.0  
December 10, 2012 
12
 (52)  Sarkhel S, Sinha VK, Praharaj SK. Adjunctive high-frequency right prefrontal repetitive 
transcranial magnetic stimulation (rTMS) was not effective in obsessive-compulsive disorder 
but improved secondary depression. J Anxiety Disord 2010 Jun;24(5):535-9. 
 (53)  Zwanzger P, Eser D, Volkel N, Baghai TC, Moller HJ, Rupprecht R, et al. Effects of repetitive 
transcranial magnetic stimulation (rTMS) on panic attacks induced by cholecystokinin-
tetrapeptide (CCK-4). Int J Neuropsychopharmacol 2007 Apr;10(2):285-9. 
 (54)  Bremmer MA, Deeg DJ, Beekman AT, Penninx BW, Lips P, Hoogendijk WJ. Major 
depression in late life is associated with both hypo- and hypercortisolemia. Biol Psychiatry 
2007 Sep 1;62(5):479-86. 
 (55)  Francati V, Vermetten E, Bremner JD. Functional neuroimaging studies in posttraumatic stress 
disorder: review of current methods and findings. Depress Anxiety 2007;24(3):202-18. 
 (56)  Kito S, Hasegawa T, Koga Y. Cerebral blood flow in the ventromedial prefrontal cortex 
correlates with treatment response to low-frequency right prefrontal repetitive transcranial 
magnetic stimulation in the treatment of depression. Psychiatry Clin Neurosci 2012 
Mar;66(2):138-45. 
 (57)  Rossi S, De CA, Tavanti M, Calossi S, Polizzotto NR, Mantovani A, et al. Dysfunctions of 
cortical excitability in drug-naive posttraumatic stress disorder patients. Biol Psychiatry 2009 
Jul 1;66(1):54-61. 
 (58)  Grisaru N, Amir M, Cohen H, Kaplan Z. Effect of transcranial magnetic stimulation in 
posttraumatic stress disorder: a preliminary study. Biol Psychiatry 1998 Jul 1;44(1):52-5. 
 (59)  McCann UD, Kimbrell TA, Morgan CM, Anderson T, Geraci M, Benson BE, et al. Repetitive 
transcranial magnetic stimulation for posttraumatic stress disorder. Arch Gen Psychiatry 1998 
Mar;55(3):276-9. 
 (60)  Rosenberg PB, Mehndiratta RB, Mehndiratta YP, Wamer A, Rosse RB, Balish M. Repetitive 
transcranial magnetic stimulation treatment of comorbid posttraumatic stress disorder and 
major depression. J Neuropsychiatry Clin Neurosci 2002;14(3):270-6. 
 (61)  Cohen H, Kaplan Z, Kotler M, Kouperman I, Moisa R, Grisaru N. Repetitive transcranial 
magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: 
a double-blind, placebo-controlled study. Am J Psychiatry 2004 Mar;161(3):515-24. 
 (62)  Boggio PS, Rocha M, Oliveira MO, Fecteau S, Cohen RB, Campanha C, et al. Noninvasive 
brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic 
stimulation treatment for posttraumatic stress disorder. J Clin Psychiatry 2010 Aug;71(8):992-9. 
 (63)  Osuch EA, Benson BE, Luckenbaugh DA, Geraci M, Post RM, McCann U. Repetitive TMS 
combined with exposure therapy for PTSD: a preliminary study. J Anxiety Disord 2009 
Jan;23(1):54-9. 
 (64)  Watts BV, Landon B, Groft A, Young-Xu Y. A sham controlled study of repetitive transcranial 
magnetic stimulation for posttraumatic stress disorder. Brain Stimul 2012 Jan;5(1):38-43. 

