Neuroimaging in Patients Undergoing TMS for Depression
Phase: NA
Conditions: Treatment Resistant Depression
Sponsor: New York State Psychiatric Institute

Neuroimaging in Patients Undergoing TMS for Depression 
 
NCT02974296 
 
Document Date: June 17, 2019 
 
 

Signed copy on file at IRB 
 
             
v. 4/19/13 
                                          NEW YORK STATE PSYCHIATRIC INSTITUTE         
INSTITUTIONAL REVIEW BOARD 
MEMORANDUM 
 
 
 
 
 
 
 
 
 
June 17, 2019 
TO:  
Dr. Marta Moreno-Ortega 
FROM: 
Dr. Edward V. Nunes, Co-Chair, IRB 
 
 
Dr. Agnes Whitaker, Co-Chair, IRB 
 
SUBJECT: APPROVAL NOTICE: CONTINUATION*** 
 
Your protocol # 7159 entitled Neuroimaging in Patients Undergoing TMS for Depression 
(version date 06-17-19) and consent forms have been approved by the New York State Psychiatric 
Institute - Columbia University Department of Psychiatry Institutional Review Board from June 
17, 2019 to May 25, 2020.  (Reviewed by the Full Board on 06-03-19.) 
 
Consent requirements: 
     
 
      Not applicable: 
          
 
     √ Signature by the person(s) obtaining consent is required to document the consent process.                
 
      Documentation of an independent assessment of the participant’s capacity to consent is also 
required. 
      Approved for recruitment of subjects who lack capacity to consent:  √ No      Yes           
 
    Field Monitoring Requirements: √ Routine      Special:                                    
 
√   Only copies of consent documents that are currently approved and stamped by the IRB 
may be used to obtain consent for participation in this study. 
√  A progress report and application for continuing review is required 2 months prior to the  
expiration date of IRB approval. 
√  Changes to this research may be not be initiated without the review and approval of the  
IRB except when necessary to eliminate immediate hazards to participants.  
√  All serious and/or unanticipated problems involving risks to subjects or others must be 
reported immediately to the IRB.  Please refer to the PI-IRB website at http://irb.nyspi.org 
for Adverse Event Reporting Procedures and additional reporting requirements.  
 
*** This protocol continuation has been approved with the modifications submitted on 05-23-19. 
 
 
CC:  RFMH Business Office (NYSPI MRI center pilot hours; Internal funding (PI: Daniel 
Javitt)) 
 
CU Grants & Contracts (Neuronetics Inc.) 
ENC:  CF (version date 06-07-19 in compliance with revised Common Rule) 
 
HIPAA Form 
 
MRI letters 
 
 
EN/AHW/Scr 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 1 of 36
Protocol Title:
Neuroimaging in Patients Undergoing TMS 
for Depression
Protocol Number:
7159
First Approval:
05/26/2016
Expiration Date:
05/25/2020
Version Date:
06/17/2019
Contact Principal Investigator:
Marta Moreno-Ortega, PHD
Email: mm4355@columbia.edu
Telephone: (646) 774-5432
Co-Investigator(s):
Alayar Kangarlu, PHD
Jack Grinband, PHD
Daniel Javitt, MD, PHD
Research Chief:
Daniel Javitt, MD, PHD
Faculty Sponsor:
Daniel Javitt, MD, PHD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am submitting an annual continuation with modifications
Division & Personnel
Division
What Division/Department does the PI belong to?
Experimental Therapeutics
Within the division/department, what Center or group are you affiliated with, if any? 
None
Unaffiliated Personnel

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 2 of 36
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
DR. Tarique Perera, MD, PhD. 
Director, Contemporary Care Clinics
Amendment
Describe the change(s) being made 
At NYSPI patients will only come for MRI. No patients will be treated at the NYSPI.
Provide the rationale for the change(s) 
Patients will be treated off site by their referral psychiatrist.
Comment on the extent to which the proposed change(s) alter or affect risks/benefits to subjects 
No risks/no benefits.
Comment on if the proposed change(s) require a modification to the Consent Form (CF)
No changes are needed. The MRI Scanning Consent Form will be used for both groups.
Application for Continuation of Research
Status
Current Status of Study: 
Subject enrollment is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to 
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and 
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and 
procedures.
We are in the recruitment phase. Patients' experience have been very pleasant and satisfactory.
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 3 of 36
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in 
the past year which might affect the analysis of the safety, risks or benefits of study participation? 
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to 
subjects or others at this site which occured in the past year)? 
No
Have all study staff with a significant role in the design or implementation of the human subject components 
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality? 
No
Overall Progress
Approved sample size
60
Total number of participants enrolled to date
28
Number of participants who have completed the study to date 
26
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
Yes
Describe actions taken or planned to address these problems. 
The upgrade of the scanner at NYSPI MRI required transferring our imaging protocol to CBIC MRI. The 
development of same protocol took extra time. The protocol is now developed and available.
 
The population of patients from Dr. Tarique Perera in Greenwich (Connecticut) who satisfy 
inclusion/exclussion criteria decreased. Other psychiatrists from his team will help with patients referral.
Comments / additional information 
Sample Demographics
Specify population
Depressed Adults prescribed for the first time to standard TMS
Total number of participants enrolled from this population to date 
24
Specify population #2
Depressed Adults non-responders to standard TMS
Total number of participants enrolled from this population to date 
10

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 4 of 36
Gender, Racial and Ethnic Breakdown 
14 male, 14 women
26 caucasian, 2 other ethnic group
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
1
Number of participants currently enrolled
1
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No
Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   MRI
   Off-label Use of Drug or Device
Population
Indicate which of the following populations will be included in this research
   Adults
   Adults over 50
Research Support/Funding
Will an existing internal account be used to support the project?
Yes
Describe internal account
1. NYSPI MRI center pilot hours.
2. Internal funding, Division of Experimental Therapeutics (retained clinical revenues, PI: Daniel Javitt)
Is the project externally funded or is external funding planned?
Yes

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 5 of 36
Select the number of external sources of funding that will be applicable to this study
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol? 
Yes
Select one of the following
The grant/contract is currently funded
Source of Funding
Industry
Sponsor
Neuronetics Inc.
Is the study investigator initiated? 
Yes
Select one of the following
Single Site
Business Office
CU
Does the grant/contract involve a subcontract? 
No
Study Location
Indicate if the research is/will be conducted at any of the following
   NYSPI
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
Repetitive transcranial magnetic stimulation (rTMS) is a novel method for treating depression, in which a 
magnetic coil is used to stimulate specific regions of the brain. Although the approach has proven effective 
for some individuals with medication-resistant depression others do not benefit from the TMS 
approaches that are presently being used. One reason why some people respond well and others do not may 
have to do with individual variations in brain organization, which would require stimulation to be applied to 
slightly different locations in different individuals. The differences in brain organization can be detected 
using individualized functional MRI scans, which then allow the coil placement to be determined separately 
for each individual. The goal of this project is to guide rTMS using fMRI in individuals with depression who 
did not respond to standard TMS treatment to evaluate whether targeted TMS using individualized 
functional MRI scans produce outcome superior to that of conventional approaches. We will also scan MDD 
patients prescribed to receive standard TMS for the first time before and after which they will have resting-

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 6 of 36
state FMRI scan in order to see if we can predict their responsiveness based on the functional connectivity 
maps. 
 
This protocol will recruit subjects from an ongoing study of rTMS treatment of depression being conducted 
by Dr. Tarique Perera who is a non-Columbia physician, and already approved by an independent IRB 
(WIRB protocol #20141643 entitled: “Cognitive Changes During Treatment with TMS for Major 
Depression”, see attachment). 
Group 1 are patients coming from Dr. Perera’s offices who will be scanned at the NYSPI MRI Unit pre/post 
TMS treatments. TMS treatments for this group will be implemented under Dr. Perera’s protocol and 
WIRB. We will only be doing scanning at the NYSPI. 
Group 2 are patients coming from Dr. Perera’s offices who will come to the NYSPI site to be scanned at the 
NYSPI MRI Unit pre/post TMS treatments and to receive a second course of TMS. For Group 2, we will be 
doing both scanning and treatment. 
 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 7 of 36

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 8 of 36
Background, Significance and Rationale
Background, Significance and Rationale
Significance: There are few therapeutic options for individuals with treatment resistant depression (TRD). 
One recently developed approach is rTMS over left dorsolateral prefrontal cortex. Recent studies have 
demonstrated overall antidepressant benefit of rTMS in patients who fail to respond to a trial of 
antidepressant medication (1, 2, 3). Nevertheless, for many patients the response is incomplete, suggesting 
the need for further optimization. One potential cause of heterogeneous response might relate to individual 
differences in brain anatomy and connectivity patterns. At present, the rTMS stimulation site across subjects 
is based upon fixed location relative to motor cortex. Potentially, however, the approach could be optimized 
by stimulating based upon individual brain functional connectivity pattern. The present project will collect 
pre- and post-treatment brain functional connectivity measures in a group of patients who will be receiving 
independent clinical rTMS for resistant depression, a connectivity-based targeting approach will be applied 
at the single-subject level to individualize therapy in those patients who do not respond to standard 
approaches.
  
The present study is based upon the hypothesis that the clinical efficacy of rTMS reflects functional 
connectivity between left DLPFC and remote regions such as the subgenual cingulate (sgACC), and that the 
precise regions of DLPFC that are functionally connected to sgACC may differ across individuals (4, 5). 
Thus, individualized functional connectivity patterns using standard resting-state functional connectivity 
measures may assist in optimizing rTMS efficacy across individuals.
 
Background: The present research is based upon the theoretical conceptualization of depression as a network 
disorder that reflects alterations in function in a distributed network of regions including DLPFC (especially 
left), medial prefrontal and orbitofrontal cortices, sgACC, insula, thalamus, hypothalamus, and hippocampus 
(HPC). Retrograde tracer studies in nonhuman primates indicate that the DLPFC has reciprocal connections 
with sgACC (6, 7, 8, 9, 10). The sgACC is a key region within the frontolimbic network and has consistently 
been shown to be metabolically hyperactive during depressive episodes (11, 12-16, 14, 15, 17, 18). Voxel-
by-voxel analyses of neurophysiological data from depressed samples versus controls localized the peak 
difference in activity to the sgACC (19). In general, effective antidepressant treatments attenuate this sgACC 
metabolic hyperactivity (20, 14, 16, 21), supporting the importance of this region. Nevertheless, because of 
its deep location sgACC cannot be directly targeted by  non-invasive approaches such as TMS, and thus 
must be manipulated indirectly via networks that may themselves be dysfunctional in depression.
 
The present study is also motivated by extensive literature suggesting that effects of rTMS are not confined 
to the local area of stimulation, but instead propagate beyond the site of stimulation, impacting a distributed 
network of brain regions (22-25). These observations suggest that rTMS may relieve depression by 
modulating synaptic strength both locally and at distant sites modulating functional connectivity in cortical 
networks. Part of the antidepressant mechanism of DLPFC rTMS may be remote suppression of activity in 
the sgACC and other limbic regions (20, 26, 27). Fox et al. (23), showed that target sites with the best rTMS 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 9 of 36
antidepressant efficacy exhibited the strongest anticorrelated resting-state functional connectivity (rsFC) in 
the sgACC.
The present study will test this hypothesis on a group of patients with MDD non-responders to standard 
TMS by conducting pre-treatment functional connectivity to enable targeting of rTMS based upon 
individualized connectivity maps. These locations will then be used at the NYSPI site and also given to the 
treating physician (Tarique Perera) to optimize target for focal brain stimulation and efficacy across 
individuals. Of note, patients from group 1 will be scanned at the NYSPI site but will not receive treatment 
here, whereas group 2 will both be scanned and receive treatment.
Our preliminary data in Fig. 1 shows results acquired from a subset of patients with MDD that reveals an 
increase in anti-correlation between left-DLPFC and sgACC consecutive to convulsive therapy. These 
results suggest that ability to deliver TMS pulse to special targets identified on functional connectivity maps 
(e.g. DLPFC) have the potential to positively confirm their involvement in MDD. Increase in anticorrelation 
of rsFC signal of these regions after TMS would amount to such evidence. This is exactly what we observed 
in convulsive therapy as is shown in Fig 1 in which green-blue-purple spectrum on the sgACC rsFC maps 
are the surface vertexes within BA46 with highest anticorrelation BOLD signal with sgACC. We seek to 
replicate this effect with targeted TMS in non-responders to standard TMS. Such strategy has the potential to 
optimize therapeutic efficacy of TMS (see Fig. 1, attached).
 
Our justification for committing the non-responders to a second cycle of TMS is as following:
1)
The second cycle will use an entirely different type of TMS, i.e. neuronavigated TMS based on the 
functional connectivity maps obtained from patients’ brain which offers, hereto-forth, the best guide for the 
efficacy of TMS as shown in Fig. 1.
2)
Since the patients for the second cycle are randomized to receive either neuronavigated or standard 
TMS, we can justify a second cycle of standard TMS by statistics from Dr Perera’s clinics which are in 
agreement with application guidelines for the use of TMS ( Rossi et al., 2009). As for Dr Perera’s past 
experience is concerned, of the 139 patients that received 9 weeks of TMS, 60 responded at the 4 week 
point and 89 responded at the 8 week point. Of the 79 that did not respond at the 4 week measurement, 42 
(more than 50%) responded at the week 8 point. Response is defined here as a 50% or greater reduction in 
starting Ham D score. As such, while the advantage of the second round of TMS is clear for the patients 
who receive neuronavigated TMS, even for the patients who receive the second round of standard TMS the 
above facts demonstrate the advantages of prolonged (4-8 week) treatment by TMS in the form of a 50% 
favorable outcome in that group of patients.
In addition to resting state functional connectivity, we will also assess glutamate (Glu) concentrations and 
resting-state cerebral blood flow/volume (rsCBF/rsCBV) in DLPFC and cortical midline structures (CMS) 
using Magnetic Resonance Spectroscopy (MRS) and Arterial Spin Labelling (ASL), respectively. CMS refer 
to brain structures situated near the medial wall of the brain and is mainly comprised of the ventral medial 
prefrontal cortex, dorsal medial prefrontal cortex, anterior cingulate cortex (the supragenual part in 
particular) and posterior cingulate cortex. Regional increases in Glu release increase the metabolic rate of 
post-synaptic neurons (28), and surrounding astrocytes (29), leading to regional BOLD signal increases (30). 
Glu concentrations may therefore be linked to overall functional connectivity patterns (31-34). In particular, 
Glu levels in left DLPFC in MDD provide an index of local metabolic activity, and abnormalities can be 
reversed in a dose-dependent manner by rTMS (35). These effects are present not only close to the 
stimulation site (left DLPFC), but also in remote (right DLPFC, left cingulate cortex) brain regions. 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 10 of 36
Abnormal reduction of sgACC cerebral blood flow (CBF) and glucose metabolism in MDD have also been 
found (36-39). These apparently discrepant results have been explained by the interrelationships between 
deficits in gray matter volume and physiological imaging data. The reduction in sgACC volume produce 
partial volume effects in functional brain images due to their relatively low spatial resolution, when this 
volumetric deficit is taken into account by correcting the metabolic data for the partial volume averaging 
effect associated with the corresponding gray matter reduction, metabolism instead appeared increased in the 
sgACC in the unmedicated-depressed phase and normal in the medicated-remitted phase (40). 
 
