Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
Phase: PHASE1
Conditions: Depression, Major Depressive Episode, Bipolar Disorder
Sponsor: New York State Psychiatric Institute

Signed copy on file at IRB 
 
             v.9/2013 
New York State Psychiatric Institute 
Institutional Review Board 
 
 
July 11, 2017 
 
To: 
 
Dr. Stefan Rowny 
From:  
Dr. Edward Nunes, Co-Chairman, IRB 
 
 
Dr. Laurence Greenhill, Co-Chairman, IRB 
 
 
 
 
 
Subject: 
APPROVAL NOTICE: CONTINUATION APPROVAL 
 
 
 
 
 
         EXPEDITED PER 45CFR46.110(b)(1)(f)(8)(c) 
 
 
  
 
 
Your protocol #6427  entitled:    IMPROVING OUTCOMES IN GERIATRIC DEPRESSION: 
MAGNETIC SEIZURE THERAPY  ACAR/PSF version date 7/5/17 and consent forms (version) 
have been approved by the New York State Psychiatric Institute - Columbia University Department 
of Psychiatry Institutional Review Board from JULY 25, 2017 TO JULY 24, 2018.   
Consent requirements: 
     
    X Not applicable: (RECRUITMENT COMPLETED. DATA BEING ANALYZED) 
 
     45CFR46.116(d) waiver or alteration of consent for the telephone screen.   
 
     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 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 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 or events 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.    
 
CC:  RFMH 
 
EN/LG/ls 

Protocol Summary Form
6427
Rowny, Stefan
Page 1 of 28
Protocol Title:
Improving Outcomes in Geriatric 
Depression: Magnetic Seizure Therapy
Protocol Number:
6427
First Approval:
12/27/2011
Expiration Date:
07/24/2017
Version Date:
07/11/2017
Clinic:
Brain and Behavior Clinic
Contact Principal Investigator:
Stefan Rowny, MD
Email: Rownyst@nyspi.columbia.edu
Telephone: 646-774-5417
Co-Investigator(s):
Linda Fitzsimmons, RN
Ramin Parsey, MD
Joan Prudic, MD
Peter Bulow, MD
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 without 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? 
Brain Stimulation
Unaffiliated Personnel
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.

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Rowny, Stefan
Page 2 of 28
n/a
Application for Continuation of Research
Status
Current Status of Study: 
All research interventions were completed. Only data analysis 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 have completed all research procedures for subjects enrolled in this study and are just beginning data 
analysis. 
 
In conclusion, eighteen medication resistant patients with MDE have completed convulsive treatment (ECT 
or MST) following medication washout. From baseline, the mean drop in HRSD24 was 19.3 points. Fifteen 
patients met remission criteria (reduction of 60% in HRSD24 scores from baseline or a HRSD24 score less 
than or equal to 10). One patient was randomized into treatment but after discussion of risks and benefits 
within the anesthesiology team chose to seek a traditional medication treatment and therefore withdrew 
from the study. One patient demonstrated a 45.16% reduction in depressive symptoms, and two other 
patients were terminated from the study to a clinical treatment modality because their response did not meed 
the study's criteria for progress.
 
Across the board, participants experienced minimal side effects from their treatment and all had fully 
recovered, completing the standard post-treatment reorientation battery. Patients' Mini-Mental State Exam 
scores remained stable from baseline to assessment immediately following the treatment course and six 
months post-treatment, indicating a lack of significant impairment in cognition on this measure.
 
In this reporting period there were no anticipated or unanticipated adverse effects to report, and there were 
no deviations from the protocol.  
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?

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Rowny, Stefan
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Yes
Summary
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
20
Total number of participants enrolled to date
18
Number of participants who have completed the study to date 
18
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
Sample Demographics
Specify population
Older adults aged 55-90 years
Total number of participants enrolled from this population to date 
18
Gender, Racial and Ethnic Breakdown 
58.8% Female
42.2% Male
 
88.8% Caucasian
5.6% African-American
5.6% Asian 

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Rowny, Stefan
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Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
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
   Psychiatric Assessment
   Neuropsychological Evaluation
   Collection of Biological Specimens
   Medication-Free Period or Treatment Washout
   Device Trial
   Use of Investigational Drug or Device
Population
Indicate which of the following populations will be included in this research
   Adults over 50
   Inpatients
Research Support/Funding
Will an existing internal account be used to support the project?
Yes
Describe internal account
RFMH (K23)
Is the project externally funded or is external funding planned?
No
Study Location
Indicate if the research is/will be conducted at any of the following
   NYSPI