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rTMS & PTSD Protocol V3.0  
December 10, 2012 
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 (65)  Ogden P, Minton K, Pain C. Trauma and the body: A sensorimotor approach to psychotherapy. 
New York: W.W. Norton & Company; 2006. 
 (66)  Harris M. Trauma, recovery, and empowerment: A clinician's guide to working with women in 
groups. New York: Free Press; 1998. 
 (67)  Najavits M. Seeking safety: A treatment manual for PTSD and substance abuse. New York: 
Guildford Press; 2002. 
 (68)  Sheehan D, Lecrubier Y, Sheehan Keal. The Mini-International Neuropsychiatric Interview 
(M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for 
DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl 20):22-33. 
 (69)  Blake D, Weathers F, Nagy L. A clinical rating scale for assessing current and lifetime PTSD: 
the CAPS-1. Behavior Therapist 1990;18:187-8. 
 (70)  Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, et al. The 16-Item 
Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-
report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol 
Psychiatry 2003 Sep 1;54(5):573-83. 
 (71)  Cohen H, Kaplan Z, Kotler M, Kouperman I, Moisa R, Grisaru N. Repetitive transcranial 
magnetic stimulation of the right dorsolateral prefrontal cortex in posttraumatic stress disorder: 
a double-blind, placebo-controlled study. Am J Psychiatry 2004 Mar;161(3):515-24. 
 (72)  Boggio PS, Rocha M, Oliveira MO, Fecteau S, Cohen RB, Campanha C, et al. Noninvasive 
brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic 
stimulation treatment for posttraumatic stress disorder. J Clin Psychiatry 2010 Aug;71(8):992-9. 
 
 

rTMS Adult Study Subject Information & Consent Form  
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Version 4.0: December 10,, 2012 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct 
Therapy in Civilian Post-Traumatic Stress Disorder  
    
Identifiers: 
NCT01806168    
Unique Protocol ID:  
H12-01578    
Secondary IDs:  
V12-01578 
Brief Title: 
rTMS in the Treatment of PTSD 
 
 
Information & Consent Form V4.0 
December 10, 2012 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

rTMS Adult Study Subject Information & Consent Form  
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SUBJECT INFORMATION AND CONSENT FORM 
 
 
The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct 
Therapy in Civilian Post-Traumatic Stress Disorder       
Principal Investigator:  
Larry Ong, MD, FRCPC, 604-875-4794  
Co-Investigators:  
     
Raymond Lam, MD, FRCPC; Peter Chan, MD, FRCPC; Hiram Mok, MD, FRCPC; Michael 
Wilkins-Ho, MD, FRCPC; Richard Singleton, MSW; Calla Finley, MSW; Gary Alward, MSW; 
Mario McKenna, MHA, MSC 
 
Sponsor: Vancouver Coastal Health Research Institute  
 
Emergency contact:  604-875-4111 Ext 67732 or 604-875-4794  
 
You are being invited to take part in a pilot study because you have had a diagnosis of post 
traumatic stress disorder (PTSD). A pilot study is a small preliminary study conducted before 
starting a large research study in order to check the feasibility or to improve the design of the 
research. The purpose of this pilot study is to assess the effectiveness of Repetitive Transcranial 
Magnetic Stimulation (rTMS) in subjects with symptoms of PTSD. Your participation is entirely 
voluntary, so it is up to you to decide whether or not to take part in this study. However, it is 
important for you to understand what the research involves before you decide to participate in 
the study. This consent form provides detailed information about the study, why the research is 
being done, what will happen to you during the study and the possible benefits, risks and 
discomforts.   
 
If you wish to participate, you will be asked to sign this form. If you do decide to take part in this 
study you are still free to withdraw at any time and without giving any reasons for your decision. 
If you do not wish to participate, you do not have to provide any reason for your decision not to 
participate nor will you be penalized or lose the benefit of any medical care to which you are 
entitled or are presently receiving. Please take time to read the following information carefully 
and discuss it with your family, friends and doctor before you decide.  
 