Although MRS Glu levels and rsCBF/rsCBV will not be used to guide treatment location in the present 
study, nevertheless they will be analyzed to see if they can differentiate responders from non-responders to 
rTMS treatment approaches. fMRI, MRS and CBF/CBV procedures will be repeated following completion 
of the clinical protocol in order to evaluate potential clinical correlates of symptomatic improvement.
 
Specific Aims and Hypotheses
Specific Aims and Hypotheses
Specific aims of the project are as follows: 
 
1)     To conduct functional connectivity fMRI scans in a group of non-responders to standard TMS 
participating in an external rTMS clinical treatment protocol in order to permit individualized target location 
for targeted rTMS treatment. To personalize therapy, a functional connectivity-based targeting approach will 
be used to identify optimal TMS target coordinates in the left-DLPFC.
  
2)     To determine whether fMRI functional connectivity, glu MRS and CBF/CBV abnormalities are 
associated with treatment outcome to rTMS.
 
3)     To identify biological marker outcomes to treatment response as measured by 3-tesla MRI.  
We hypothesize that individual differences in connectivity between DLPFC and sgACC are large and can be 
used to generate individualized TMS targets that will result in response rates higher than those traditionally 
associated with rTMS. In addition, we hypothesize that pretreatment DLFPC and CMS glu levels and 
CBF/CBV abnormalities will assist in identification of treatment-responsive subjects.

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 11 of 36

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 12 of 36
Description of Subject Population
Sample #1
Specify subject population
Depressed Adults prescribed for the first time to standard TMS
Number of completers required to accomplish study aims
60
Projected number of subjects who will be enrolled to obtain required number of completers
70
Age range of subject population
18-60
Sample #2
Specify subject population
Depressed Adults non-responders to standard TMS
Number of completers required to accomplish study aims
30
Projected number of subjects who will be enrolled to obtain required number of completers
35
Age range of subject population
18-60
Gender, Racial and Ethnic Breakdown
Given the gender difference in the prevalence of major depression, it is expected that approximately 2/3 
of the sample will be female. Expected ethnic breakdown is: 80% Caucasian, 10% African-American, 10% 
Hispanic or other ethnic group.
Description of subject population
All patients will be adults aged 18-60 who are to receive targeted rTMS for their depressive symptoms. 
After passing all screening criteria, participants may still have their participation in the study ended if they 
do not comply with study procedures, if there is a change in their medical status, or if an adverse event has 
occurred. 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 13 of 36
Recruitment Procedures
Describe settings where recruitment will occur
Patients will be referred from private psychiatric facilities run by Tarique Perera, MD, and will be selected 
from those already participating in an approved clinical study of rTMS for treatment resistant depression 
(WIRB protocol #20141643 entitled: “Cognitive Changes During Treatment with TMS for Major 
Depression”, see attachment). 
How and by whom will subjects be approached and/or recruited? 
Dr. Tarique Perera will tell potential participants about the current study, using the consent form cover sheet 
and flyers for patients and doctors to describe the types of procedures involved. Potential participants 
interested in learning more will receive Dr. Moreno’s contact information from Dr. Perera to call and make 
an appointment at NYSPI for a visit with her and Drs. Stewart and Hellerstein. (Please find the Screening 
Phone call Script attached). Screening protocol from Jonathan W. Stewart’s IRB # 6669R titled “Evaluation 
of Potential Participants for Depression Evaluation Service (DES) Research” will also be used.   
How will the study be advertised/publicized? 
The consent form cover sheet will be attached to other administrative forms that are part of the patients’ 
office visits. An explanation illustrated with images will be presented to patients/controls by the PI previous 
to enrollment (attached). Flyers for patients and doctors are attached of review.
Do you have ads/recruitment material requiring review at this time? 
No
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT02974296
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes
Describe concurrent research involvement
WIRB Protocol #20141643, “Cognitive Changes During Treatment with TMS for Major Depression”, 
Tarique Perera, MD, Principal Investigator; or
NYSPI IRB Protocol #6669R, “Evaluation of Potential Participants for Depression Evaluation Service 
(DES) Research”, Jonathan Stewart, MD, Principal Investigator

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 14 of 36
If participants were enrolled in either of these studies and the screening evaluations were conducted 
within the prior six months, copies of all screening instruments will be made and reviewed by the 
study Principal Investigator. Eligibility would be determined based upon the results of the existing 
evaluations and the Principal Investigator will document their continued validity.
 
 
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Depressed patients prescribed for the first time to standard TMS
Create or insert table to describe the inclusion criteria and methods to ascertain them
Eligibility screening may be conducted under
WIRB Protocol #20141643, “Cognitive Changes During Treatment with TMS for Major Depression”, 
Tarique Perera, MD, Principal Investigator; or
NYSPI IRB Protocol #6669R, “Evaluation of Potential Participants for Depression Evaluation Service 
(DES) Research”, Jonathan Stewart, MD, Principal Investigator
If participants were enrolled in either of these studies and the screening evaluations were conducted 
within the prior six months, copies of all screening instruments will be made and reviewed by the 
study Principal Investigator. Eligibility would be determined based upon the results of the existing 
evaluations and the Principal Investigator will document their continued validity.
 
Inclusion criteria 
1.
Male or female outpatients, 18 to 60 years of age. Self report
2.
Primary diagnosis of Major Depressive Disorder as confirmed by the Structured Clinical Interview 
for DSM-IV Disorders (SCID-IV). SCID, DSM-IV
3.
Duration of the index episode of at least 2 weeks. Psychiatric History
4.
MDD symptoms, defined as a total HDRS-17 score ≥ 18 despite treatment with an adequate trial of a 
serotonin reuptake inhibitor (SRI). An adequte SRI trial is defined as treatment for at least 6-8 weeks on the 
SRI, that meets the maximum recommended dosage level for MDD (fluoxetine 40-60 mg/d, sertraline 100- 
200 mg/d, paroxetine 40-60 mg/d, fluvoxamine 200-300 mg/d, citalopram 40-60 mg/d, escitalopram 20-30 
mg/d). We do not typically rely on an arbitrary upper cut-off on the HRSD because an arbitrary cut-off 
number would not capture the clinical salience of individual symptoms and clinical judgment must 
supersede (e.g. a HRSD of 18 but in the presence of active suicidal ideation and plan would exclude patient). 
HDRS-17/Clinician Psychiatric History
5.
Individuals who cannot tolerate medications of class and dose at the specified duration defined in 
inclusion item #4. Psychiatric History
6.
Patients currently on medication must be at the same stable dose(s) for 1 month prior to enrollment 
and be willing to continue at the same dose(s) through the duration of the study. Physician Evaluation 
7.
Capable and willing to provide informed consent Physician Evaluation 
8.        Signed HIPAA authorization. Physician Evaluation

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 15 of 36
9. Willingness to undergo research fMRI scan (3T).
10. Willingness to undergo randomization to either treatment arm. 
11. Left/Right-handed. Edinburgh Handedness Questionnaire
Create or insert table to describe the exclusion criteria and methods to ascertain them
1.         Investigators, and their immediate families (defined as a spouse, parent, child or sibling, whether by 
birth or legal adoption). Self Report
2.
Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), 
any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (except 
nicotine and caffeine). Physician Evaluation SCID, DSM-IV
3.
Behavior, which in the judgment of the investigator may hinder the patient in completing the 
procedures required by the study protocol. Physician Evaluation Private Psychiatrist Reports
4.
Individuals with a clinically defined neurological disorder including, but not limited to: tics, space 
occupying brain lesion; any history of seizures except those therapeutically induced by ECT; history of 
cerebrovascular accident; history of fainting; transient ischemic attack within two years; cerebral aneurysm, 
Dementia; Parkinson’s Disease; Hungtington chorea; Multiple Sclerosis. Physician Evaluation Medical 
Records 
5.
Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure 
(such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness 
for ≥ 5 minutes. Patients Reports
6.
Use of any investigational drug within 12 weeks of the randomization visit. Patients Reports
7.
Significant acute suicide risk, defined as follow: suicide attempt within the previous 6 months that 
required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or in the investigator’s opinion, 
has significant risk for suicide based on the current state or recent history. Physician Evaluation
8.
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac 
disease. Physician Evaluation
9.
Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or 
any other metal object within or near the head, excluding the mouth, that cannot be safely removed. 
Physician Evaluation MRI Screening Form
10.
Current illicit drug use (cannabinoid, phencyclidine, amphetamines, barbiturates, cocaine, 
methadone, and opiates), defined as drug use during the 6 months before screening. Physician Evaluation
11.
Known or suspected pregnancy. Urine pregnancy test Women who are breast-feeding. Self Report
12.
Women of childbearing potential not using a medically accepted form of contraception when 
engaging in sexual intercourse. Self Report
13.
Medicinal patch, unless removed prior to the MR scan. Clinical interview
14. MDD patients with very severe depression, defined as a total HDRS-17 score ≥ 23, will be excluded and 
referred to immediate treatment.
15. Risks related to seizures, such as substance abuse or sleep disruptions/insomnia. Clinician Psychiatric 
History. SCID.
16. History of treatment with rTMS therapy for any disorder. Patients Reports. 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 16 of 36
Inclusion/Exclusion Criteria #2
Name the subject group/sub sample
Depressed patients non-responders to standard TMS
Create or insert table to describe the inclusion criteria and methods to ascertain them 
Eligibility screening may be conducted under
WIRB Protocol #20141643, “Cognitive Changes During Treatment with TMS for Major Depression”, 
Tarique Perera, MD, Principal Investigator; or
NYSPI IRB Protocol #6669R, “Evaluation of Potential Participants for Depression Evaluation Service 
(DES) Research”, Jonathan Stewart, MD, Principal Investigator
If participants were enrolled in either of these studies and the screening evaluations were conducted 
within the prior six months, copies of all screening instruments will be made and reviewed by the 
study Principal Investigator. Eligibility would be determined based upon the results of the existing 
evaluations and the Principal Investigator will document their continued validity.
 
Inclusion  criteria: 
1.              Male or female outpatients, 18 to 60 years of age. Self report
2.              Primary diagnosis of Major Depressive Disorder as confirmed by the Structured Clinical 
Interview for DSM-IV-TR Disorders (SCID-IV-TR). SCID, DSM-IV-TR
3.              Duration of the index episode of at least 2 weeks. Psychiatric History
4.              MDD symptoms, defined as a total HDRS-17 score ≥ 18 despite treatment with an adequate trial 
of a serotonin reuptake inhibitor (SRI). An adequte SRI trial is defined as treatment for at least 6-8 weeks on 
the SRI, that meets the maximum recommended dosage level for MDD (fluoxetine 40-60 mg/d, sertraline 
100- 200 mg/d, paroxetine 40-60 mg/d, fluvoxamine 200-300 mg/d, citalopram 40-60 mg/d, escitalopram 
20-30 mg/d). We do not typically rely on an arbitrary upper cut-off on the HRSD because an arbitrary cut-
off number would not capture the clinical salience of individual symptoms and clinical judgment must 
supersede (e.g. a HRSD of 18 but in the presence of active suicidal ideation and plan would exclude 
patient). HDRS-17/Clinician Psychiatric History
5.              Individuals who cannot tolerate medications of class and dose at the specified duration defined in 
inclusion item #4. Psychiatric History
6.              Patients currently on medication must be at the same stable dose(s) for 1 month prior to 
enrollment and be willing to continue at the same dose(s) through the duration of the study. Physician 
Evaluation 
7.              Capable and willing to provide informed consent. Physician Evaluation
8.        Signed HIPAA authorization. Physician Evaluation
9.        Left/Right-handed. Edinburgh Handedness Questionnaire
10.      Willingness to undergo research fMRI scan (3T).
11.      Willingness to undergo randomization to either treatment arm.  
12.      History of NON-response to rTMS in THIS depressive episode. Assessment of history from patient 
and/or Clinical Psychiatric History from Dr. Perara's office
 
Create or insert table to describe the exclusion criteria and methods to ascertain them 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 17 of 36
1.              Investigators, and their immediate families (defined as a spouse, parent, child or sibling, whether 
by birth or legal adoption). Self Report 
2.              Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder 
(lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year 
(except nicotine and caffeine). Physician Evaluation SCID, DSM-IV-TR
3.              Behavior, which in the judgment of the investigator may hinder the patient in completing the 
procedures required by the study protocol. Physician Evaluation Private Psychiatrist Reports
4.              Individuals with a clinically defined neurological disorder including, but not limited to: tics, 
space occupying brain lesion; any history of seizures except those therapeutically induced by ECT; history 
of cerebrovascular accident; history of fainting; transient ischemic attack within two years; cerebral 
aneurysm, Dementia; Parkinson’s Disease; Hungtington chorea; Multiple Sclerosis. Physician Evaluation 
Medical Records 
5.              Increased risk of seizure for any reason, including prior diagnosis of increased intracranial 
pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of 
consciousness for ≥ 5 minutes. Patients Reports
6.              Use of any investigational drug within 12 weeks of the randomization visit. Patients Reports
7.              Significant acute suicide risk, defined as follow: suicide attempt within the previous 6 months 
that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or in the investigator’s 
opinion, has significant risk for suicide based on the current state or recent history. Physician Evaluation
8.              Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac 
disease. Physician Evaluation
9.              Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) 
or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. 
Physician Evaluation MRI Screening Form
10.              Current illicit drug use (cannabinoid, phencyclidine, amphetamines, barbiturates, cocaine, 
methadone, and opiates), defined as drug use during the 6 months before screening. Physician Evaluation
11.              Known or suspected pregnancy. Urine pregnancy test Women who are breast-feeding. Self 
Report
12.              Women of childbearing potential not using a medically accepted form of contraception when 
engaging in sexual intercourse. Self Report
13.              Medicinal patch, unless removed prior to the MR scan. Clinical interview
14.              MDD patients with very severe depression, defined as a total HDRS-17 score ≥ 23, will be 
excluded and referred to immediate treatment.
15.              Risks related to seizures, such as substance abuse or sleep disruptions/insomnia. Clinician 
Psychiatric History. SCID.
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 18 of 36
Waiver or alteration of consent
Yes
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
Yes
Indicate NYSPI IRB # 
6669R
Describe Study Consent Procedures
Eligibility screening may be conducted under
WIRB Protocol #20141643, “Cognitive Changes During Treatment with TMS for Major Depression”, 
Tarique Perera, MD, Principal Investigator; or
NYSPI IRB Protocol #6669R, “Evaluation of Potential Participants for Depression Evaluation Service 
(DES) Research”, Jonathan Stewart, MD, Principal Investigator
If participants were enrolled in either of these studies and the screening evaluations were conducted within 
the prior six months, copies of all screening instruments will be made and reviewed by the study Principal 
Investigator. Eligibility would be determined based upon the results of the existing evaluations and the 
Principal Investigator will document their continued validity. 
 