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Rowny, Stefan
Page 5 of 28
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
Unlike any other treatment, electroconvulsive therapy (ECT) is highly effective for severe 
depression and both, the depressed and manic phases of bipolar disorder. This is noteworthy 
since effective treatment of bipolar depression remains an unsolved clinical problem. Why, then, 
does a treatment that is based in its ability to elicit a seizure, like ECT, not play a more prominent 
role in the treatment of mood disorder? ECT is underutilized in large part because of its adverse 
cognitive effects, some of which can be persistent. Magnetic seizure therapy (MST) is under 
development as a means of improving the side effect profile of ECT so that more patients may 
benefit without suffering significant detrimental effects on cognition. Magnetic fields offer markedly 
better control over the spatial distribution and the extent of stimulation, factors that largely 
determine the efficacy and side effects of ECT. Our preliminary studies demonstrated that MST 
can induce seizures with substantially fewer cognitive side effects than ECT, and provided the first 
open-label evidence of antidepressant efficacy. This new protocol is a 5-year randomized 
controlled trial of 30 patients to test the efficacy of MST in severe depression (additional 8 open 
treatments will be performed as necessary outside of the randomized controlled trial, to integrate 
new devices into the protocol). The results of this study will help elucidate neurobiological 
mechanisms of treatment response to two types of convulsive treatment and help to determine 
whether MST will proceed to the next phase of clinical development leading to eventual FDA-
approval of this novel therapeutic intervention. If our hypotheses are supported, MST will provide 
a well-tolerated, effective treatment for patients with the most disabling and life-threatening mood 
disorders. 
Background, Significance and Rationale
Background, Significance and Rationale
This is a randomized controlled trial of Magnetic Seizure Therapy (MST) in the treatment of 
depression. In addition to the randomized, controlled trial recruitment with a sample target of 30 
volunteers, the treatment and data collection may be expanded by up to 4 patients in each arm to 
allow for new equipment integration into the protocol.  Phase 1 is a double-masked, randomized, 
controlled trial that contrasts the efficacy and safety of MST and ECT. Eligible patients will be 
randomized 1:1 to each. Safety and adverse events will be assessed using standardized scales 
as well as pre- and post-treatment testing of cognition (see Table 1 for list of measures).  Phase 1 
provides a randomized comparison of MST versus ECT.  Since MST involves general anesthesia 
(which carries risk of its own), a true placebo condition would not have been ethically permissible. 
Phase 2, the follow up, will provide a descriptive within-subject characterization of longer-term 
outcomes (i.e., long-term durability of benefit and/or persistence of side effects).

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We have been testing the safety of MST in the nonhuman primate over the past 15 years.  
This work has demonstrated the safety of MST in comparison to electroconvulsive shock (ECS) 
using cognitive, physiological, neuroanatomical, neuropathological, and stereological 
assessments.  Our results show that the electric field induced by MST is less intense and more 
confined to superficial cortex than ECS. MST-induced seizures show less robust ictal expression, 
less postictal suppression. Most importantly to this protocol, there is less generalization to 
hippocampus and deeper brain structures. There was less robust serum prolactin surge and less 
immediate post-stimulus bradycardia.  These marked physiological differences are consistent with 
MST having less of an impact than ECS on temporal lobe and diencephalic structures, as 
hypothesized, and with less impact on parasympathetic outflow that should lower the risk of 
cardiac complications. We found that ECS, but not MST, induces the sprouting of mossy fiber in 
aberrant locations of the dentate gyrus.  Lack of physiological and structural changes in the 
hippocampus with MST may relate to its superior cognitive profile.  Indeed, our nonhuman primate 
model of the amnestic side effects of ECT revealed that monkeys were more accurate and faster 
following MST as compared to ECS.
            We now have 12 years of experience performing MST in human patients with depression.  
To date, approximately 160 patients have received MST worldwide (about 1/3 of these were 
treated at NYSPI).  This work has shown that human MST is feasible, well-tolerated, has fewer 
acute cognitive side effects than ECT, and shows evidence of antidepressant activity in an open 
trial.  Our clinical work guided the development of a higher output device (maximal frequency 100 
Hz) that was needed to keep pace with treatment-induced increases in seizure threshold and to 
broaden the available dosage range of the device. Our prior human work with the original MST 
device mostly involved triggering seizures from the motor strip, since this area has a lower seizure 
threshold than prefrontal cortex.  Even so, there was evidence of antidepressant activity in an 
open setting, with an average drop in Hamilton scores by 49% after an average of 9 treatments. 
Our most recent study yielded preliminary data suggesting that MST is safe and effective in the 
geriatric population. In this most recent, two-center study comparing ECT with MST at Columbia 
University and University of Texas South Western (the former now transferred to Duke University), 
15 patients over 55 years-old, received MST and tolerated it well.  There were no serious adverse 
events to date in this geriatric (or any other) sample and the study is now over 75% complete. 
Device and coil performance during the seizure induction sessions have been within the expected 
parameters, with no cases of excessive heating. Seizure threshold titrations have been 
successfully performed. The speed of reorientation immediately following the MST session was 
recorded. The average time to regain full orientation following the MST session was 385 ± 162 
seconds.  All of these patients also received ECT in the past.  We therefore selected the ECT 
treatment closest in time to the MST session and compared recovery time with this matched ECT 
session.  The average recovery time with ECT in these patients was 1148 ± 97 seconds, which is 
nearly 4-fold longer than recovery following MST.  Paired t-test revealed that recovery time post 
ECT was significantly longer than with MST (t(5)=7.4, p<0.0007).  Results from these first cases 
were accepted for presentation at the 2007 annual meeting of the Society of Biological 
Psychiatry.This protocol is essentially the same as that of Dr. Lisanby’s MST-3 (2007-2010 funded 
by Stanley Foundation) study mentioned above at NYSPI, but with a narrowed focus to population 
over 55 years-old.  