WHO IS CONDUCTING THE STUDY? 
Drs. Larry Ong and Raymond Lam have received a research grant from Vancouver Coastal 
Health Research Institute to conduct this study. Drs. Ong and Lam are the principal investigators 
and the Head of the Department of Psychiatry is fully aware of funds they have received to 
conduct this study. As a subject in this study you are entitled to know the details of these 
arrangements and, on request, you will be provided them in writing. Should you have any 
concerns about these disclosures you may contact the office of the Head of the Department of 
Psychiatry at 604-822-7310.  
 

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BACKGROUND  
There are several different methods for treating PTSD including psycho-therapy, counseling, and 
medication. A treatment that has been used successfully to treat depression is Repetitive 
Transcranial Magnetic Stimulation (rTMS). rTMS has also been approved by Health Canada for 
the treatment of symptoms of PTSD but there are only a limited number of studies that have 
looked at this. rTMS uses a high powered magnetic field to stimulate brain cells below the scalp. 
The treatment is delivered using a magnetic coil placed at the surface of the scalp below the area 
of the brain that is to be treated. No anesthesia is required and the subject is completely awake 
during the treatment. rTMS treatment has been available as a treatment in Canada since 2002. 
For the treatment of PTSD, research suggests that stimulating the dorsolateral prefrontal cortex 
(DLPFC) between 1 to 20 Hz. may show improvement in PTSD symptoms.  
  
WHAT IS THE PURPOSE OF THE STUDY 
The main purpose of this study is to examine the effects of rTMS on symptoms of PTSD using 
two different frequencies of stimulation, 1 Hz and 10 Hz versus a sham rTMS. 
 WHO CAN PARTICIPATE IN THE STUDY? 
To be included in this study you must meet the following criteria: 
 
(1) Have a primary diagnosis of PTSD  
(2) No change in psychiatric medications within 4 weeks before the start of rTMS 
(3) Age greater than 19 years and less than 70 years 
(4) Competent to give informed consent. 
 
WHO SHOULD NOT PARTICIPATE IN THE STUDY? 
If you have any of the following you should not participate in this study: 
 
(1) Any non-fixed metal object or implant (including cochlear implants) in brain, skull, 
scalp, or neck within 30 cm of the magnetic rTMS coil 
(2) Implantable devices, including cardiac pacemakers and defibrillators 
(3) Psychiatric 
diagnoses 
of 
psychosis 
or 
psychotic 
disorder 
(including 
psychotic 
depression), bipolar type 1 disorder, organic mental disorders 
(4) Substance abuse/dependence within the past 3 months 
(5) Active suicidal risk as judged by the clinician 
(6) Borderline or antisocial personality disorder 
(7) Acute medical illness, including cancer 
(8) Any significant central nervous system disorder such as brain mass, stroke 
(9) Other reasons that make rTMS not advisable, including history of seizures (except 
childhood febrile seizures) or recurrent and unexplained fainting, first degree relative 
with a history of epilepsy, treatment with a medication known to substantially decrease 
the seizure threshold, and pregnancy 
 
You must be withdrawn from the study if: 
 
(1) You withdraw consent to participate 

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(2) You are no longer able to comply with the study visit schedule 
(3) In the investigators’ judgements (for safety or other reasons) it is in the subject’s best 
interest to be withdrawn 
 
WHAT DOES THE STUDY INVOLVE? 
The study is being carried out at Vancouver General Hospital. Approximately 27 people like you 
will take part in the study.  
1. Overview of the Study – Testing Required for Eligibility  
To make sure that you are suitable for participation in the study you will have a brief visit with a 
study physician that will include: 
 
(1) Medical History (your past and present diseases, medical conditions, medicines 
(prescription and non-prescription) 
(2) Interview to assess your PTSD symptoms in addition to completing some 
questionnaires 
  