The individual obtaining 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.
 
Indicate which of the following are employed as a part of screening or main study consent procedures
   Consent Form
Justification for Waiver or Alteration of Consent
Waiver of consent is requested for the following
A phone screen will be used for this study. Eligibility screening for this study will be conducted under this 
IRB protocol. 
Explain why your research can not be practicably carried out without the waiver or alteration
Dr. Moreno will screen patients on the phone before first visit to NYSPI. 
Describe whether and how subjects will be provided with additional pertinent information after participation

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 19 of 36
Patients will receive additional information if requested. Results of clinical assessments and a picture of 
patient's functional connectivity map with the subgenual region will be available.
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
2
Hellerstein, David, MD
Moreno-Ortega, Marta, PHD
Type in the name(s) not found in the above list

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 20 of 36
Study Procedures
Describe the procedures required for this study
Eligibility screening may be conducted under
WIRB Protocol #20141643, “Cognitive Changes During Treatment with TMS for Major Depression”, 
Tarique Perera, MD, Principal Investigator; or
NYSPI IRB Protocol #6669R, “Evaluation of Potential Participants for Depression Evaluation Service 
(DES) Research”, Jonathan Stewart, MD, Principal Investigator
If participants were enrolled in either of these studies and the screening evaluations were conducted within 
the prior six months, copies of all screening instruments will be made and reviewed by the study Principal 
Investigator. Eligibility would be determined based upon the results of the existing evaluations and the 
Principal Investigator will document their continued validity. 
 
This protocol will recruit subjects from an ongoing study of rTMS treatment of depression being conducted 
by Dr. Tarique Perera who is a non-Columbia physician, and already approved by an independent IRB 
(WIRB protocol #20141643 entitled: “Cognitive Changes During Treatment with TMS for Major 
Depression”, see attachment).
 
At NYSPI or at CBIC (Citigroup Biomedical Imaging Center at Weill Cornell Medical College) MRI 
facility all patients will come to have a brief conversation with Dr. Moreno to verify eligibility to participate 
in this study, and to complete fMRI scans. Clinical assessments pre/post TMS treatments will be 
implemented at Contemporary Care or NYSPI. Patients will complete some assessments using 
StudyTrax.
 
Group 1 are patients coming from Dr. Perera’s offices who will be scanned at the NYSPI or CBIC MRI Unit 
pre/post TMS treatments. TMS treatments for this group will be implemented under Dr. Perera’s protocol 
and WIRB. Group 2 are patients coming from Dr. Perera’s offices who will come to the NYSPI or CBIC 
site to be scanned at the NYSPI or CBIC MRI Unit pre/post TMS treatments. A second course of TMS will 
be imoplemented at any of Dr. Perera’s offices (only). For both, Group 1 and Group 2, we will be 
doing the scanning only (at NYSPI or CBIC) (Table 1. Timing of all Study Procedures attached). No 
treatments will be implemented at NYSPI. 
 
Overview of Study Design:
Patients from Dr. Perera’s offices will be divided in 2 groups. Group 1 (N=30) will be depressed patients 
undergoing standard TMS for the first time. Group 2 (N=30) constitutes those who have previously 
demonstrated that they do not respond to standard TMS. MDD patients prescribed to receive standard TMS 
for the first time (group 1) will have resting-state FMRI in order to see if we can predict their 
responsiveness based on the functional connectivity maps. Non-responders to standard TMS approaches 
(Group 2) will be randomized (3:2) to either receive targeted (N=20) or standard (N=10) repetitive TMS 
(rTMS) treatments. A connectivity-based targeting strategy will be used on patients undergoing targeted 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 21 of 36
rTMS to optimize target for focal brain stimulation. Response is defined as a 50% or greater reduction in 
starting HDRS score. Raters and patients in group 2  will be kept blinded to the treatment assignment. All 
patients referred from the ongoing treatment study will be assessed by 3 tesla brain MRI, MRS and 
CBF/CBV procedures at baseline and immediately following the final treatment. At NYSPI we will only do 
the imaging component. All treatments will be implemented at any of Dr. Perea's offices.
Patients from group 1 will be scanned at the NYSPI or CBIC MRI Unit pre/post TMS treatments. TMS 
treatments for this group will be implemented under Dr. Perera’s protocol and WIRB. Patients from group 
2, will receive another cycle of standard versus targeted TMS, 5 times a week for 6 weeks (30 treatments), 
followed by a taper phase of 6 sessions to cover 3 treatments in week 1, 2 treatments in week 2 and 1 
treatment in week 3. For these patients, second visit to NYSPI or CBIC will occur after first cycle finishes 
and right before second cycle begins. Also will receive a second post-TMS scan after second cycle finishes 
(see Diagram 3). Patients will be classified as responders to TMS with at least 50% decrease in HDRS-24 
scores from baseline. Patients will be classified as non-responders to TMS with less than 50% decrease in 
HDRS-24 scores from baseline. 
Screening:
A phone screen will be used for this study (NT TMS Screening Phone call Script attached). Patients will 
come to the NYSPI to meet with Dr. Moreno to verify eligibility, and after the patient signs the informed 
consent form and the HIPAA authorization, will undergo clinical assessments to assure adherence to all 
inclusion and exclusion criteria. Eligible patients will be enrolled in the study. 
Dr. Moreno will explain to patients that at NYSPI they will only come for the imaging component and 
that no treatments will be implemented at the NYSPI site. 
  
MRI, MRS and CBF/CBV Scanning:
 
Subjects will undergo 3 tesla (3T) brain MRI-MRS-CBF/CBV scanning. None of the imaging modalities 
used in the study will include exogenous contrasts. MRI scans will be performed at the NYSPI or CBIC 
MRI facility immediately before and after the rTMS treatment. 1H MRS PRESS TE80, ASL, FSPGR, 
resting state MB EPI (BOLD) will be performed at 3T. Dr. Kangarlu will be responsible of Multiband EPI, 
PRESS and ASL for this study. To identify coordinates in the left DLPFC we will use functional 
connectivity (FC) seed based analysis centered on left DLPFC ROIs to identify the site (X) with peak 
anticorrelation with the sgACC.
  
DLPFC Mapping for targeted TMS (for group 2):
 
Targets for focal brain stimulation with repetitive TMS will be modified based on the MRI. Methodology as 
follow:
I. The subgenual region of interest (ROI) was constructed by placing a 5 mm radius sphere at MNI 
coordinates (6, 16, −10), masked to include only sampled grey matter voxels. These subgenual coordinates 
were chosen based on prior studies where a reduction in subgenual activity was associated with 
antidepressant response across a wide range of treatment modalities (Fox et al., 2012). Resting state 
functional connectivity across 500 healthy right-handed subjects from the Human Connectome Project data 
release (http://www.humanconnectome.org/data/) was used for initial analyses as an independent cohort to 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 22 of 36
construct an average group-level functional connectivity map. The entire subgenual functional connectivity 
map generated from this independent cohort was used as a mask to extract the average time course activation 
from each MDD patient. 
II. Use Matlab software to generate spheres of varying radii on T1W anatomical images centered on node 
coordinates within the left DLPFC to account for varying focality of different potential cortical stimulation 
sites. This procedure will include the mapping of ROI spheres to the surface of MNI space, extract the time 
series courses and compute the correlation with the subgenual functional connectivity map to find the ROI 
with the highest anticorrelation value (X) that could serve as optimized target for focal brain stimulation. 
Next, we will warp the best ROI (X) into the subject native volume space for neuronavigation of TMS coil.
 
TMS Treatments (for group 2):
 
All standard TMS treatments for group 1 will be implemented at any of Dr. Perera's offices. 
Second cycle of TMS treatments for group 2 will be implemented at any of Dr. Perera's offices. 
Subjects of this group will be randomized to either receive standard versus navigated TMS (3:2). Patients 
will receive a total of 36 TMS treatments, 5 times a week for the first 6 weeks (30 treatments), followed by 
a taper phase go 6 sessions to cover 3 treatments in week 1, 2 treatments in week 2 and 1 treatment in week 
3.
  
Using the NeuroStar Therapy System, the subject’s motor threshold (MT) will be determined and the coil 
placed over the left DLPFC guided by Brainsight Neuronavigation device, which uses MRI images loaded 
into the system to navigate the coil over the target within the DLPFC. All patients from group 2 will receive 
stimulation over the left DLPFC at 120% of the MT at a frequency of 10Hz; for a total of 3,000 pulses per 
session. A total of 36 treatment sessions will be provided over 9-weeks. All treatments will be 
implemented outside the NYSPI.
 
The NeuroStar TMS Therapy System is the first TMS device cleared by the U.S. Food and Drug 
Administration (FDA) to treat patients with Major Depressive Disorder (MDD) who have not benefited 
from antidepressant treatment. Treatment parameters in this study will follow FDA approval, i.e. stimulation 
pattern, time course, device and patient population. The "standard" procedure of coil positioning locates the 
left DLPFC at 5-cm anterior to the "hand motor hotspot" along the curvature of the scalp. Alternate 
stimulation site within the DLPFC in each patient will be used to personalize treatments based on their 
rsfMRI, therefore its application is considered off-label. Please find IDE Decision Worksheet in additional 
documents related to this study (uploads section).
 
Brainsight for TMS:
 
Brainsight is what is generally referred to as a neuronavigator (also often called a frameless stereotaxy 
device). Its main function is analogous to a GPS, but applied to the brain. The device takes as input, the 
structural MR images of the subject, and using an infrared position sensor and related accessories, maps the 
location and orientation of a TMS coil held on the subject’s head to the images and displays a representation 
of the coil on the images.
This provides two important functions. First, it displays a live representation of the coil on the images on the 
computer screen, allowing the operator to accurate to use the MR images (and the anatomy shown by the 
images) to determine the location of the coil on the subject’s head. Second, fMRI images may be overlaid 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 23 of 36
on the structural images. These images may be used to define a location in the brain to be stimulated and the 
coordinates of this target stored. While holding the coil on the head, Brainsight indicates in which director 
to move the coil to quickly and accurately place the coil over the target. One placed, the system monitors the 
coil’s activity and can automatically record the coil’s position and orientation w.r.t. target for quality 
assurance. In addition to the coil, the subject’s head is also being monitored, so head movement is shown 
allowing immediate adjustment to the coil or head location to ensure consistent stimulation during the entire 
TMS session. 
Dr. Roch Comeau, president of Rogue Research Inc., is a consultant in this research project to support the 
portions of the project related to the use of the neuronavigation system and has adapted both navigators to 
work with Neuronetics stimulator. Please find Dr. Comeau's Letter uploaded in additional documents related 
to this study (uploads section). Rogue Research, Inc. is the company responsible for neuronavigation. Dr. 
Roch Comeau, President of Rogue Inc, will be available to ensure procedures for neuronavigation are 
followed accurately. He has already come to Contemporary Care to interface the Neuronavigational device 
with NeuroStar TMS devices to ensure proper use of neuronavigation to guide TMS coil. 
 
An IDE is not required for the Brainsight Neuronavigation stereotaxic device. Please find attached a letter 
from Dr. Comeau, who is President of Brainsight Neuronavigation company that manufactures the device. 
 
Criteria for Early Discontinuation:
 
CGI-Global, HDRS-24 and C-SSRS will be assessed weekly in patients undergoing second course of TMS 
at any of Dr. Perera's offices, not at NYSPI. A licensed MD assigned to the study will meet with patients 
weekly and assess clinical worsening, suicidality, and intolerable side effects. If patients show a worsening 
of their general psychopathological condition with 50% increase in HDRS-24 scores from baseline on 2 
consecutive ratings or any occurrence of a CGI-I score of 6 or 7 will trigger a clinical evaluation and then a 
clinical judgment as to wether the patient should be discontinued. Such evaluations will be documented in 
the patient’s chart at Contemporary Care. If patients miss any three consecutive treatment sessions or any 
five treatment sessions, they will be dropped from the study, and after treatment recommendations they will 
be returned to routine clinical management under the supervision of Dr. Perera.
 
In case patients appear to be at increased risk for suicide, he/she will be dropped from the study and 
accompanied to the ER for evaluation. Additionally, intolerable side effects or any medical worsening will 
result in immediate withdrawal from the study. All patients dropped out from the study will be returned to 
routine clinical management under the supervision of Dr. Perera.
Review for any incidental findings on MRI:
 
In adherence to the revised Incidental Findings Policy for neuroimaging done at Columbia as described in 
the 3/27/15 memo from the CUMC IRB, MRI research scans will be read by credentialed neuroradiologists 
within 2 weeks. The subject or his or her individual physician will be contacted by letter with information 
about their MRI research scan.
You can upload charts or diagrams if any

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 24 of 36
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
CGI-Global, HDRS-24 and C-SSRS will be assessed weekly in patients undergoing second course of TMS 
at any of Dr. Perera's offices, not at NYSPI. A licensed MD assigned to the study will meet with patients 
weekly and assess clinical worsening, suicidality, and intolerable side effects. If patients show a worsening 
of their general psychopathological condition with 50% increase in HDRS-24 scores from baseline on 2 
consecutive ratings or any occurrence of a CGI-I score of 6 or 7 will trigger a clinical evaluation and then a 
clinical judgment as to wether the patient should be discontinued. Such evaluations will be documented in 
the patient’s chart at Contemporary Care. If patients miss any three consecutive treatment sessions or any 
five treatment sessions, they will be dropped from the study, and after treatment recommendations they will 
be returned to routine clinical management under the supervision of Dr. Perera or their referring 
psychiatrist.
 