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Page 7 of 28
Outside of the United States, at least twenty patients with depression have now been 
treated with the same devices that the PI of this proposed study had gained expertise during the 
last 4 years of his work with Dr. Lisanby, before her NYSPI IRB-approved studies were moved to 
Duke University. The foreign academic centers involved in the development of MST as a novel 
therapy for depression, exist in UK, Germany, and Australia, where this treatment was given as 
part of IRB-approved protocols in Cardiff and Edinburgh, UK, as well as in Bonn and Berlin, 
Germany, and Melbourne, Australia.Treatments were well tolerated.  Anesthesia was identical to 
the standard used at these centers for clinical ECT.  
Specific Aims and Hypotheses
Specific Aims and Hypotheses
The goal of this project is to develop MST as a treatment for severe mood disorder for the elderly 
with fewer cognitive side effects than ECT, the most effective treatment for severe depression. 
Unlike ECT, MST can initiate seizures in superficial cortex, while limiting impact on deeper medial 
temporal structures and thereby resulting in less cognitive side effects. Results from previous trials 
in the general population sample, support the safety of MST and provide open-label evidence of 
antidepressant action. The specific aims and hypotheses are:
 AIM 1.
To evaluate the feasibility, tolerability, and efficacy of MST in elderly patients with a major 
depressive episode, who are randomly assigned to receive an acute course of MST or ECT. We 
hypothesize:
1a. MST will elicit seizures of at least 20 second duration recorded via electroencephalography 
(EEG) and motor expression in a cuffed limb.
1b. MST will show less cognitive side effects, less tachycardia and less post-stimulus bradycardia 
than ECT.
1c. MST will show antidepressant efficacy as indicated by a significant drop in depression scores 
as measured by Hamilton Depression Rating Scale (HRSD). This primary outcome will be 
compared between the MST and ECT groups with respect to response and remission.
 AIM 2.
To contrast the neurophysiological effects of MST and ECT in geriatric depression. We 
hypothesize:
2a. MST will show lower total ictal power and less post-ictal suppression than ECT as measured 
by quantitative scalp EEG.

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Rowny, Stefan
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2b. MST will show a differential topographical pattern relative to ECT as measured by 64-channel 
scalp EEG, with less generalization to the temporal lobe.
 
Description of Subject Population
Sample #1
Specify subject population
geriatric volunteers with depression 
Number of completers required to accomplish study aims
20
Projected number of subjects who will be enrolled to obtain required number of completers
30
Age range of subject population
55-90
Gender, Racial and Ethnic Breakdown
Gender: 53% Female, 46% Male.
Racial and Ethinic: 87.5% Caucasian, 6.3% African-America, and 6.3% Asian
Description of subject population
Adults 55-90 with severe depression.
Recruitment Procedures
Describe settings where recruitment will occur
Patients are referred by private physicians and by clinical services at NYSPI and other psychiatric 
facilities. Capacity to consent will be assessed by a member of the treatment team who is not an 
investigator on this study (such as the inpatient attending psychiatrist or the unit director).  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.

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How and by whom will subjects be approached and/or recruited? 
In addition to the previously implemented strategies, we intend to accelerate our recruitment in the 
final stages of the project through the following ways.
 
First, Dr. Prudic’s expiring study #6599—“Cognitive Training for Memory Deficits Associated With 
Electroconvulsive Therapy” will end recruitment in July 2015. Dr. Prudic is a co-investigator on this 
#6427 protocol and her robust referrals will significantly augment our enrollment. 
Second, a new RA is assigned to weekly checking and reposting of flyers and clinic brochures in 
the NYSPI building; this activity has already yielded positive results as the currently treated study 
volunteer was referred to us by the Geriatric Division clinic. 
Third, this RA together with the PI of the study will conduct daily phone calls to the acquainted 
attending colleagues at the Presbyterian Hospital’s CPEP, as needed, for potential study 
candidates who may be interested in clinical research of depression. It is also important to note 
that in discussions with the current mentor to the PI of this training K23 grant, Dr. Javitt, as well as 
the program official at NIMH, it was concluded that the sample size may be reduced without 
adversely affecting the study goals. Additionally, the PI is going to apply for a no-cost extension 
for the project. The latter extension was discussed and welcomed by the program official. 
How will the study be advertised/publicized? 
We have a flyer posted within NYSPI. In addition, we have contacted most of Manhattan based 
senior citizen's community centers and discussed leaving flyers to be regularly posted after their 
institutional approval, once we obtain our ACAR stamp for the flyer used in this continuation 
submission. 
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT01869374
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes
Describe concurrent research involvement

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Rowny, Stefan
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Participants from this study may also volunteer to participate in Protocol #6942 - Functional 
Connectivity and Resting State Changes Following Brain Stimulation: Effects Of Convulsive 
Therapy.
 
Concurrent involvement in study #6942 will require participants to undergo approximately 1.5 
hours baseline MRI scanning session prior to undergoing a series of acute convulsive therapy 
treatments and again, post-treatment MRI scan within one week of his/her last convulsive therapy 
treatment. During these two scan sessions standard anatomical and resting state functional MRI 
data will be collected as fully described in the Specific Aims and Hypotheses of that protocol.
 
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Adults 55-90 with severe depression
Create or insert table to describe the inclusion criteria and methods to ascertain them
     INCLUSION CRITERIA:                              METHOD OF ASCERTAINMENT
 
1. Age 55-90
Self-report
2. Clinical diagnosis of major 
depressive episode, in the context of 
unipolar or bipolar disorder
Structured Clinical Interview for 
Diagnosis 
(SCID-IV)
3. Willing and capable to provide informed 
consent
Physician evaluation
4. Convulsive therapy clinically indicated
Physician evaluation
5. Hamilton Rating Scale for Depression 
(HRSD24)20
HRSD24
6. Mini Mental State Exam (MMSE) >24
MMSE
7. For outpatients: responsible adult 
living with  patient
Self-report
 
 
 
Create or insert table to describe the exclusion criteria and methods to ascertain them
 EXCLUSION CRITERIA:                            METHOD OF ASCERTAINMENT
 