2. The Research Intervention 
This research study is being done to test two frequencies of rTMS (1 Hz and 10 Hz) and sham 
rTMS on symptoms of PTSD. Sham rTMS uses a similar magnetic coil like that used in regular 
rTMS, but the sham magnetic coil has a metal insert that blocks the magnetic field. You will be 
randomly assigned (i.e. like the flip of a coin) to receive rTMS treatment at 1 Hz or 10 Hz, or the 
sham rTMS treatment. Whether you are receive the 1 Hz or 10 Hz treatment or sham rTMS 
treatment will be decided by chance (like tossing a coin). rTMS is currently not used to PTSD 
symptoms, and has not been systematically evaluated in a large sample of adults. 
3. Overall Duration of the Study 
The study involves 11 visits over a 2 week period and a final follow up visit at 3 months. Visit 1 
will last approximately 90 minutes, the other visits will last about 60 minutes for a total time 
commitment of roughly 12.5 hours. Each rTMS (1 Hz, 10 Hz, or sham) treatment lasts 37.5 
minutes. At each visit a study physician or nurse ask you about all medications you are taking, 
and your general health. During other visits you will be asked about your PTSD symptoms as 
well as complete some questionnaires before rTMS treatment. This part of the visit might be a 
little different from normal therapy.  
 
4. Study Questionnaires  
The study includes seven questionnaires. At three of rTMS treatment visits, you will be asked to 
complete three questionnaires by yourself. The study physician will complete the other four 
questionnaires that will involve asking some questions about your PTSD as well as other 
symptoms. You do not have to answer any questions you do not feel comfortable with. 
 
IF YOU DECIDE TO JOIN THIS STUDY: SPECIFIC PROCEDURES 
If you agree to take part in this study, the procedures and visits you can expect will include the 
following: 
Visit 1 (Screening) 
1. Determine if your meet the inclusion and exclusion criteria for the study. 

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2. Psychiatric, medical history, reasons to exclude rTMS treatment and other assessments 
by the study physician. 
Visit 2 (Baseline) 
1. Start rTMS treatment at 1 Hz, 10 Hz or sham.  
2. Check for side effects by the study physician. 
3. Complete seven questionnaires (4 by the study physician and 3 by the subject). 
Visits 3 to 5 
1. Check for side effects by the study physician. 
2. Continue rTMS treatment at 1 Hz, 10 Hz or sham. 
Visit 6 
1. Check for side effects by the study physician. 
2. Continue rTMS treatment at 1 Hz,10 Hz or sham.  
3. Complete seven questionnaires (4 by the study physician and 3 by the subject). 
Visits 7 to 10 
1. Check for side effects by the study physician. 
2. Continue on rTMS treatment at 1 Hz,10 Hz or sham. 
Visit 11 (Completion) 
1. Check for side effects by the study physician. 
2. Continue rTMS treatment at 1 Hz,10 Hz or sham.  
3. Complete seven questionnaires (4 by the study physician and 3 by the subject). 
Visit 12 (3 month follow up)  
1. Complete seven questionnaires (4 by the study physician and 3 by the subject). 
 
WHAT ARE MY RESPONSIBILITIES? 
You must be willing to follow the study psychiatrist’s instructions, and go through all the related 
procedures described above. You will have to see the study physician on the scheduled visits. It 
is important that you tell the study physician or nurse about any other medication or treatments 
you are taking before and during the study. 
 
In addition, you will receive sham rTMS treatment or at 1 Hz or 10 Hz. The treatments are 
identical and both the investigators and you will not know which you are receiving at any stage 
of the study. You understand that whether you receive sham treatment or treatment at 1 Hz or 10 
Hz will be decided by chance (like tossing a coin). 
WHAT ARE THE POSSIBLE HARMS AND SIDE EFFECTS OF PARTICIPATING? 
According to published studies of rTMS to date, 1 in 20 patients have experienced common side-
effects, and 1 in 30,000 have experienced serious side-effects. You may experience none, some 
or all of the side-effects listed below. However, there have been no reports of lasting 
consequences. 
Common side effects (less than5%):  
1) Headache 
2) Twitches in the face muscle (during rTMS stimulation) 
3) Effects on mood 
4) Effects on cognition (Note: rTMS does not affect memory and orientation) 