In case patients appear to be at increased risk for suicide, he/she will be dropped from the study and 
accompanied to the ER for evaluation. Additionally, intolerable side effects or any medical worsening will 
result in immediate withdrawal from the study. All patients dropped out from the study will be returned to 
routine clinical management under the supervision of Dr. Perera or their referring psychiatrist.
Blood and other Biological Samples
Please create or insert a table describing the proposed collection of blood or other biological specimens
Not applied.
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
Depressed Patients: 
Assessments, including SCID and HRSD will be performed as part of the referring protocol, as listed below. 
No independent assessments will be performed as part of the present  study.
Dr. Tarique Perera, WIRB protocol #20141643 entitled: “Cognitive Changes During Treatment with TMS 
for Major Depression”, see attachment.
 
Clinical Assessments at the NYSPI site will include:
1. Interview for DSM-IV-TR Disorders (SCID-IV-TR). SCID, DSM-IV-TR
2. HRSD28-MADRS Interview
3. HDRS-24 
4. CGI-Global
5. C-SSRS 
6. The Dimensional Anhedonia Rating Scale (DARS) 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 25 of 36
7. The Ruminative Responses Scale (RRS) 
8. The Selective Reminding Test (SRT) 
9. The Digit Symbol Substitution Test (DSST) 
10. Speech Recognition Threshold (SRT) 
11. The Controlled Oral Word Association Test (COWAT) 
 
Please find Table 2. Clinical Assessments attached. 
Please attach copies, unless standard instruments are used
Off label and investigational use of drugs/devices
Choose from the following that will be applicable to your study 
   Device
Off label and investigational use of devices
Device #1
Name of the device
NeuroStar TMS Therapy System
Manufacturer and other information
NeuroStar TMS Therapy System, Neuronetics Inc.
The NeuroStar TMS Therapy System is the first TMS device cleared by the U.S. Food and Drug 
Administration (FDA) to treat patients with Major Depressive Disorder (MDD) who have not benefited 
from antidepressant treatment. Treatment parameters in this study will follow FDA approval, i.e. stimulation 
pattern, time course, device and patient population. The "standard" procedure of coil positioning locates the 
left DLPFC at 5-cm anterior to the "hand motor hotspot" along the curvature of the scalp. Alternate 
stimulation site within the DLPFC in each patient will be used to personalize treatments based on their 
tfMRI, therefore its application is considered off-label.
Approval Status
No IDE is required
Choose one of the folowing options
Device is 'Non-significant risk'
Explain
The "standard" procedure of positions the coil on the left DLPFC at 5-cm anterior to the "hand motor 
hotspot" along the curvature of the scalp (4, 8-11). However, this technique misses the DLPFC (6, 7) more 
than 1/3 of the times, since it does not account for differences in skull size or variations in prefrontal 
anatomy relative to motor cortex location. 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 26 of 36
We have designed a functional connectivity-based targeting strategy (NT TMS) that allows us to select the 
 target within DLPFC with much higher accuracy to assure individualized target location. This strategy is 
based upon the hypothesis that the clinical efficacy of rTMS depends on the FC between left DLPFC and 
remote regions such as the sgACC, and that the precise regions of DLPFC that are functionally connected to 
sgACC may differ across individuals. Thus, individualized FC patterns using standard rsFMRI FC measures 
offers the target for engagement of TMS across individuals more precisely. Such new targeting (NT) 
strategy for TMS is a novel intervention backed up by strong evidence from the scientific community and 
well-supported theoretical rationale that is ready for early-phase testing. Our proposed NT TMS has a high 
potential to reduce the burden of depression by precisely aiming the intervention to the sites directly 
involved in the networks known to be faulty in the brain of MDD patients. 
 
References
4. F. Padberg, M. S. George, Repetitive transcranial magnetic stimulation of the prefrontal cortex in 
depression. Exp Neurol 219, 2-13 (2009).
6. U. Herwig, F. Padberg, J. Unger, M. Spitzer, C. Schonfeldt-Lecuona, Transcranial magnetic stimulation 
in therapy studies: examination of the reliability of "standard" coil positioning by neuronavigation. Biol 
Psychiatry 50, 58-61 (2001).
7. R. Ahdab, S. S. Ayache, P. Brugieres, C. Goujon, J. P. Lefaucheur, Comparison of "standard" and 
"navigated" procedures of TMS coil positioning over motor, premotor and prefrontal targets in patients with 
chronic pain and depression. Neurophysiol Clin 40, 27-36 (2010).
8. J. P. O'Reardon et al., Efficacy and safety of transcranial magnetic stimulation in the acute treatment of 
major depression: a multisite randomized controlled trial. Biol Psychiatry 62, 1208-1216 (2007).
9. M. S. George et al., Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in 
depression. Neuroreport 6, 1853-1856 (1995).
10. A. Pascual-Leone, B. Rubio, F. Pallardo, M. D. Catala, Rapid-rate transcranial magnetic stimulation of 
left dorsolateral prefrontal cortex in drug-resistant depression. Lancet 348, 233-237 (1996).
11. M. S. George et al., Changes in mood and hormone levels after rapid-rate transcranial magnetic 
stimulation (rTMS) of the prefrontal cortex. J Neuropsychiatry Clin Neurosci 8, 172-180 (1996). 
Device #2
Name of the device
Brainsight TMS Neuronavigation
Manufacturer and other information
Rogue Research, Inc is themanufacturer.
Brainsight coordinate measurement device is designed for TMS applications.
 
Approval Status
No IDE is required
Choose one of the following options
Device is 'Non-significant risk'

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 27 of 36
Explain
Brainsight Neuronavigation enables the TMS coil to be positioned over a specific target location based upon 
individual's MRI image. Brainsight does not provide any diagnostic or therapeutic information for TMS.
 
We have spoken to the company and their understanding is that an IDE is not required. Please find attached 
a letter from Dr. Comeau in the uploads section of the PSF, who is President of Brainsight Neuronavigation 
company that manufactures the device. His understanding is that there are already other Brainsight devices 
at Columbia that are being used without IDE.
 
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
Yes
Maximum duration of delay to any treatment 
No treatment is provided at NYSPI. Participation in this protocol may result in a brief (1 week)

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 28 of 36
delay in treatment implementation by Dr. Perera in order to allow time for the fMRI mapping for targeted 
rTMS to be performed (see Study procedures).
Maximum duration of delay to standard care or treatment of known efficacy
1 week
Treatment to be provided at the end of the study
Patients who do not respond to standard rTMS will be offered individualized targeting rTMS as part of their 
ongoing care, outside the NYSPI. No treatment is provided at NYSPI. 
Clinical Treatment Alternatives
Clinical treatment alternatives
There are non-drug and drug therapies available to treat depression. Depression is often initially treated with 
psychotherapy (talk therapy) and antidepressant medication administered together. Although antidepressants 
can be effective for some patients, they do not work for everybody. Additionally, antidepressants often 
result in unwanted side effects.
Many patients do not receive adequate benefit from antidepressant medication and/or cannot tolerate the 
side effects caused by them. For these patients, alternative treatments that involve the use of a medical 
device are available. These treatments include transcranial magnetic stimulation (TMS), electroconvulsive 
therapy (ECT) and vagus nerve stimulation (VNS).
 
Dr. Moreno will discuss all other alternative treatments for depression with patients before the second 
course of TMS in group 2, including antidepressant medications, psychotherapy, electroconvulsive therapy 
(ECT) and vagus nerve stimulation (VNS).
 
No treatment is provided at NYSPI.  
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
Participants could become anxious, bored or tired while participating in medical or psychiatric screening 
    
MRI
While there have been no reports of any harmful long-term effects caused by MRI magnets of the same or 
even higher strength as those used in this study, the long-term effects of being placed in a magnet are 
unknown. Although there are no risks associated with pregnancy, we will not scan anyone who is pregnant. 
Females in their childbearing years will be asked to take a pregnancy test for exclusion. Sometimes 
sensations such as tingling or twitching are experienced, which are caused by the magnetic field that can 
stimulate peripheral nerves. Exclusion criteria for the scan include pacemakers and other metallic implants, 
which would pose a risk to the subject if s/he were exposed to strong magnetic fields. It may be 
uncomfortable to lie motionless in the MRI camera and it may cause some subjects to feel anxious and 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 29 of 36
claustrophobic. Normal operation of the MR system produces loud noises, and foam earplugs will be 
provided to reduce the noise. Our staff will be available to provide support, reduce anxiety, optimize the 
comfort of the subject and remove the subject from the scanner if requested. There are no known long-term 
risks from magnetic resonance imaging studies. An acute risk of burns to the skin is presented by medicinal 
skin patches, and subjects will be asked to remove patches before entering the scanner. Short-term risks also 
include tissue heating from excessive systemically absorbed radiofrequency radiation and stimulation of 
peripheral nerves from rapidly changing magnetic fields. Both software and hardware protection schemes 
are present in the equipment to prevent excessive amounts or rates of change of systemically absorbed 
radiofrequency radiation. At 3T, short-term side effects include mild dizziness, nausea, and metallic taste.
These effects are due to movement within the magnetic field and are terminated when subjects cease head 
movement. The scanner to be used in this study (at NYSPI) is a non significant risk device.
 
NeuroStar NT TMS Therapy
Seizures: In clinical trials using the NeuroStar Therapy System, which included over 10,000 TMS 
treatments, no seizures were reported. The current device labeling warns that the expected and observed 
frequency and - occurrence of seizures is less than 1 in 30,000 treatments (<0.003%) and 1 in 1000 patients 
(<0.1%). Rare cases have reported the development of seizures during or immediately after transcranial 
magnetic stimulation (TMS). Having a seizure includes a potential effect on your future employability, 
insurability, and ability to drive. Should you experience a seizure that is related to magnetic stimulation, 
your doctor will provide you with a letter stating that the seizure was produced under experimental 
conditions and that there is no reason to expect another occurrence. Individuals who have a history of 
seizures or have been diagnosed with epilepsy will be excluded from this research study.
 
Muscle Twitching: You may feel twitches in the muscles of your face during the magnetic stimulation.
 
Headache: A mild headache can occur following TMS treatment that usually resolves soon after the 
procedure. The headaches may be from maintaining a fixed head position for the duration of the TMS 
treatment. We will try to reduce the risk of headache by assuring your comfort before and during the 
procedures.
Changes in hearing: The loud “click” produced by the TMS stimulator can cause temporary hearing changes 
following treatment. This is prevented by wearing soft foam earplugs during treatment.
 
Low blood pressure and feelings of nausea: If you take blood pressure medications you may have a low 
blood pressure while sitting restfully in the research chair. Some may also have a feeling of nausea. Eating 
and taking fluid before the session will help prevent these symptoms. If these symptoms occur, the session 
will be stopped and resumed only when the symptoms resolve.
 
Also, metal objects located close to the hand held TMS coil might move during magnetic stimulation. These 
items should be removed during treatment. Individuals with any metal implants will also be excluded from 
the research study.
All efforts will be made to minimize these risks by using only trained personnel who are experienced and 
skilled in using the device. Moreover, all TMS sessions will be performed in a medical setting with access 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 30 of 36
to a skilled medical team and life-support equipment. All TMS treatments will be implemented outside 
the NYSPI site.
 
NT TMS is an investigational treatment which is not approved by the FDA. A licensed MD assigned to the 
study at any of Dr. Perera's offices will meet with patients weekly and assess clinical worsening, 
suicidality, and intolerable side effects. No NT TMS will be implemented at the NYSPI site. If patients 
show a worsening of their general psychopathological condition, a clinical judgment after correspondent 
clinical evaluation will be made as to whether NT TMS treatments should be discontinued. If patients miss 
any three consecutive treatment sessions or any five treatment sessions, they will be dropped from the study, 
and after treatment recommendations they will be returned to routine clinical management under the 
supervision of Dr. Perera. 
TMS Neuronavigation System
There are no anticipated risks to you from the neuronavigator. Neuronavigation systems enable accurate 
planning, targeting and monitoring for brain stimulation studies using TMS. 
 
 
Describe procedures for minimizing risks
See above
Methods to Protect Confidentiality
Describe methods to protect confidentiality
All data (written and electronic) will be coded by number. A master list identifying subjects with codes will 
be kept under lock and key, separate from any research records or the computer database, with access 
restricted to research staff, to the extent permitted by law. Only staff directly involved in this project will 
have access to the master list linking subject names to code numbers. In the informed consent form, subjects 
are told that the information they provide and all findings of testing will be kept strictly confidential, with 
access limited to the research staff, and possibly state or federal regulatory personnel. Information about the 
patients' condition and treatment will be kept in a computer but the patients' names will not appear in this 
database. The information will only be linked to a code number assigned for the purposed of maintaining 
privacy. Only members of the research team will have access to the computer.
 
If a medical event occurs involving the NeuroStar TMS, Neuronetics, the manufacturer of the NeuroStar, 
may need to see confidential information as it relates to the event. 
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects  

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 31 of 36
Direct Benefits to Subjects
There are no direct benefits to participants.
 
Individualized targeting of rTMS for Non-responders to standard TMS approaches (Group 2) may improve 
treatment response.  
 
 
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
No
References
References
1.                 Chen J, Zhou C, Wu B, et al. Left versus right repetitive transcranial magnetic stimulation in treating 
major depression: a meta-analysis of randomised controlled trials. Psychiatry research Dec 30 
2013;210(3):1260-1264.
 
2.                 Fitzgerald PB, Hoy K, Gunewardene R, Slack C, Ibrahim S, Bailey M, Daskalakis ZJ. A randomized 
trial of unilateral and bilateral prefrontal cortex transcranial magnetic stimulation in treatment-resistant 
major depression. Psychological medicine Jun 2011;41(6):1187-1196.
 
3.                 Herrmann LL, Ebmeier KP. Factors modifying the efficacy of transcranial magnetic stimulation in 
the treatment of depression: a review. The Journal of clinical psychiatry Dec 2006;67(12):1870-1876.
 
4.                 Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic 
stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. 
Biological psychiatry Oct 1 2012;72(7):595-603.
 
5.                 Fox MD, Liu H, Pascual-Leone A. Identification of reproducible individualized targets for treatment 
of depression with TMS based on intrinsic connectivity. NeuroImage Feb 1 2013;66:151-160.
 