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1. Current unstable or serious medical 
condition, or any comorbid medical 
condition that substantially increases 
the risks of ECT (such as acute 
myocardial infarction, space occupying 
brain lesion or other cause of increased 
intracranial pressure, unstable 
aneurysm or vascular malformation, 
poorly controlled diabetes mellitus, 
carcinoma, renal failure, hepatic failure)
Physical evaluation (physical 
and neurological 
examination, EKG, blood and 
urine analysis)
2. History of neurological disorder, 
epilepsy, stroke, brain surgery, metal in 
the head, history of known structural 
brain lesion
Physician evaluation (TASS, 
medical history, and 
neurological examination)
3. Presence of devices that may be 
affected by MST (pacemaker, 
medication pump, cochlear implant, 
implanted brain stimulator, or vagus 
nerve stimulator implanted)
Physician evaluation (TASS, 
medical history)
4. History of head trauma with loss of 
consciousness for greater than 5 
minutes
Physician evaluation (medical 
history)
5. History of schizophrenia, 
schizoaffective disorder, or 
rapid cycling bipolar disorder
Structured Clinical Interview for 
Diagnosis
(SCID-IV)
6. History of substance abuse or 
dependence in past 3 months
SCID-IV, urine toxicology screen
7. History of ECT in the past 6 
months and/or failure to respond 
to an adequate trial of ECT 
lifetime
Physician evaluation (history) and 
ATHF
8. Presence of intracardiac lines
Physician evaluation (TASS, 
medical history)
 
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
Waiver or alteration of consent

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Rowny, Stefan
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No
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?
No
Describe procedures used to obtain consent during the screening process 
Potential patients referred to protocol #6427 are screened in the Brain Behavior Clinic under the 
umbrella protocol for our division's stimulation research screenings, protocol #6987 Evaluation for 
Brain Stimulation Treatment Research in the Brain Behavior Clinic.
Once admitted to 5S inpatient unit, the prospective volunteers will have a choice of signing the 
consent or not, after they have had an opportunity to have their questions about the study 
answered, and prior to any research evaluations or procedures. Should they choose not to 
participate in the study, they will receive clinical treatment only and no research procedures will be 
performed.
Describe Study Consent Procedures
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
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Berman, Joshua, MD
Prudic, Joan, MD
Rowny, Stefan, MD
Type in the name(s) not found in the above list
n/a 

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Rowny, Stefan
Page 13 of 28
Independent Assessment of Capacity
You have indicated that your study involves subjects who MAY LACK capacity to consent.
Does this study require an independent assessment of capacity?
Yes
Methods/procedures for capacity assessment
An attending psychiatrist on the inpatient unit at NYSPI will perform an independent capacity 
assessment and appropriately document in "Capacity to Consent Addendum" at the end of the 
ICF as quoted below.
 
"Capacity to Consent Addendum Protocol # ______
I have examined _________________________ on ______________ for the purpose of determining 
whether he/she is capable of understanding the purpose, nature, risks, benefits and alternatives (including 
non-participation) of the research, making a decision about participation, and understanding that the 
decision about participation in the research will involve no penalty or loss of benefits to which the patient is 
otherwise entitled, for Dr. Stefan Rowny’s research project “Magnetic Seizure Therapy for the Treatment of 
Major Severe Mood Disorder”. On the basis of this examination I have arrived at the conclusion that:
______ A. This patient has this capacity at this time.
______ B. There is a question about this patient’s capacity at this time.
______ C. This patient clearly lacks this capacity.
SIGNATURE                                                           DATE                                
                              Member of Treatment Team (M.D. or Ph.D.)
Print Name                                                                 
                              Member of Treatment Team (not a co-Investigator) "
Study Procedures
Describe the procedures required for this study
Informed Consent, Screening, and Medical Management
            Patients referred for convulsive therapy will be asked to sign a written informed consent. 
Standard pre-ECT workup will be performed, including medical history, physical exam, blood 
work, urine analysis/toxicology, chest x-ray, and medical clearance in accordance with the NYSPI 
Policy and Procedure Manual for ECT.  Also, in accordance with the Policy and Procedure Manual 