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5) Temporary changes in hormones 
6) Transient hearing loss 
Serious side effects (less than0.00003%) 
(1) Seizure during the application of the rTMS stimulation  
rTMS treatment should also not be used by women who are pregnant.  
During rTMS treatment you will be fitted with a swimmer's cap, and ear protection due to the 
intensity of the sound from each treatment pulse delivered by the device, You may experience 
some initial discomfort during the session such as scalp or facial irritation, If so the treating 
physician will try a different orientation of the coil at the same site which usually eliminates the 
discomfort. 
WHAT ARE THE BENEFITS OF PARTICIPATING IN THIS STUDY? 
If you agree to participate in this study there may or may not be a direct medical benefit to you. 
Your PTSD symptoms may be improved during the study but there is no guarantee that this 
research will help you. The information we get from this study may help us to provide better 
treatments in the future for patients with PTSD.  
You understand that the foreseeable benefits of the study are as follows: The study may decrease 
or eliminate your PTSD symptoms. You will receive a thorough assessment of your health status 
during the study. However, you understand that it is possible that you may not receive any 
benefit from this study and that no guarantees have been made to you. You understand that your 
PTSD symptoms may not be controlled by the treatments used in this study or may even worsen. 
You also understand that as a result of being in this study, you have a random chance of receiving 
sham rTMS treatment or treatment at 1 Hz or 10 Hz. 
WHAT ARE THE ALTERNATIVES TO THE STUDY TREATMENT 
If you choose not to participate in this study, you will be provided with the standard treatments 
that are available for PTSD. You can discuss your options with your psychiatrist before deciding 
whether or not to participate in this research project. 
 
WHAT IF NEW INFORMATION BECOMES AVAILABLE THAT MAY AFFECT MY 
DECISION TO PARTICIPATE? 
If any new information on the study treatment (rTMS) becomes available which may influence 
your decision to continue in the study you will be told. If a more effective treatment becomes 
available it will be offered to you. 
 
WHAT HAPPENS IF I DECIDE TO WITHDRAW MY CONSENT TO PARTICIPATE? 
Your participation in this research is entirely voluntary. You can stop participating in the study at 
any time, and you do not have to give any reasons why you are stopping. If you do not want to 
continue with study treatment or decide to stop for other reasons, you should always speak to the 
study physician on how and when to stop taking the treatment, as this may affect the symptoms 

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of your condition. If you decide to stop your participation, you will be asked to come in for a 
final visit and examination, which will include a brief assessment. If you decide to enter the 
study you may stop at any time in the future, there will be no penalty or loss of benefits to which 
you are otherwise entitled, and your future medical care will not be affected. If you choose to 
enter the study and then decide to withdraw at a later time, all data collected about you during 
your enrolment in the study will be retained for analysis.  
 
WHAT IF SOMETHING GOES WRONG? 
Signing this consent form in no way limits your legal rights against the sponsor, investigators, or 
anyone else, and you do not release the study doctors or participating institutions from their legal 
and professional responsibilities.  
 
By signing this form, you do not give up any of your legal rights and you do not release the study 
doctor or other participating institutions from their legal and professional duties.  There will be 
no costs to you for participation in this study.  You will not be charged for any research 
procedures.  If you become ill or physically injured as a result of participation in this study, 
medical treatment will be provided at no additional cost to you.  The costs of your medical 
treatment will be paid by your provincial medical plan. 
 
 

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CAN I BE ASKED TO LEAVE THE STUDY? 
If you are not complying with requirements of the study or for any other reason, the study 
physician may withdraw you from the study and will arrange for your care to continue. On 
receiving new information about the treatment, the study physician might consider it to be in 
your best interests to withdraw you from the study without your consent if they judge that it 
would be better for your health. Other reasons for stopping your continuation in the study can be 
that a regulatory agency, such as Health Canada, stops the study.  
 