6.                 Vogt BA, Pandya DN. Cingulate cortex of the rhesus monkey: II. Cortical afferents. The Journal of 
comparative neurology Aug 8 1987;262(2):271-289.
 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 32 of 36
7.                 Petrides M, Pandya DN. Dorsolateral prefrontal cortex: comparative cytoarchitectonic analysis in 
the human and the macaque brain and corticocortical connection patterns. The European journal of 
neuroscience Mar 1999;11(3):1011-1036.
 
8.                 Lu MT, Preston JB, Strick PL. Interconnections between the prefrontal cortex and the premotor 
areas in the frontal lobe. The Journal of comparative neurology Mar 15 1994;341(3):375-392.
 
9.                 Badre D, D'Esposito M. Is the rostro-caudal axis of the frontal lobe hierarchical? Nature reviews 
Neuroscience Sep 2009;10(9):659-669.
 
10.
Selemon LD, Goldman-Rakic PS. Common cortical and subcortical targets of the dorsolateral 
prefrontal and posterior parietal cortices in the rhesus monkey: evidence for a distributed neural network 
subserving spatially guided behavior. The Journal of neuroscience: the official journal of the Society for 
Neuroscience Nov 1988;8(11):4049-4068.

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 33 of 36
11.                 Osuch EA, Ketter TA, Kimbrell TA, George MS, Benson BE, Willis MW, Herscovitch P, Post 
RM. Regional cerebral metabolism associated with anxiety symptoms in affective disorder patients. 
Biological psychiatry Nov 15 2000;48(10):1020-1023.
 
12.                 Bauer M, London ED, Rasgon N, et al. Supraphysiological doses of levothyroxine alter regional 
cerebral metabolism and improve mood in bipolar depression. Molecular psychiatry May 2005;10(5):456- 
469.
 
13.                 Dunn RT, Kimbrell TA, Ketter TA, Frye MA, Willis MW, Luckenbaugh DA, Post RM. Principal 
components of the Beck Depression Inventory and regional cerebral metabolism in unipolar and bipolar 
depression. Biological psychiatry Mar 1 2002;51(5):387-399.
 
14.                 Mayberg HS, Brannan SK, Tekell JL, Silva JA, Mahurin RK, McGinnis S, Jerabek PA. Regional 
metabolic effects of fluoxetine in major depression: serial changes and relationship to clinical response. 
Biological psychiatry Oct 15 2000;48(8):830-843.
 
15.                 Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C, Schwalb JM, 
Kennedy SH. Deep brain stimulation for treatment-resistant depression. Neuron Mar 3 2005;45(5):651-660.
 
16.                 Wu J, Buchsbaum MS, Gillin JC, et al. Prediction of antidepressant effects of sleep deprivation by 
metabolic rates in the ventral anterior cingulate and medial prefrontal cortex. The American journal of 
psychiatry Aug 1999;156(8):1149-1158.
 
17.                 Fitzgerald PB, Oxley TJ, Laird AR, Kulkarni J, Egan GF, Daskalakis ZJ. An analysis of functional 
neuroimaging studies of dorsolateral prefrontal cortical activity in depression. Psychiatry research Nov 22 
2006;148(1):33-45.
 
18.                 Greicius MD, Flores BH, Menon V, Glover GH, Solvason HB, Kenna H, Reiss AL, Schatzberg 
AF. Resting-state functional connectivity in major depression: abnormally increased contributions from 
subgenual cingulate cortex and thalamus. Biological psychiatry Sep 1 2007;62(5):429-437.
 
19.                 Drevets WC, Savitz J, Trimble M. The subgenual anterior cingulate cortex in mood disorders. CNS 
spectrums Aug 2008;13(8):663-681.
 
20.
Mayberg HS. Modulating dysfunctional limbic-cortical circuits in depression: towards development 
of brain-based algorithms for diagnosis and optimised treatment. British medical bulletin 2003;65:193-207.
 
21.
Kito S, Hasegawa T, Koga Y. Neuroanatomical correlates of therapeutic efficacy of low-frequency 
right prefrontal transcranial magnetic stimulation in treatment-resistant depression. Psychiatry and clinical 
neurosciences Mar 2011;65(2):175-182.
 
22.
Ferreri F, Pasqualetti P, Maatta S, et al. Human brain connectivity during single and paired pulse 
transcranial magnetic stimulation. NeuroImage Jan 1 2011;54(1):90-102.
 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 34 of 36
23.
Fox MD, Halko MA, Eldaief MC, Pascual-Leone A. Measuring and manipulating brain connectivity 
with resting state functional connectivity magnetic resonance imaging (fcMRI) and transcranial magnetic 
stimulation (TMS). NeuroImage Oct 1 2012;62(4):2232-2243.
 
24.
Ruff CC, Driver J, Bestmann S. Combining TMS and fMRI: from 'virtual lesions' to functional- 
network accounts of cognition. Cortex; a journal devoted to the study of the nervous system and behavior 
Oct 2009;45(9):1043-1049.
 
25.
Siebner HR, Bergmann TO, Bestmann S, et al. Consensus paper: combining transcranial stimulation 
with neuroimaging. Brain stimulation Apr 2009;2(2):58-80.
 
26.
Drevets WC, Price JL, Furey ML. Brain structural and functional abnormalities in mood disorders: 
implications for neurocircuitry models of depression. Brain structure & function Sep 2008;213(1-2):93-118.
 
27.
Takahashi S, Ukai S, Tsuji T, Kose A, Shoyama M, Yamamoto M, Okumura M, Shinosaki K. 
Cerebral blood flow in the subgenual anterior cingulate cortex and modulation of the mood-regulatory 
networks in a successful rTMS treatment for major depressive disorder. Neurocase 2013;19(3):262-267.
 
28.
Smith AJ, Blumenfeld H, Behar KL, Rothman DL, Shulman RG, Hyder F. Cerebral energetics and 
spiking frequency: the neurophysiological basis of fMRI. Proceedings of the National Academy of Sciences 
of the United States of America Aug 6 2002;99(16):10765-10770.
 
29.
DiNuzzo M, Gili T, Maraviglia B, Giove F. Modeling the contribution of neuron-astrocyte cross talk 
to slow blood oxygenation level-dependent signal oscillations. Journal of neurophysiology Dec 
2011;106(6):3010-3018.
 
30.
Logothetis NK. What we can do and what we cannot do with fMRI. Nature Jun 12 
2008;453(7197):869-878.
 
31.
Horn DI, Yu C, Steiner J, et al. Glutamatergic and resting-state functional connectivity correlates of 
severity in major depression - the role of pregenual anterior cingulate cortex and anterior insula. Frontiers in 
systems neuroscience 2010;4.
 
32.
Duncan NW, Enzi B, Wiebking C, Northoff G. Involvement of glutamate in rest-stimulus interaction 
between perigenual and supragenual anterior cingulate cortex: a combined fMRI-MRS study. Human brain 
mapping Dec 2011;32(12):2172-2182.
 
33.
Falkenberg LE, Westerhausen R, Specht K, Hugdahl K. Resting-state glutamate level in the anterior 
cingulate predicts blood-oxygen level-dependent response to cognitive control. Proceedings of the National 
Academy of Sciences of the United States of America Mar 27 2012;109(13):5069-5073.
 
34.
Northoff G, Walter M, Schulte RF, et al. GABA concentrations in the human anterior cingulate 
cortex predict negative BOLD responses in fMRI. Nature neuroscience Dec 2007;10(12):1515-1517.
 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 35 of 36
35.
Luborzewski A, Schubert F, Seifert F, et al. Metabolic alterations in the dorsolateral prefrontal cortex 
after treatment with high-frequency repetitive transcranial magnetic stimulation in patients with unipolar 
major depression. Journal of psychiatric research Oct 2007;41(7):606-615.
  
36.
Drevets WC, Bogers W, Raichle ME. Functional anatomical correlates of antidepressant drug 
treatment assessed using PET measures of regional glucose metabolism. European 
neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology Dec 
2002;12(6):527-544.
 
37.
Liotti M, Mayberg HS, McGinnis S, Brannan SL, Jerabek P. Unmasking disease-specific cerebral 
blood flow abnormalities: mood challenge in patients with remitted unipolar depression. The American 
journal of psychiatry Nov 2002;159(11):1830-1840.
  
38.
Pizzagalli DA, Oakes TR, Fox AS, et al. Functional but not structural subgenual prefrontal cortex 
abnormalities in melancholia. Molecular psychiatry Apr 2004;9(4):325, 393-405.
  
39.
Drevets WC, Price JL, Simpson JR, Jr., Todd RD, Reich T, Vannier M, Raichle ME. Subgenual 
prefrontal cortex abnormalities in mood disorders. Nature Apr 24 1997;386(6627):824-827.
 
40.
Drevets WC, Savitz J, Trimble M. The subgenual anterior cingulate cortex in mood disorders. CNS 
spectrums Aug 2008;13(8):663-681.
 

Protocol Summary Form
7159
Moreno-Ortega, Marta
Page 36 of 36
 
Uploads
Upload the entire grant application(s)
Upload copy(ies) of unbolded Consent Form(s)
dep_fMRI_ICF_Group_1&2.pdf
Upload copy(ies) of bolded Consent Form(s)
dep_fMRI_ICF_Group_1&2.pdf
Upload copy(ies) of the HIPAA form
'HIPPA.pdf
Upload any additional documents that may be related to this study
MRI_letters_revised .pdf

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
	





'(+&(','-(++-"")-"('"',+!

	



	
,.+("& "' "'-"'-,'+ ("' (+)+,,"('

		
		,+-(+'(9+- 4!

	
		,(%.&"'"/+,"-240(+$--,2!"-+"
',-"-.-


"--%",$'(0'(.-'"-!+!(0)+,,"('-,-!+"'0!"%)()%+"'+,-"' ,--;"66
'(-("' '2-!"' <'(+0!-+"'!' ,+,.%-+(&+"/"' +-+-&'-6+,$"' 2(.-(!/
'
(2(.++"'(+2(.,-+-2(.++-+-&'-,,,"(',4,0%%,-+2(.+"%2-+-&'-
,,,"(',+(&)%-6!",0"%%('0"-!,)"%$"'(
4%%.'-"('%
;
<40!"!'
&,.+!(0-"/2(.++"'",0!"%2(.++,-"' "'-!&!"'60"%%,$2(.-((,(+ +%,,(
2(.+"/'"-+(&2(.+-+-&'-(+'(-60"%%.,-!-0(%%--(--+.'+,-'!(0
)+,,"(''--!+"'4(-!0"-!'0"-!(.-)+,,"/,2&)-(&"&)+(/&'-6
#'$#"%"&%"$ %"$*"'&"'*'!$%&!)&&%&'*!("(%+!&!*"'
)!&&"#$&#&-

	
(. + "'  ,$ -( )+-"")- "' -!", ,-.2 ., 2(. !/ %- -( +"/ +)-"-"/
-+',+'"%& '-",-"&.%-"(';+<,&',-(-+-2(.+)+,,"('6!"%+!,&(',-+-
'-")+,,'--,4"-!,'.'+.-"%"3-(-4,-!+",0"/+"-2"')-"'-,7+,)(',,-(
-+-&'-5,(&)()%0!(+"/!/&+$"&)+(/&'-"'-!,2&)-(&,(-!"+)+,,"('
0!"%(-!+,+"/'('"-6
-",.'%+0!2-!",!))',6	(0/+40$'(0-!-('-(+0!"!-,
-+-&'-+,)(',",-!.+2(0!+-!("%",)%.+"' -!-+-&'-,,,"(',6"+',
"'+"',-+.-.+'.'-"('-0')()%&$"-"&)(+-'--(!/!,,,"('7,%(-"('-+ -
,)""%%2(+-!"'"/".%6'02-!",'!"/",2.,"' & '-"+,(''"& "' ;
<40!"!
",02(-$"' )"-.+,(-!+"'6"-!"& ,((')+,('7,+"'4,)"")+-(-!,-'++
-+-&'-+ "(''%(-4'-!","'(+&-"(''.,-(',.+.+-("%)%&'-'
-+ -"' 6
'-!",,-.2400"%%1&"'&-!(,20!"!
'.,-("'"/".%"3+-+-&'-,
2"'-"2"' '()-"&%,-"&.%-"(',"-(+!)+,('40!"!0%"/&2!/-!)(-'-"%-("'+,
-!"2(-!-+-&'-6,)+-(-!",,-.22(.0"%%,$-((&-(-!	"$	.&$"'#
" 	 !!&$&"$!"/-(!/'
,'(2(.++"')+8)(,-
-+-&'-,6

	
+-"")-"('"'-!",+,+!,-.2",/(%.'-+26
2(."'(--()+-"")-4(+"2(.%-+"-(
,-() )+-"")-"' 4 2(. 0"%% '(- %(, '2 '"-, -( 0!"! 2(. + (-!+0", '-"-%6  ","(' '(- -(
)+-"")-(+0"-!+02(.+)+-"")-"('0"%%'(--2(.+.++'-(+.-.+-+-&'---!0(+$--
,2!"-+"
',-"-.-(+(%.&"'"/+,"-26


IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9





!",",'(--+-&'-,-.26
'(+&-"('"' (%%-",(++,+!).+)(,,('%2'",-(%+'
&(+(.-!(0)+,,"('-,-!+"'4'(-(.-2(.6
-",'(-',,+2-()+-"")-"'-!",+,+!
,-.2-(!/'
4'-!
(',)+-(-!",,-.2",'(--!,&,('('(+&"%).+)(,,6


-
2(.0"%%('%2(&-(!/+"('/+,-"('0"-!+6(+'(-(/+"22(.+%" "%-(
)+-"")- "' -!", ,-.2 ' -( !/  %"'"%8'.+(( '"-"/ /%.-"(' 0"-!  &&+ ( (.+ ,-6 "
" #&*"'$	%!%*"')" &"	"$	-"&$& !&%) # !&&&
	%&-