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Rowny, Stefan
Page 14 of 28
for ECT, patients may be admitted to the study as outpatients, on the condition that they have 
responsible adult available to provide direct support and to oversee treatment adherence. Patients 
desiring outpatient treatment and qualified for such under inclusion/exclusion criteria will be 
admitted and undergo at least 3 treatments as inpatients. They will be cleared by the clinical team 
before they are discharged to outpatient therapy.
Psychotropic Medication Washout
To determine efficacy in the absence of ancillary treatment, all patients will be washed out 
from psychotropic medications (except for PRN lorazepam up to 3 mg/day) for 5 days prior to 
treatment following admission to the inpatient unit at NYSPI. There will be no outpatient taper of 
medications by the research team. Patients may, if clinically indicated, make changes to their 
medication regimen prior to hospitalization only under their outpatient provider’s orders and that 
provider’s subsequent supervision. While the half-life of some medications will be longer, the 
severity of depression of patients referred for ECT necessitates a shorter washout period for 
clinical reasons. Patients will be monitored on the inpatient unit during the washout period via 
clinical interviews. The taper schedule will be tailored to each patient according to their individual 
medications and clinical status. Medications for medical conditions will be administered as 
clinically indicated and as ordered by the patient’s treatment team or the research team. As is 
standard practice in the NYSPI ECT service, and as recommended by the APA Task Force Report 
on ECT, benzodiazepines are withheld for 10 hours prior to the treatment.  
Motor Threshold (MT)
MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 
µV in peak to peak amplitude) in a target muscle in 5 out of 10 trials using single pulse TMS 
administered to the contralateral primary motor cortex.  MT is the standard in the field for 
determining the intensity of subconvulsive repetitive transcranial magnetic stimulation (rTMS) for 
each individual to reduce seizure risk.  However, data on its relationship with magnetic seizure 
threshold are limited.  MT will be determined in each subject at his/her first and last treatment 
sessions.  EMG responses will be displayed on a portable digital oscilloscope for rapid MT 
determination (approximately 5 minutes).  
Anesthesia and Monitoring
MST will be performed under general anesthesia of the type used in standard clinical ECT.  
Anesthesia will be administered by anesthesiologists with specific training and experience in ECT. 
Atropine (0.4 mg i.v.) will be given two minutes prior to anesthesia induction. Standard anesthetic 
will be used as determined most appropriate by the anesthesiology team, as used in clinical ECT 
practice and succinylcholine (0.75-1.0 mg/kg) will be used as the intravenous muscle relaxant 
agent. Patients will be oxygenated from the time of anesthetic administration until return of 
spontaneous respirations.  Seizure duration will be monitored with two frontal-mastoid EEG 
channels, as well as motor manifestations using the cuff technique.   The cuff technique entails 
the placement of a blood pressure cuff on a limb.  The cuff is then inflated above the systolic blood 
pressure immediately prior to the infusion of succinylcholine.  This maneuver prevents the limb 
from being exposed to the paralytic effects of succinylcholine so that a motor seizure will be 

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observed in that limb, and can be timed.  The succinylcholine will block the expression of a motor 
seizure in the rest of the body, thereby reducing risk of injury to the extremities that can result from 
an unmodified tonic-clonic seizure.  Using conservative criteria (≥20 seconds), generalized 
seizures of adequate duration will be elicited at each treatment. 
MST/ECT
MST will be performed under general anesthesia (as outlined above) in the NYSPI ECT 
suite using a custom MST device with which the PI has 5 years of experimental experience in a 
similar MST protocol, under an Investigational Device Exemption from FDA.  The ECT suite is 
staffed by personnel trained in the acute care of patients undergoing convulsive therapy, and in 
the prompt recognition and treatment of potential post-ictal complications. The ECT suite is fully 
equipped to manage potential medical emergencies.  This emergency equipment includes oxygen 
supply, IV line supplies, emergency medications, and a crash cart.
During MT determination and MST, patients and experimenters will wear earplugs to 
protect inner and middle ear structures from the potential acoustic trauma of the magnetic coil 
stimulation artifact and thus prevent the risk of transient auditory threshold shifts.  
On the first and last session, seizure threshold (ST) will be determined by the ascending 
method of limits procedure. Threshold determination entails the repeated application of 
increasingly powerful stimuli until a seizure is obtained.  At least 20 seconds will be allowed 
between successive stimuli, as is standard practice with ECT, to monitor for delayed onset 
seizures.  For those patients assigned to MST, subsequent treatments will be given at maximal 
stimulator output or up to 6x ST as is standard in unilateral ECT treatments. For those patients 
assigned to ECT, right unilateral ECT will be administered at 6xST using an ultrabrief stimulus 
(0.25-0.3 ms).  Our work has shown that this form of ECT provides the best cognitive profile 
without sacrificing efficacy.  
Treatment will be administered three times per week. There will be no maximum number of 
sessions; the number of treatments will be based on the treating physician’s clinical assessment. 
It is expected that most patients will receive treatment for two to six weeks (six to 18 sessions).
If MST fails to induce a seizure:  To date, we have been successful in inducing seizures in 
all humans and animals that have undergone the procedure. Therefore, we do not expect it to be 
a common occurrence for MST not to induce a seizure.  However, if a patient fails to have a 
seizure during any MST session the patient will be offered to repeat the treatment with different 
frequency and amplitude settings or will be dropped from the randomized portion of the study and 
offered routine clinical care.  Ultimately, the decision as to what is the best next treatment is a 
clinical one to be made by the patient in consultation with the treatment team.  
Electroencephalography
Quantitative, Regional Brain Electrical Activity (qEEG) will involve recording multi-lead 
topographical EEG during eyes closed and eyes open conditions.  EEG will be conducted at 
pretreatment and during the first week post-treatment.  In addition, multi-lead EEG will be 