AFTER THE STUDY IS FINISHED 
You may not be able to receive the study treatment after your participation in the study is 
completed. There are several possible reasons for this, some of which include: The treatment 
may or may not turn out to be effective or safe. You may not feel it is the best option for you. 
You may decide it is too expensive and insurance coverage may not be available.  
 
WHAT WILL THE STUDY COST ME? 
You will not be paid for taking part in this study. If you need to take time off from work or other 
activities, this time or loss of wages will not be reimbursed. However, the study treatment, study 
visits and examinations will be provided at no cost to you during the study. Your expenses in 
connection with this study, such as travel and parking, will be reimbursed up to $14.00 per visit 
at each visit with the presentation of receipts.  
 
WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL? 
Your confidentiality will be respected.  However, research records and health or other source 
records identifying you may be inspected in the presence of the Investigator or his or her 
designate by Health Canada, University of British Columbia Research Ethics, or Vancouver 
Coastal Health Research Institute for the purpose of monitoring the research. No information or 
records that disclose your identity will be published without your consent, nor will any 
information or records that disclose your identity be removed or released without your consent 
unless required by law.    
 
 
You will be assigned a unique study number as a subject in this study.  Only this number will be 
used on any research-related information collected about you during the course of this study, so 
that your identity [i.e. your name or any other information that could identify you] as a subject in 
this study will be kept confidential.   Information that contains your identity will remain only 
with the Principal Investigator and/or designate.  The list that matches your name to the unique 
study number that is used on your research-related information will not be removed or released 
without your consent unless required by law. 
 
Your rights to privacy are legally protected by federal and provincial laws that require safeguards 
to insure that your privacy is respected and also give you the right of access to the information 
about you that has been provided to the sponsor and, if need be, an opportunity to correct any 
errors in this information.  Further details about these laws are available on request to your study 
doctor. 

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WHO DO I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY DURING MY 
PARTICIPATION? 
In case of a study-related injury or if you have any questions or desire further information about 
his study before or during your participation, you can contact Dr. Larry Ong at 604-875-4794 
and Dr. Raymond Lam at 604-822-7325. In addition you can contact th Research Subject 
Information Line: toll free 1-877-822-8598, or email them at RSIL@ors.ubc.ca 
 
WHO DO I CONTACT IF I HAVE ANY QUESTIONS OR CONCERNS ABOUT MY 
RIGHTS AS A SUBJECT DURING THE STUDY? 
If you have any concerns about your rights as a research subject and/or your experiences while 
participating in this study, contact the Research Subject Information Line in the University of 
British Columbia Office of Research Services at 604-822-8598. 

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SUBJECT CONSENT 
• I have read and understood the subject information and consent form. 
• I understand that I am not waiving any of my legal rights as a result of signing this 
consent form. 
• I have been given the chance to discuss the study and ask questions. 
• I consent to take part in the study and I am aware my participation is entirely voluntary. 
• I understand that I may withdraw at any time without giving a reason and without this 
affecting my future care. 
• By signing this information and consent form I agree that my personal data, including 
data relating to my physical or mental health or condition, and race or ethnic origin, may 
be used as described in this consent form. 
I have been told that I will receive a copy of this signed and dated  
 
 The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy 
in Civilian Post-Traumatic Stress Disorder study by Dr. Larry Ong 
____________________________ 
Printed name of subject  
 
 
Signature of subject 
 
 
 
 
      
Date of signature  
 
 
Printed name of witness 
 
 
 
 
 
Signature of witness 
 
 
 
 
 
Date of signature 
 
 
Printed name of principal investigator or authorized representative  
 
 
 
Signature of principal investigator or authorized representative 
       Date of signature 
 
 
Printed name of translator 
 
 
 
 
Signature of translator  
 
 
 
 
       Date of signature 
_______________________________________________ 
Language translated into