/%.-"(''+'"' 
-+2(.!/," '-!",(','-(+&-!-2(.0'--()+-"")-"'-!",,-.242(.0"%%/%.-
-(,"2(.+%" "%-()+-"")-'(&)%--!,-.2)+(.+,6(.0"%%&-0"-!&&+((.+
,-4'2(.0"%%,$(.-2(.+.++'-'),-)!2,"%'&'-%!%-!6(.0"%%,$-("%%(.-
,(&(+&,+*.,-"' ,"&( +)!""'(+&-"('40!-!'2(..,-((+-"'-,$,4'-(,""-",
,(+2(.-(!/'
40!"!,$,2(.(.-'2&-%2(.&2!/(+!/!"'2(.+(26
2(.+
0(&'(!"%+"'  42(.0"%%,$-()+(/".+"',&)%(+)+ ''2-,-6!",,!(.%-$
(.-!%'!(.+6
-",)(,,"%-!-4-+(&)%-"' -!/%.-"('42(.&" !-'(-%" "%-(,-.2
)+-"")'-6
,(42(.0"%%'(-(&)%-'2.+-!+-,-"' (+,,,,&'-,6-+-!/%.-"('",(&)%-
'2(.+&%" "%-()+-"")-4-!+0"%%-0(-,-"' ,,,"(',40!"!0"%%(.+('"+'-2,5
(',,,"('-((&)%-)+9-+-&'-
'('-((-!)(,-9-+-&'-
6!,+,+""'
-"%%(06
'-!-.2
-"'++2,-"('4('",-"&%"'(1-%20!-)+(.+,2(.0"%%.'+ ('
0!'-!,)+(.+,0"%%(.++,+"6

.'-"('% '-",(''
& "' ;
<
(.0"%%,$-(!/'
,'(+2(.+"+,--+-&'-'0"-!"'02,-+2(.+
%,--+-&'-6!
.,,,-+(' & '-""%,'+"(0/,-(-$)"-.+,(2(.++"'6
'-!",,-.24
2(.++"'0"%%-!('%2(2)+--!-","& 6!,'0+)+(+&"' ",%%.'-"('%& '-"
+,(''"& "' ,';
<6
-","+'-+(&+ .%+
"'-!--!"& ,0 -+(&-!,'0"%%
,!(0!(0-"/2(.++"'",0!"%2(.+-+,-;"66'(-("' '2-!"' <6(+2(.4-!",0"%%%"$'2(-!+
-2)(
2(.&2!/!"'-!),-6(+ "''"' -!"& "' )+(.+400"%%-+&"'-!-2(.
('(-!/)&$+(+'2.',&-%%""&)%'-,4,.!,''.+2,&%")4+-"""%!+-/%/4(+
+-"'---((,6(.&.,-%,("'(+&.,"2(.!/'2&-%(#-,"',"2(.+(24,"',(&(-!,
(#-,&2)+/'-2(.+(&!/"' '
6(.0"%%-!',$-(+&(/'2&""'%)-!,('2(.+
,$"'''2&-%(+& '-"3(#-,;,.!,$2,4!"',4#0%+24+-"'+,4&"-"(')-!,4!"+)"',4
+"-+,<-!-2(.&2!/('2(.6

"'/(%/,%2"' ('-%-!-,%","'-(%+ & '-,!)%"$2%"'+4'2(.0"%%-!'
,$-(,-20$'%"&(-"('%,,('-!-%(+-!.+-"('(-!,'6(.0"%%'(-%'2-!"' 4.-
2(.0"%%!+$'($"' '(",6!",",'(+&%,(.')+(.2-!
,''+'(,'(-"'"--!-
'2-!"' ",0+(' 6(.0"%% "/'(&+)%. ,-(+.-!",'(",6(.0"%%'(-%-(,(.-(-!

&!"'4.-2(.0"%%%-(!+.,'!+"2(.0",!-(,2'2-!"' 6!
-!'""''
(-!+,-0"%%"'-!('-+(%+((&'1-9((+-!0!(%-"&6!,'0"%%%,-(.-('!(.+6(.&2
,-()-!,'-'2-"&6
!"%
,',+,(&-"&,('(+%"'"%).+)(,,4-!$"'(
,'2(.0"%%!/,)+-(
-!", ,-.2 ", (+ +,+! ).+)(,, ('%26 !", &', -!- -! ,', + '(- ," ' -( )+(/" %"'"%

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
"'(+&-"('-!-&" !-!%).%-(2(.(+2(.+(-(+4'-!2&2'(-,!(0)+(%&,-!-0(.%'(+&%%2
(.'"''
(++-(/%.-,)""&"%)+(%&6
-",%"$%2-!--!
,'0"%%'(-!/
-!*.%"-2(-!(,('(+%"'"%).+)(,,6!+,.%-,(2(.+,'0"%%&"'-"'"''%-+('"%%2
,.+-,&	"$	6'",,,"%,(%%2-(-!&&+,(-!+,+!-&6	(0/+40"-!"'
&('-!(-!
4-!,'0"%%+2'.+(+"(%( ",-(+/"'('2(/"(.,"++ .%+"-",
+*."+"'  (%%(09.)6 (.4 (+  )!2,""' 0!(& 2(. &2 !((,4 0"%%  "'(+& ('%2 0!' ," '""'-
'(+&%"-",+--6
2(.0",!40'%,("'(+&2(."-!+0+'((/"(.,"'"' ,6"/'-!
'-.+(-!,'4-!,'("'"' (,'(-&'-!-('",'(-)+,'-6!
,,,"(',!(.%-$
A!(.+6

%"'"%,,,,&'-,
(.0"%%,$-(!/',,,,&'-,,,"('(+2(.+"+,--+-&'-'0"-!"'02,
-+2(.+%,--+-&'-4,!.%(+-!,&22(.(&-(-!	"$	-(!/2(.+
,'6
!-,-"' ,,,"('0"%%"'%.*.,-"(',+ +"' 2(.+)+,,"/,2&)-(&,'-,$,+%--(&&(+2'
(-!+( '"-"/)"%"-",6!+,.%-,(2(.+-,-"' ,,,"('0"%%&"'-"'"''%-+('"%%2,.+
-,-
'",,,"%,(%%2-(-!&&+,(-!+,+!-&6!-,-"' ,,,"(',!(.%-$
(.--0(!(.+,'0"%%"&)%&'--+2(.+
,'6

-.2
-"'++2
2A5(.0"%%(&-(-!
)+"(+-(2(.+"+,--+-&'--(&-0"-!+6(+'('
&&+(!++,+!,--((&)%-,+'"' ,,,"('-(/+"2%" ""%"-24'-(!/2(.+%"'"%
,,,,&'-,,,,"('6(.0"%%(&-(-!	"$	-(!/2(.+
,'6
(.0"%%"+,-,+'4-!'&&+(-!+,+!,-0"%%&-0"-!2(."'-!-,-"' +((&
(+2(.+%"'"%,,,,&'-,,,,"('4'0!'-!%"'"%,,,,&'-,,,,"('"'",!,42(.0"%%!/2(.+

,'6!'-"+/","-,!(.%-$C-(E!(.+,)'"' ('-!
,"-6
2-0(5(.0"%%(&-(-!
-+2(.+-+-&'-,+(&)%--(&-0"-!+6(+'(
'&&+(!++,+!,--(!/2(.+%"'"%,,,,&'-,,,,"(''
,'6+(.+,0"%%
(%%(0,&+ "&',"'2A6






/%.-"('',,,,&'-,
!+ + '( '-"")- +",$, -( 2(. +(& -! %"'"% ' &"% /%.-"(',6 (. &2 "' -!
"'-+/"0,(.-2(.+)!2,"%(+),2!(%( "%!%-!.),--"' 4.-'(&(+,(-!'2(.0(.%.'+ (,
)+-(2(.++(.-"'!%-!+6
2(.(42(.'"'(--(',0+,)""*.,-"(',4,$(++$4(+
,-()-!"'-+/"06




!%(' 9-+&-,("' )%"'& '-(-!",,-+' -!;C,%<+.'$'(0'4.-2(.,!(.%
0+-!--!+!/''(+)(+-,('2"%%%(' 9-+&-,.,2& '-,(-!,&(+/'
!" !+,-+' -!4"-!+!+(+%,0!+6%,(4%-!(. !-!++'($'(0'+",$,,,("-0"-!)+ ''24
00"%%'(-,',(&('0!(",)+ ''-6!+(+42(.,!(.%.'+,-'-!-"2(.+0(&'"'2(.+
!"%9+"' 2+,4)+ ''2-,-"' 0"%%.,-(,,.+-!-2(.+'(-)+ ''-6
(&)()%!/+)(+-,',-"(',.+"' -!
,'4,.!,>-"' %"' >(+>-0"-!"' >;(+4/+2
++%24)"'.%,',-"('<40!"!+.,2!' ,"'-!& '-""%-!-',-"&.%-'+/,"'2(.+

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
(26
2(.1)+"',',-"(','%-!--!,+.'(&(+-%42(.'-%%-!-!'(%( ",-4'
!(+,!0"%%,-()-!,'"&&"-%26,"('%%24,(&)()%1)+"''+/(.,',,(+%.,-+()!("
%"' ,.-(-!,''+=,,&%%,)6
2(.'(.'-+'2",(&(+-42(.'-%%-!-!'(%( ",-4
'!(+,!0"%%,-()-!,'"&&"-%26,)"--!,1)+"',4'(('!,/+!,',-"(',+(&
-!,''"' -!-"'(-,-(),,((',-!,''"' ,-())6
1)-(+)&$+,',(&-2),(&-%%""&)%'-,40$'(0('(!%-!!3++(&-!

,'6!
,'",'(-)"'.%4.-%2"' ,-"%%('-!,''"' -%&2,%" !-%2.'(&(+-%6



	
(.+'(-1)--('"-+(&)+-"")-"('"'-!",,-.26





'2"'(+&-"('(-"'.+"' -!",,-.2'"'-""0"-!2(.0"%%+&"'('"'-"%6"'$#$(&
!"$ &"!"$	"''%"$'&'$$%$%&'%"$%&$'&&"!"&$!(%&&"$"$'&'$
$%$%&'%+)&"'&!&$%-
(+,0"%%/"%%-(+,+!,-4'-(+%4--4'
',-"-.-"('%+ .%-(+2)+,(''%
;0!(&2+/"0+(+,,)+-(+(.-"'."-,<6%%"'(+&-"('0"%%,-(+"'%($"%,'0"%%$)-
('"'-"%-(-!1-'-)+&"--2%06
%%-;0+"--''%-+('"<0"%%(6&,-+%",-&-!"' -!,.#-0"-!(,0"%%$)-
.'+%($'$240!"!",,)+-+(&'2+,+!+(+,(+-!(&).-+-,6,,",+,-+"-
-(+,+!,-4-(-!1-'-)+&"--2%06'%2,-"+-%2"'/(%/"'-!",)+(#-0"%%!/,,-(
-!&,-+%",-%"'$"' 2(.+'&-(('.&+,6(.+'&'(-!+)+,('%"'-"2"' "'(+&-"('0"%%
,-(+"'"%,'"''%-+('"%%2,.+-,--!0(+$--,2!"-+"
',-"-.-6
(.+ 
 0"%%  "'-+)+- ' -! +,.%-, 0"%%  ,!+ 0"-! 2(. (+  )!2,""' 0!( 2(. &2
," '-6(.+
+)(+-0"%%&"'-"',)+-(-!;%-+('"%%2,.+<%"'"%-,--!0
(+$--,2!"-+"
',-"-.-%(' 0"-!2(.+'&'0"%%,,"%-(&&+,(-!+,+!-&6
(.+),2!"-+"" '(,",0"%%'(-)+-(-!+)(+-6
(.,!(.%$'(0-!-"0%+'-!-2(.(+,(&('%,",-!+-'0"-!,+"(.,!+&4,.!,
!"%(+'%+%2)+,('"' .,4-!"'/,-" -(+,0(.%-$-"(',-()+(--2(.'(-!+,4"'%."' 
+)(+-"' -!,,"-.-"(',-()+()+.-!(+"-",6
!*$(!&$%$$%'&%)!"&%"%&"#$&#!&%-



!+",'((,--()+-"")-"'-!",,-.26(.0"%%'(-)"-()+-"")-"'-!",,-.26




+%+ .%-"(',+*."+-!-0"'(+&)+-"")'-,(.-(.+"',-"-.-"('=,)(%"20"-!+ +-(
(&)',-"('')2&'-(+-+-&'-(+,+!9+%-"'#.+",6
2(.%"/-!-2(.!/,.,-"'
'"'#.+2,+,.%-()+-"")-"' "'+,+!,-.242(.&2('---!+"'")%
'/,-" -(+4+6+-
(+'(9+- 4-;IAD<BAH9GCAA,(-!-2(.'+/"0-!&--+'"'-"2-!&"%+,(.+,-!-
&2/"%%-(2(.6

' , ( "'#.+24 0 (+$ -- ,2!"-+" 
',-"-.- 0"%% )+(/" ,!(+- -+& &+ '2 &"%
-+-&'-40!"!!,'-+&"'-(',,+220(+$--,2!"-+"
',-"-.-=,(-(+,4'
0!"!",0"-!"'-!)"%"-2(0(+$--,2!"-+"
',-"-.--()+(/"6
'"-"('400"%%)+(/"
,,",-'"'++' "' (%%(0.)+"',.!"',-',6

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
0 (+$ -- ,2!"-+" 
',-"-.- ' ,+! (.'-"(' (+ '-% 	2 "' ( '(- )+(/"
(&)',-"('(+)2&'-(+-+-&'-(+,+!+%-"'#.+",6	(0/+42(.,!(.%0+-!-2(.
('(- "/.)2(.+% %+" !--(,$,.!(&)',-"('-!+(. !-!(.+-2)+-"")-"' "'-!",+,+!6



+6(+'(9+- 4(+!++,+!-&40"%%',0+4-(-!,-(-!"+"%"-24'2*.,-"(',-!-2(.
&2!/'(0(+"'-!.-.+(.--!+,+!)+(.+,(+(.-2(.++,)(',-(-!)+(.+,6(.
&2%%+6(+'(9+- -;IAD<BAH9GCAA6(.0"%% "/'-!())(+-.'"-2-(",.,,"'('"''2
*.,-"(',2(.&2!/6(.0"%% "/'()2(-!",(','-(+&-($)6


2(.!/'2*.,-"(',(.-2(.++" !-,,+,+!)+-"")'-40'--()+(/"$4(+!/
(&)%"'-42(.&2%%-!