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conducted during the convulsive treatment course at the second and penultimate treatments.  
These acute studies involve EEG measurement for a 10 minute period prior to treatment, 
throughout the treatment period, and for 10 minutes in the immediate postictal period.  EEG 
electrodes will be slotted (or made from plastic) to reduce electrode heating. 
Neuropsychological Testing and Audiometry
The neuropsychological testing was modeled after that used in our IRB protocols 5097, 
4371, 4087, and 3482 to enable comparisons across studies.  A technician masked to the 
treatment condition will administer neuropsychological tests at various time-points to assess the 
acute, short-term, and long-term memory effects of the treatments (see Table 1).  A short version 
of the battery will be administered before and after each treatment session, while a longer version 
will be administered at baseline, within 72 hrs post-Phase 1, and 2-month and 6-month follow ups. 
This battery was designed to be brief to enhance completion rates, and to quantifiably sample a 
sufficient range of functions to have clinical relevance and scientific value. The short- and long-
term batteries were designed to sample those aspects of cognition (a) most vulnerable to ECT 
(e.g., retrograde and anterograde amnesia), and (b) most reliant on prefrontal lobe function (e.g., 
executive function tasks) which is the target site of MST stimulation. Psychomotor tasks are 
included as controls. The battery includes measures to contrast actual performance with the 
patient’s subjective experience. At baseline, after the sixth treatment, and after the final treatment, 
patients will undergo pure tone audiometry testing for safety screening. If a change in auditory 
threshold is discovered, the treating physician will inform the patient and discuss whether or not to 
continue with treatment. Furthermore, if a change is discovered, the patient’s hearing will be 
tested again periodically until either it returns baseline or the clinician determines that the change 
is permanent.  
Clinical Ratings 
Ratings will be conducted at baseline, twice a week during acute course of MST/ECT 
treatments, within 7 days after the last MST/ECT session, and at 2 and 6 month follow up. For 
remitters, ratings will continue bimonthly for two months, then monthly during Phase 2 through the 
6-month "follow-up". The primary clinical outcome measure is the HRSD24 since this is the 
primary outcome measure in the ECT literature. The Inventory of Depressive Symptomatology – 
Clinician-Rated (IDS-C30) will serve as a secondary outcome measure. Other clinical ratings will 
include the IDS-self report (IDS-SR30), the Clinical Global Impression - Improvement (CGI-I), the 
Global Assessment of Functioning (GAF), and the Medical Outcomes Study Short-Form Health 
Survey. The IDS-C30 and the IDS-SR30 provide objective and subjective ratings of antidepressant 
response using comparable items. The Columbia University ECT Side Effects Scale will be 
administered after every treatment. This scale was sensitive in detecting differences between 
MST and ECT in acute somatic side effects.  Subjective memory complaints will be assessed with 
the Squire Memory Complaint Questionnaire and the Cognitive Failures Questionnaire. The 
YMRS will be utilized to screen for treatment emergent hypomania or mania, which can be 
observed with ECT, but which has not been reported with MST.

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Consistent with the standard of practice in ECT, there is no predetermined minimum or 
maximum number of treatments. Treatments will be continued until maximal improvement is 
achieved. During initial taper and washout, patients who test 6 or higher on a weekly CGI-I will be 
dropped from the study and referred for clinical treatment. If significant clinical improvement is not 
achieved by the 8th session (>25% drop in HRSD24), treatment will be stopped.  Otherwise, 
treatment will be continued until there has been a plateau (defined as drop in HRSD24 of equal or 
less than 3 points as measured on week-to-week basis on non-treatment days, i.e. Tuesdays and 
Thursdays). Should we have a lesser improvement than indicated by this week to week 
benchmark, provoked by an unusual and/or unanticipated stressful event, then we may appeal to 
IRB for exemption of the 3- point drop rule. In addition, If the patient receives 15 treatments, the 
Director of the ECT Service will review the case with the clinical staff and document the clinical 
decision about continuing treatment. If more than 25 treatments need to be given, the Clinical 
Director is consulted and consent will be re-obtained. 
Clinical response is defined as ≥50% drop in HRSD24. Remission is defined as ≥60% drop 
or HRSD24 ≤10. The HRSD remission number is informed by our experience with the elderly 
population receiving convulsive therapy and is consistent with other comparable protocols 
previously approved by NYSPI (as in PRIDE study).  
Treatment options following acute study treatment
For the responders to Phase-1 study treatment, the acute phase treatments will be 
terminated upon achieving maximum therapeutic benefit as previously described. These patients 
will be then started on maintenance medication prior to discharge, in coordination with their 
existing outpatient provider. Upon discharge, treatment will be transferred back to the 
existing primary care doctor or psychiatrist. Should patients wish to transfer their care to a 
different primary provider, appropriate referral will be made with an appointment scheduled 
typically within one week from the day of discharge. Maintenance medications will be provided to 
patients at no cost to last until their first appointment with their primary provider. There will be no 
other outpatient treatment offered following discharge from this study.
Patients, who fail to improve as part of study treatment, will be offered standard-of-care 
inpatient clinical treatment at no cost to the patient, which may include medications or open ECT, 
to be determined by the clinicians responsible for patients’ care in consultation with the ECT MD 
and PI of the study. To protect blinding of the study, previous ECT/MST treatment will be 
discussed only with the inpatient clinician-attending prior to determining the best post-study 
treatment option, on the condition that this attending not reveal the randomization to the patient or 
other personnel.    
Patients, who were receiving study treatment as outpatients and failed to respond, will be 
given a choice of returning to their physician for ongoing treatment or being re-admitted for 
inpatient ECT, following discussion of the study treatment with their provider in the same manner 
as described above for inpatient non-responders. ECT as a clinical inpatient is available at no cost 
to the patient. 