',-"-.-"('%/"0(+;
<6;'
",(&&"---!-)+(--,-!
+" !-,(!.&',.#-,"'+,+!,-.",<6(.&2%%-!
"-;FDF<GGD9GAEE.+"' + .%+("
!(.+,6




IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9





%,!$-!",(1"2(.0(.%%"$-("'(+&(2(.+
+,.%-,4/'"-!+0+'((/"(.,
"++ .%+"-",--


 2!$"' -!",(14
 +-!--!+,+!+,&2('--&"'-!.-.+-(-+&"'"
&
"'-+,-"')+-"")-"' "'.+-!+,-.",6+-"")-"('"''2,.,*.'-,-.2",()-"('%6




/(%.'-+"%2 +-()+-"")-"'-!+,+!,-.2,+"(/6



" '-.+()+-"")'-:::::::::::::::::::::::::::::
-:::::::::::::::::: 



+"'-'&()+-"")'-::::::::::::::::::::::::::








!/",.,,-!)+()(,+,+!0"-!-!",)+-"")'-"'%."' -!+",$,4'"-,4'%-+'-"/,-(
)+-"")-"(' ;"'%."'  -! %-+'-"/ ( '(- )+-"")-"'  "' -! +,+!<6 ! )+-"")'- !, ! '
())(+-.'"-2-(,$*.,-"(','4"'&2()"'"('4",)%(+%2(','-"' -()+-"")-"'-!",+,+!6



" '-.+:::::::::::::::::::::::::::::
-::::::::::::::::::





+"'-'&::::::::::::::::::::::::::



IRB #7159: Neuroimaging in patients undergoing TMS for depression 

 
  
 
Subject Name:   
___ 
  
 
 
 
Thank you for participating in our study. We remind you that the MRI scan of the brain that we performed was 
for research purposes only. It would not show problems that would be picked up by a more specialized 
medical MRI scan ordered by your doctor for a specific medical problem. The scan provides little clinical 
information other than the presence or absence of certain irregularities. In fact, the absence of a finding does 
not mean that one is not present. 
 
 
The review of your scan was done by a doctor trained in brain MRI interpretation (a neuroradiologist) who 
found no obvious irregularities during the reading of the MRI. If you would like to request that a copy of 
the report be sent to your physician, please call Dr. Moreno-Ortega at 914-218-7311. 
  
 
Please contact us if you have any questions. 
  
 
 
 
 
 
Sincerely, 
 
 
 
 
Dr. Moreno-Ortega 
 
 

IRB #7159: Neuroimaging in patients undergoing TMS for depression 

 
 
 
Subject Name: ______________________ 
 
 
Thank you for participating in our study. We remind you that the MRI scan of the brain that we 
performed was for research purposes only. It may not show problems that would be picked up by a more 
specialized medical MRI scan ordered by your doctor for a specific medical problem. The scan provides little 
clinical information other than the presence or absence of certain irregularities. In fact, the absence of a 
finding does not mean that one is not present. 
 
As we mentioned in our recent telephone conversation, the review of your scan by a doctor trained in 
brain MRI interpretation (a neuroradiologist) showed an irregularity, and we recommend that you follow up 
with your physician as soon as possible to determine if any further action is necessary. If you would like to 
request that a copy of the report be sent to your physician, please call Dr. Moreno-Ortega at 914-218-7311.  
 
Please contact us if you have any questions. 
 
 
 
Sincerely, 
 
 
Dr. Moreno-Ortega 

 

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
	





'(+&(','-(++-"")-"('"',+!

	



	.+("& "' "'-"'-,'+ ("' (+)+,,"('


	
+-(+'(9+- 4!

	
(%.&"'"/+,"-240(+$--,2!"-+"
',-"-.-


"--%",$'(0'(.-'"-!+!(0)+,,"('-,-!+"'0!"%)()%+"'+,-"' ,--;"66
'(-("' '2-!"' <'(+0!-+"'!' ,+,.%-+(&+"/"' +-+-&'-6+,$"' 2(.-(!/
'
(2(.++"'(+2(.,-+-2(.++-+-&'-,,,"(',4,0%%,-+2(.+"%2-+-&'-
,,,"(',+(&)%-6!",0"%%('0"-!,)"%$"'(
4%%.'-"('%
;
<40!"!'
&,.+!(0-"/2(.++"'",0!"%2(.++,-"' "'-!&!"'60"%%,$2(.-((,(+ +%,,(
2(.+"/'"-+(&2(.+-+-&'-(+'(-60"%%.,-!-0(%%--(--+.'+,-'!(0
)+,,"(''--!+"'4(-!0"-!'0"-!(.-)+,,"/,2&)-(&"&)+(/&'-6
!).+)(,(-!",(+&",(+2(.-(.%%2.'+,-'0!--!,-.2"'/(%/,4'-!'""2(.
0'--()+-"")-6

	
(. + "'  ,$ -( )+-"")- "' -!", ,-.2 ., 2(. !/ %- -( +"/ +)-"-"/
-+',+'"%& '-",-"&.%-"(';+<,&',-(-+-2(.+)+,,"('6!"%+!,&(',-+-
'-")+,,'--,4"-!,'.'+.-"%"3-(-4,-!+",0"/+"-2"')-"'-,7+,)(',,-(
-+-&'-5,(&)()%0!(+"/!/&+$"&)+(/&'-"'-!,2&)-(&,(-!"+)+,,"('
0!"%(-!+,+"/'('"-6
-",.'%+0!2-!",!))',6	(0/+40$'(0-!-('-(+0!"!-,
-+-&'-+,)(',",-!.+2(0!+-!("%",)%.+"' -!-+-&'-,,,"(',6"+',
"'+"',-+.-.+'.'-"('-0')()%&$"-"&)(+-'--(!/!,,,"('7,%(-"('-+ -
,)""%%2(+-!"'"/".%6'02-!",'!"/",2.,"' & '-"+,(''"& "' ;
<40!"!
",02(-$"' )"-.+,(-!+"'6"-!"& ,((')+,('7,+"'4,)"")+-(-!,-'++
-+-&'-+ "(''%(-4'-!","'(+&-"(''.,-(',.+.+-("%)%&'-'
-+ -"' 6
'-!",,-.2400"%%1&"'&-!(,20!"!
'.,-("'"/".%"3+-+-&'-,
2"'-"2"' '()-"&%,-"&.%-"(',"-(+!)+,('40!"!0%"/&2!/-!)(-'-"%-("'+,
-!"2(-!-+-&'-6,)+-(-!",,-.22(.0"%%,$-((&-(-!
(+
;"-" +(.)
"(&"%
& "' '-+-"%%(+'%%"%(%% <-(!/'
,'(2(.++"')+8)(,-
-+-&'-,6

	
+-"")-"('"'-!",+,+!,-.2",/(%.'-+26
2(."'(--()+-"")-4(+"2(.%-+"-(
,-() )+-"")-"' 4 2(. 0"%% '(- %(, '2 '"-, -( 0!"! 2(. + (-!+0", '-"-%6  ","(' '(- -(
)+-"")-(+0"-!+02(.+)+-"")-"('0"%%'(--2(.+.++'-(+.-.+-+-&'---!0(+$--
,2!"-+"
',-"-.-(+(%.&"'"/+,"-26


IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9





!",",'(--+-&'-,-.26
'(+&-"('"' (%%-",(++,+!).+)(,,('%2'",-(%+'
&(+(.-!(0)+,,"('-,-!+"'4'(-(.-2(.6
-",'(-',,+2-()+-"")-"'-!",+,+!
,-.2-(!/'
4'-!
(',)+-(-!",,-.2",'(--!,&,('('(+&"%).+)(,,6


-
2(.0"%%('%2(&-(!/+"('/+,-"('0"-!+6(+'(-(/+"22(.+%" "%-(
)+-"")- "' -!", ,-.2 ' -( !/  %"'"%8'.+(( '"-"/ /%.-"(' 0"-!  &&+ ( (.+ ,-6 (
(&)%-2(.+
,',2(.0"%%(&-(
(+
6(-+-&'-,0"%%"&)%&'---!

,"-6

/%.-"(''+'"' 
-+2(.!/," '-!",(','-(+&-!-2(.0'--()+-"")-"'-!",,-.242(.0"%%/%.-
-(,"2(.+%" "%-()+-"")-'(&)%--!,-.2)+(.+,6(.0"%%&-0"-!&&+((.+
,-4'2(.0"%%,$(.-2(.+.++'-'),-)!2,"%'&'-%!%-!6(.0"%%,$-("%%(.-
,(&(+&,+*.,-"' ,"&( +)!""'(+&-"('40!-!'2(..,-((+-"'-,$,4'-(,""-",
,(+2(.-(!/'
40!"!,$,2(.(.-'2&-%2(.&2!/(+!/!"'2(.+(26
2(.+
0(&'(!"%+"'  42(.0"%%,$-()+(/".+"',&)%(+)+ ''2-,-6!",,!(.%-$
(.-!%'!(.+6
-",)(,,"%-!-4-+(&)%-"' -!/%.-"('42(.&" !-'(-%" "%-(,-.2
)+-"")'-6
,(42(.0"%%'(-(&)%-'2.+-!+-,-"' (+,,,,&'-,6-+-!/%.-"('",(&)%-
'2(.+&%" "%-()+-"")-4-!+0"%%-0(-,-"' ,,,"(',40!"!0"%%(.+('"+'-2,5
(',,,"('-((&)%-)+9-+-&'-
'('-((-!)(,-9-+-&'-
6!,+,+""'
-"%%(06
'-!-.2
-"'++2,-"('4('",-"&%"'(1-%20!-)+(.+,2(.0"%%.'+ ('
0!'-!,)+(.+,0"%%(.++,+"6

.'-"('% '-",(''
& "' ;
<
(.0"%%,$-(!/'
,'(+2(.+"+,--+-&'-'0"-!"'02,-+2(.+
%,--+-&'-6!
.,,,-+(' & '-""%,'+"(0/,-(-$)"-.+,(2(.++"'6
'-!",,-.24
2(.++"'0"%%-!('%2(2)+--!-","& 6!,'0+)+(+&"' ",%%.'-"('%& '-"
+,(''"& "' ,';
<6
-","+'-+(&+ .%+
"'-!--!"& ,0 -+(&-!,'0"%%
,!(0!(0-"/2(.++"'",0!"%2(.+-+,-;"66'(-("' '2-!"' <6(+2(.4-!",0"%%%"$'2(-!+
-2)(
2(.&2!/!"'-!),-6(+ "''"' -!"& "' )+(.+400"%%-+&"'-!-2(.
('(-!/)&$+(+'2.',&-%%""&)%'-,4,.!,''.+2,&%")4+-"""%!+-/%/4(+
+-"'---((,6(.&.,-%,("'(+&.,"2(.!/'2&-%(#-,"',"2(.+(24,"',(&(-!,
(#-,&2)+/'-2(.+(&!/"' '
6(.0"%%-!',$-(+&(/'2&""'%)-!,('2(.+
,$"'''2&-%(+& '-"3(#-,;,.!,$2,4!"',4#0%+24+-"'+,4&"-"(')-!,4!"+)"',4
+"-+,<-!-2(.&2!/('2(.6

"'/(%/,%2"' ('-%-!-,%","'-(%+ & '-,!)%"$2%"'+4'2(.0"%%-!'
,$-(,-20$'%"&(-"('%,,('-!-%(+-!.+-"('(-!,'6(.0"%%'(-%'2-!"' 4.-
2(.0"%%!+$'($"' '(",6!",",'(+&%,(.')+(.2-!
,''+'(,'(-"'"--!-
'2-!"' ",0+(' 6(.0"%% "/'(&+)%. ,-(+.-!",'(",6(.0"%%'(-%-(,(.-(-!

&!"'4.-2(.0"%%%-(!+.,'!+"2(.0",!-(,2'2-!"' 6!
-!'""''
(-!+,-0"%%"'-!('-+(%+((&'1-9((+-!0!(%-"&6!,'0"%%%,-(.-('!(.+6(.&2
,-()-!,'-'2-"&6
!"%
,',+,(&-"&,('(+%"'"%).+)(,,4-!$"'(
,'2(.0"%%!/,)+-(
-!", ,-.2 ", (+ +,+! ).+)(,, ('%26 !", &', -!- -! ,', + '(- ," ' -( )+(/" %"'"%

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
"'(+&-"('-!-&" !-!%).%-(2(.(+2(.+(-(+4'-!2&2'(-,!(0)+(%&,-!-0(.%'(+&%%2
(.'"''
(++-(/%.-,)""&"%)+(%&6
-",%"$%2-!--!
,'0"%%'(-!/
-!*.%"-2(-!(,('(+%"'"%).+)(,,6!+,.%-,(2(.+,'0"%%&"'-"'"''%-+('"%%2
,.+-,-
(+
6'",,,"%,(%%2-(-!&&+,(-!+,+!-&6	(0/+40"-!"'
&('-!(-!
4-!,'0"%%+2'.+(+"(%( ",-(+/"'('2(/"(.,"++ .%+"-",
+*."+"'  (%%(09.)6 (.4 (+  )!2,""' 0!(& 2(. &2 !((,4 0"%%  "'(+& ('%2 0!' ," '""'-
'(+&%"-",+--6
2(.0",!40'%,("'(+&2(."-!+0+'((/"(.,"'"' ,6"/'-!
'-.+(-!,'4-!,'("'"' (,'(-&'-!-('",'(-)+,'-6!
,,,"(',!(.%-$
A!(.+6

%"'"%,,,,&'-,
(.0"%%,$-(!/',,,,&'-,,,"('(+2(.+"+,--+-&'-'0"-!"'02,
-+2(.+%,--+-&'-4,!.%(+-!,&22(.(&-(-!
(+
-(!/2(.+
,'6
!-,-"' ,,,"('0"%%"'%.*.,-"(',+ +"' 2(.+)+,,"/,2&)-(&,'-,$,+%--(&&(+2'
(-!+( '"-"/)"%"-",6!+,.%-,(2(.+-,-"' ,,,"('0"%%&"'-"'"''%-+('"%%2,.+
-,-
'",,,"%,(%%2-(-!&&+,(-!+,+!-&6!-,-"' ,,,"(',!(.%-$
(.--0(!(.+,'0"%%"&)%&'--+2(.+
,'6

-.2
-"'++2
2A5(.0"%%(&-(-!
)+"(+-(2(.+"+,--+-&'--(&-0"-!+6(+'('
&&+(!++,+!,--((&)%-,+'"' ,,,"('-(/+"2%" ""%"-24'-(!/2(.+%"'"%
,,,,&'-,,,,"('6(.0"%%(&-(-!
(+
-(!/2(.+
,'6
(.0"%%"+,-,+'4-!'&&+(-!+,+!,-0"%%&-0"-!2(."'-!-,-"' +((&
(+2(.+%"'"%,,,,&'-,,,,"('4'0!'-!%"'"%,,,,&'-,,,,"('"'",!,42(.0"%%!/2(.+

,'6!'-"+/","-,!(.%-$C-(E!(.+,)'"' ('-!
,"-6
2-0(5(.0"%%(&-(-!
-+2(.+-+-&'-,+(&)%--(&-0"-!+6(+'(
'&&+(!++,+!,--(!/2(.+%"'"%,,,,&'-,,,,"(''
,'6+(.+,0"%%
(%%(0,&+ "&',"'2A6






/%.-"('',,,,&'-,
!+ + '( '-"")- +",$, -( 2(. +(& -! %"'"% ' &"% /%.-"(',6 (. &2 "' -!
"'-+/"0,(.-2(.+)!2,"%(+),2!(%( "%!%-!.),--"' 4.-'(&(+,(-!'2(.0(.%.'+ (,
)+-(2(.++(.-"'!%-!+6
2(.(42(.'"'(--(',0+,)""*.,-"(',4,$(++$4(+
,-()-!"'-+/"06




!%(' 9-+&-,("' )%"'& '-(-!",,-+' -!;C,%<+.'$'(0'4.-2(.,!(.%
0+-!--!+!/''(+)(+-,('2"%%%(' 9-+&-,.,2& '-,(-!,&(+/'
!" !+,-+' -!4"-!+!+(+%,0!+6%,(4%-!(. !-!++'($'(0'+",$,,,("-0"-!)+ ''24
00"%%'(-,',(&('0!(",)+ ''-6!+(+42(.,!(.%.'+,-'-!-"2(.+0(&'"'2(.+
!"%9+"' 2+,4)+ ''2-,-"' 0"%%.,-(,,.+-!-2(.+'(-)+ ''-6
(&)()%!/+)(+-,',-"(',.+"' -!
,'4,.!,>-"' %"' >(+>-0"-!"' >;(+4/+2
++%24)"'.%,',-"('<40!"!+.,2!' ,"'-!& '-""%-!-',-"&.%-'+/,"'2(.+

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
(26
2(.1)+"',',-"(','%-!--!,+.'(&(+-%42(.'-%%-!-!'(%( ",-4'
!(+,!0"%%,-()-!,'"&&"-%26,"('%%24,(&)()%1)+"''+/(.,',,(+%.,-+()!("
%"' ,.-(-!,''+=,,&%%,)6
2(.'(.'-+'2",(&(+-42(.'-%%-!-!'(%( ",-4
'!(+,!0"%%,-()-!,'"&&"-%26,)"--!,1)+"',4'(('!,/+!,',-"(',+(&
-!,''"' -!-"'(-,-(),,((',-!,''"' ,-())6
1)-(+)&$+,',(&-2),(&-%%""&)%'-,40$'(0('(!%-!!3++(&-!

,'6!
,'",'(-)"'.%4.-%2"' ,-"%%('-!,''"' -%&2,%" !-%2.'(&(+-%6



	
(.+'(-1)--('"-+(&)+-"")-"('"'-!",,-.26





'2"'(+&-"('(-"'.+"' -!",,-.2'"'-""0"-!2(.0"%%+&"'('"'-"%6(.+)+"/-
"'(+&-"('(+
(.%.,(+.-.++,+!,-.",(+",-+".--('(-!+"'/,-" -(+(+.-.+
+,+!,-.",40"-!(.-"'-""+,6
(+,0"%%/"%%-(+,+!,-4'-(+%4--4'
',-"-.-"('%+ .%-(+2)+,(''%
;0!(&2+/"0+(+,,)+-(+(.-"'."-,<6%%"'(+&-"('0"%%,-(+"'%($"%,'0"%%$)-
('"'-"%-(-!1-'-)+&"--2%06
%%-;0+"--''%-+('"<0"%%(6&,-+%",-&-!"' -!,.#-0"-!(,0"%%$)-
.'+%($'$240!"!",,)+-+(&'2+,+!+(+,(+-!(&).-+-,6,,",+,-+"-
-(+,+!,-4-(-!1-'-)+&"--2%06'%2,-"+-%2"'/(%/"'-!",)+(#-0"%%!/,,-(
-!&,-+%",-%"'$"' 2(.+'&-(('.&+,6(.+'&'(-!+)+,('%"'-"2"' "'(+&-"('0"%%
,-(+"'"%,'"''%-+('"%%2,.+-,--!0(+$--,2!"-+"
',-"-.-6
(.+ 
 0"%%  "'-+)+- ' -! +,.%-, 0"%%  ,!+ 0"-! 2(. (+  )!2,""' 0!( 2(. &2
," '-6(.+
+)(+-0"%%&"'-"',)+-(-!;%-+('"%%2,.+<%"'"%-,--!0
(+$--,2!"-+"
',-"-.-%(' 0"-!2(.+'&'0"%%,,"%-(&&+,(-!+,+!-&6
(.+),2!"-+"" '(,",0"%%'(-)+-(-!+)(+-6
(.,!(.%$'(0-!-"0%+'-!-2(.(+,(&('%,",-!+-'0"-!,+"(.,!+&4,.!,
!"%(+'%+%2)+,('"' .,4-!"'/,-" -(+,0(.%-$-"(',-()+(--2(.'(-!+,4"'%."' 
+)(+-"' -!,,"-.-"(',-()+()+.-!(+"-",6
%"'"%%2+%/'-+,+!+,.%-,0"%%'(-",%(,-()+-"")'-,6



!+",'((,--()+-"")-"'-!",,-.26(.0"%%'(-)"-()+-"")-"'-!",,-.26




+%+ .%-"(',+*."+-!-0"'(+&)+-"")'-,(.-(.+"',-"-.-"('=,)(%"20"-!+ +-(
(&)',-"('')2&'-(+-+-&'-(+,+!9+%-"'#.+",6
2(.%"/-!-2(.!/,.,-"'
'"'#.+2,+,.%-()+-"")-"' "'+,+!,-.242(.&2('---!+"'")%
'/,-" -(+4+6+-
(+'(9+- 4-;IAD<BAH9GCAA,(-!-2(.'+/"0-!&--+'"'-"2-!&"%+,(.+,-!-
&2/"%%-(2(.6

' , ( "'#.+24 0 (+$ -- ,2!"-+" 
',-"-.- 0"%% )+(/" ,!(+- -+& &+ '2 &"%
-+-&'-40!"!!,'-+&"'-(',,+220(+$--,2!"-+"
',-"-.-=,(-(+,4'
0!"!",0"-!"'-!)"%"-2(0(+$--,2!"-+"
',-"-.--()+(/"6
'"-"('400"%%)+(/"
,,",-'"'++' "' (%%(0.)+"',.!"',-',6

IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9
0 (+$ -- ,2!"-+" 
',-"-.- ' ,+! (.'-"(' (+ '-% 	2 "' ( '(- )+(/"
(&)',-"('(+)2&'-(+-+-&'-(+,+!+%-"'#.+",6	(0/+42(.,!(.%0+-!-2(.
('(- "/.)2(.+% %+" !--(,$,.!(&)',-"('-!+(. !-!(.+-2)+-"")-"' "'-!",+,+!6



+6(+'(9+- 4(+!++,+!-&40"%%',0+4-(-!,-(-!"+"%"-24'2*.,-"(',-!-2(.
&2!/'(0(+"'-!.-.+(.--!+,+!)+(.+,(+(.-2(.++,)(',-(-!)+(.+,6(.
&2%%+6(+'(9+- -;IAD<BAH9GCAA6(.0"%% "/'-!())(+-.'"-2-(",.,,"'('"''2
*.,-"(',2(.&2!/6(.0"%% "/'()2(-!",(','-(+&-($)6


2(.!/'2*.,-"(',(.-2(.++" !-,,+,+!)+-"")'-40'--()+(/"$4(+!/
(&)%"'-42(.&2%%-!

',-"-.-"('%/"0(+;
<6;'
",(&&"---!-)+(--,-!
+" !-,(!.&',.#-,"'+,+!,-.",<6(.&2%%-!
"-;FDF<GGD9GAEE.+"' + .%+("
!(.+,6




IRB # 7159 
Page 1 of 5 
+,"('5F8G8AI



9





%,!$-!",(1"2(.0(.%%"$-("'(+&(2(.+
+,.%-,4/'"-!+0+'((/"(.,
"++ .%+"-",--


 2!$"' -!",(14
 +-!--!+,+!+,&2('--&"'-!.-.+-(-+&"'"
&
"'-+,-"')+-"")-"' "'.+-!+,-.",6+-"")-"('"''2,.,*.'-,-.2",()-"('%6




/(%.'-+"%2 +-()+-"")-"'-!+,+!,-.2,+"(/6



" '-.+()+-"")'-:::::::::::::::::::::::::::::
-:::::::::::::::::: 



+"'-'&()+-"")'-::::::::::::::::::::::::::








!/",.,,-!)+()(,+,+!0"-!-!",)+-"")'-"'%."' -!+",$,4'"-,4'%-+'-"/,-(
)+-"")-"(' ;"'%."'  -! %-+'-"/ ( '(- )+-"")-"'  "' -! +,+!<6 ! )+-"")'- !, ! '
())(+-.'"-2-(,$*.,-"(','4"'&2()"'"('4",)%(+%2(','-"' -()+-"")-"'-!",+,+!6



" '-.+:::::::::::::::::::::::::::::
-::::::::::::::::::





+"'-'&::::::::::::::::::::::::::



#&!9;1)(#&.(#"#&'&ϰ2ϭϰ2:ϰ
&!##
"'#!"##$#/
0
$#!(##"!""#!#$!"!#$'

!#$!*

!%"##!*
#$'*
!!"!!"$"!"!'##!#/,#!#-0$#'$"!##
%"#$'/#,"!-0)#&!##
"'#!"##$#/
0"! $!##'$!$#!(#+$!
#&#&%$"##"#$"""#!#$#'$""!&*
x
+#&(('-(&"'(()(78/-#)&#(#&'"#(& (&$&#*&'/"-/"
x
&"$ "*'((#&"'5&'(7(#(&3'&&'482'&&'!-" )'(#/(+#&
((#"(  (78/'&#)"(#"#&"( -"/"278/"# )!"*&'(-78/
$&#*')'('$&(#('()-/"
x
WƌŽǀŝĚĞƌƐŽĨƐĞƌǀŝĐĞƐĨŽƌƚŚĞZĞƐĞĂƌĐŚĂƚh͕Ez^W/ĂŶĚͬŽƌZ&D,͕ƐƵĐŚĂƐDZ/ŽƌWd͕Žƌ"(& &"
#&(#&'
;E	8/Ĩ"("(#"'"(#&!+
2+
#!###'$"ͬŽƌ""!#""!$"*
  "#&!(#"#  ()&"('&'(# (#-#)"("#&!#"'"(#&!2 
 ("#&!(#""-#)& " &'&&#&+" )'(&') ('#$-' ,!'/! "
$'-(&'(#&-/ #&(#&-#&"#'(('('/#& ("#&!(#"& ("(#$&() &#"(#"(('& ((#
('&2 
(#" "#&!(#"!-" )1
;2
#!#"#%'""#*
'&&'"(&'(((#  #+"#&".(#"'"*# *+((''&1
$#"'#&#('&/
"('"('"#"(&(#&'7(#(&/3$#"'#&480"
$&'"((*'#&) (#&-"#*&"!"("'/"'(()(#" &*+#&'/&$&'"((*'#('&&'
"(&"'(()(#"'(#( * "(#&&-#)((&&'$#"' ('& ((#(#")(#(&'&2
&*( #&(#&'"#(&$&'#"'"#&".(#"'((" -.-#)& ("#&!(#""#""(#"+(
(''()-
(&7! -!!&'#&'""(#(&'/'()-)'/#)('"'(28$-1
<2
-*"$&!''#"(#& '-#)& ("#&!(#"''&#*/-#))"&'("((-#)& (
"#&!(#"!-' #'(#"*) '#&"(('+&"#(&%)&(##!$ -+((& "'(($&*- +'
+#*&"()'"' #')&#$&'#"  ("#&!(#"-2'!"'((#"-#)& (
7159
Marta Moreno-Ortega, PHD
Neuroimaging in patients undergoing TMS for depression
✔
✔
✔
Contemporary Care; Mount Sinai; Citigroup Biomedical Imaging Center at Weill Cornell Medical College
✔
✔

#&!9;1)(#&.(#"#&'&ϰ2ϭ2:ϰ
"#&!(#"'"' #'(#(&$&(-+#'"#(*(##  #+(' +'722/&)#!$"-#&($#"'#&
#('&8/(!-"# #"&$&#(()"&(#&"( -"
+&%)&!"(')('')((#(
(&!'#(#"'"(#&!"!-')((##(&'((#&& $&*- +'#&&) (#"'2
3+

"###*
x
#)#"#(*(#'"(')(#&.(#"#&!/)(-#)#"#(/-#)ŵĂǇ"#( (#$&($("('()-#&
&*'()-& (&2#)!-"-#)&!"("-(!"#&"-&'#"2-#)#'#/-#)!-"#
 #"&  #+(#$&($("('()-2-#)+(&+(')(#&.(#"(&'&'("($#"'#&/('
''$#"'#&&'&/!-'(  )'#&' #' ("#&!(#"#"("""(-""#&!(#"(- &-*
#  (#)(-#)'"(#!"("(&  (-#(&'&2"-&%)'((#+(&+(')(#&.(#"
!)'(!"+&("(#7"(&"!"#"(("#&!(#" #+81
x
 ('&'#"#"/-#)!-"#(  #+(#&*+( ("#&!(#""-#)& " &'&
&#&(('"&(#&#  (-2"('&'&'"#!$ (-#)!-  #+(#'
('"#&!(#"2('"#&-#)&&/-#)& ("#&!(#"+  *"(#-#)#&-#)&#(#&2
4+
"$#!(#"#%#+
5+
$&%'#"!#!'$%"#+
!##$"""$!#!#$#""!%*
666666666666666666666666666666666666666666666666666666666666666
"()&#&ƚŝĐŝƉĂŶƚ5
 $&'"((* 
(
66666666666666666666666666666666666666
&"(!#&ƚŝĐŝƉĂŶƚ
66666666666666666666666666666666666666
ZĞůĂƚŝŽŶƐŚŝƉŽĨ>ĞŐĂůZĞƉƌĞƐĞŶƚĂƚŝǀĞƚŽWĂƌƚŝĐŝƉĂŶƚ;ŝĨĂƉƉůŝĐĂďůĞͿ
""'$!'$!!!"##%###"###"&*
%!%'#
.	#
!%'
!#"+
Marta Moreno-Ortega. 1051 Riverside Dr., Unit 21. New York, NY 10032. 
(p): (914)218-7311     (f): (646) 774-5428