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TMS motor cortex excitability studies
A battery of TMS motor cortex excitability studies will be performed in the week prior to and 
the week following the course of MST, to explore the neurophysiological responses to the 
treatment.  This is the same battery as used in protocols # 5097, 3482 and 4371, and consists of 
motor threshold, central motor conduction time, paired pulse curve, and input/output curve.  All of 
these assays are performed with single pulse magnetic stimulators (low frequency).
Biochemical Studies
At the second, sixth, and penultimate treatments, blood will be drawn immediately before 
and at 3 time-points following the seizure (5, 15, and 30 minutes).  This blood will be assayed for 
prolactin, and cortisol levels to explore the neuroendocrine response to the treatment. If a viable 
venous draw is unsuccessful, an attempt to draw blood will be made on the subsequent 
treatment/s. 
Naturalistic Follow-Up (Phase 2).
Patients will be followed for 6 months to monitor persistence of clinical benefit and of side 
effects. To be classified as a relapse during the follow-up phase, patients must have a 
HRSD24≥20 and a ≥10 point increase in HRSD24 maintained across 2 visits at least a week apart, 
or experience emergence of psychosis or suicidal ideation, or require hospitalization. This 
definition should capture sufficient worsening that would necessitate a change in clinical 
management. To characterize the nature of the naturalistic treatment received during Phase 2, 
information on treatment type, dosage, and duration of exposure will be collected at each 
assessment. We will follow nonremitters who subsequently receive ECT with pre and post 
HRSD24 scores to determine whether ECT following MST results in a significant rate of response.
You can upload charts or diagrams if any
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
Failing to respond to treatment is defined as not having achieved a ≥ 25% drop in HRSD after 
completing treatment #8. In such case, the treatment team will be free to recommend whatever 
treatment is judged best for the patient, based upon his/her clinical status and medication history. 
Treatment as a clinical inpatient at NYSPI will be provided at no cost.  
  

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Blood and other Biological Samples
Please create or insert a table describing the proposed collection of blood or other biological specimens
Baseline lab work:  approximately 25 ml of blood, which include routine preECT labs (blood and 
urine) workup to screen for medical conditions that may affect the ECT course and a toxicology 
screen for substance use. 
Biochemical studies:  approximately 25 ml at each of 3 assessments during the second, sixth, and 
penultimate treatments, analyzed for serum Prolactin and Cortisol.
 
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
 
 
Table 1. Schedule of Research Procedures
Assessments*
Baseline
Treatment 
#1
Every 
Tx
Post Tx 
#6
Last 
Tx
Post 
Phase 1
2-
Month
6-
Month
Clinical Ratings
 
 
 
 
 
 
 
 
Structured Clinical Interview for Diagnosis (SCID) – 1 hr
x
 
 
 
 
 
 
 
Transcranial magnetic stimulation Adult Safety Screen (TASS) – 
5 min
x
 
 
 
 
 
 
 
Antidepressant Treatment History Form (ATHF) – 30 min
x
 
 
 
 
 
 
 
Hamilton Rating Scale for Depression (HRSD24) – 30 min
x
x
x*
x
x
x
x
x
Inventory of Depressive Symptomatology (-SR30, -C30) – 10 min
x
 
 
x
 
x
x
x
Medical Outcomes Study Health Survey (SF-36) - 15 min
x
 
 
 
 
x
x
x
Clinical Global Improvement (CGI) – 5 min
x
 
 
 
 
x
x
x
Global Assessment of Functioning (GAF) – 5 min
x
 
 
 
 
x
x
x
Young Mania Rating Scale (YMRS) – 10 min
x
 
 
 
 
x
x
x
Columbia ECT Subjective Side Effects Scale  - 5 min
x
x
x
x
x
x
 
 
Neuropsychological Battery - Acute Effects
 
 
 
 
 
 
 
 
Treatment Effects Battery – 45 min
x
x
x
x
x
 
 
 
 
 
 
 
 
 

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 * HRSD24 testing will be performed twice weekly, on non-treatment days.
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
Neuropsychological Battery - Short and Long-Term Effects 
1 ½ days
 
 
 
 
 
 
 
 
Global Cognitive Function 
 
 
 
 
 
 
 
 
Modified Mini Mental Status Exam (mMMS) and Wide Range 
Achievement Test
x
 
 
 
x
 
x
Anterograde Learning and Memory 
 
 
 
 
 
 
 
 
Buschke Selective Reminding Test, WRAT3
x
 
 
 
x
 
x
Complex Figure Copying (with 20 min delay) 
x
 
 
 
 
x
 
x
Retrograde Memory
 
 
 
 
 
 
 
 
Autobiographical Memory Interview - Short Form 
x
 
 
 
x
 
x
Goldberg Remote Memory Questionnaire 
x
 
 
 
 
x
 
x
Psychomotor 
 
 
 
 
 
 
 
 
Simple Reaction Time 
x
 
 
 
 
x
 
x
Choice Reaction Task, Grooved Pegboard, Trail Making A 
x
 
 
 
 
x
 
x
Executive Function
 
 
 
 
 
 
 
 
N-Back Working Memory, Trail Making B, Sorting, Stroop 
x
 
 
 
x
 
x
Digit Span, Controlled Oral Word Assoc, Fluency, Go-No Go 
x
 
 
 
x
 
x
Subjective Cognitive Evaluation
 
 
 
 
 
 
 
 
Cognitive Failures Questionnaire 
x
 
 
 
 
x
 
x
 
 
 
 
 
 
 
 
 
Neurophysiological Studies
 
 
 
 
 
 
 
 
MST Seizure Threshold Titration 
 
x
 
 
x
 
 
 
TMS Motor Threshold Studies
x
 
 
 
 
x
 
 

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MagVenture MagPro MST Device
Manufacturer and other information
MagVenture, Inc.
 
Approval Status
IDE is approved
IDE#
G090145-R002
Who holds the IDE/IDE sponsor?
IDE is held by PI/CU Investigator
Rowny, Stefan, MD
Device #2
Name of the device
Magstim MST Device 
Manufacturer and other information
Magstim Company Limited
Approval Status
IDE application is pending
Who holds the IDE/IDE sponsor?
IDE is held by PI/CU Investigator
Rowny, Stefan, MD
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
Yes
Maximum duration of delay to any treatment 
Patients will undergo a taper followed by a 5-day psychotropic medication washout prior to the 
start of MST. The duration of the taper depends upon the particular medications the patient is 
taking. Some of these medications would need to be tapered and washed out or reduced for 
clinical reasons prior to receiving convulsive therapy (e.g., lithium, benzodiazepines) and are not 
strictly related to research procedures. Although this taper varies in each individual, in most cases 
it can be accomplished in 3 to 5 days and is also required in approved convulsive treatment 
(ECT). Therefore, the maximum expected delay to treatment is 8 to 10 days and in cases of no 
medication washout the maximum delay to treatment is usually no more 3 days, considering that 
treatments are offered 3 times a week and allowing for the first day to be dedicated to inpatient 
intake procedures. 
  

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Maximum duration of delay to standard care or treatment of known efficacy
There is no sham or placebo in this study, but MST is experimental and therefore does not have 
known efficacy. For those patients randomized to MST, the delay to receiving a known active 
treatment is the duration of Phase 1 plus the washout period. The duration of Phase 1 depends 
upon clinical response (see above), but patients will be withdrawn from the study and given 
routine clinical care with a treatment of known efficacy if they do not achieve improvement by the 
8th treatment (treatments are given x3/wk, so 8 treatments would take 2 ½ weeks plus medication 
washout period). For those patients randomized to ECT, they will begin receiving a treatment with 
known efficacy immediately after the 5-day washout.
 
Treatment to be provided at the end of the study
Patients who fail to respond to MST or RUL ECT will be offered standard treatment as clinically 
indicated by the inpatient or outpatient treatment team, which may include another form of ECT 
(e.g. bilateral) if clinically appropriate or antidepressant medication. The treatment team will be 
free to recommend whatever treatment is judged best for the patient, based upon his/her clinical 
status and medication history. For patients who have responded to MST or ECT, it is 
recommended that they be started on antidepressant medication to maintain that response and 
prevent relapse.
Clinical Treatment Alternatives
Clinical treatment alternatives
Depending on severity of depression and adequacy of previous treatment trials, a different class 
of medication or therapy may be suggested prior to acceptance of a patient to a study.  
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
 We expect that the side effects of MST should be equal to or less than the side effects of 
ECT (discussed in detail below). Both treatments entail the induction of electricity in the brain and 
the initiation of a seizure. Magnetic fields do not penetrate as deeply as electric fields, suggesting 
that the cognitive side effects resulting from the stimulation of deeper brain structures should be 
less with MST than ECT. In the first case in which MST was conducted in humans, the only 
reported side effect was headache. In the first trial of 10 patients conducted at NYSPI, we found 
that MST had fewer acute cognitive side effects than ECT. In our second trial of MST (10 at 

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NYSPI and 10 at UTSW), we found MST was well tolerated with substantially fewer cognitive side 
effects than patients receiving ECT in other studies simultaneously conducted. Now a series of 10 
patients have been treated with MST in Bern, Switzerland, with comparable results and 20 more in 
Germany also with the same results. In none of these cases has there been a significant or 
unexpected adverse event. There has been one mention in the literature of dental pain that may 
persist after the MST treatment course has ended. The cases of inadvertent seizure induction with 
rTMS in unanesthetized subjects have indicated no evidence of any long-term adverse medical or 
neurological consequences of rTMS-elicited seizures. Since MST is investigational, MST may not 
be effective, thus receiving MST may delay effective treatment. Delay in treatment of depression 
may result in worsening of the clinical condition (e.g., intensified symptoms, suicidal ideation). As 
with all antidepressant treatments, including ECT, there is a theoretical risk of inducing mania. 
Patients participating as outpatients also have risk of falling, risk of noncompliance with treatment 
instructions, and risk of danger from operating dangerous machinery, such as driving or using the 
stove.
ECT:   
Immediately following ECT, patients are typically disoriented or confused. Following ECT 
sessions, some patients report headache, muscle soreness, or nausea. These side effects usually 
respond to simple treatment. Serious medical complications are rare. Dislocations, bone fractures, 
and dental complications have been reported with ECT, but have not been observed at NYSPI for 
the last 25 years. Cardiac complications are more common and constitute the leading cause of 
morbidity and mortality with ECT. The likelihood of these complications is reduced by (1) careful 
medical workup and the use of cardiology consultants in patients with significant preexisting 
cardiac disease; (2) careful monitoring of cardiac status during ECT; (3) modification of anesthetic 
procedures for prophylactic purposes (e.g., use of pharmacological agents to block hemodynamic 
changes). The availability of senior neuroanesthesiologists, who average several years of 
experience in conducting anesthesia for ECT, limits the development or sequelae of cardiac 
complications. Fatality associated with ECT is estimated to occur in 1/10,000 patients, and to our 
knowledge has never occurred at NYSPI.
ECT commonly results in memory deficits. These memory deficits are of two types: 
anterograde and retrograde amnesia. The anterograde amnesia involves a deficit in the capacity 
to retain newly formed information over delays (i.e. rapid forgetting). It is most intense immediately 
following a treatment, and displays rapid recovery. There is little objective evidence that 
anterograde amnestic deficits persist more than two weeks following an ECT course. In group 
data, studies at NYSPI have failed to observe persistent anterograde deficits. Retrograde amnesia 
pertains to a retrieval (and in some cases recognition) deficit for memory of events that occurred 
before and during the ECT course. This deficit also appears to be most marked immediately 
following a treatment and is less likely to occur, with respect to memory events temporally further 
away from the treatment. Thus the descriptor ‘grade’ in the name. In an overwhelming majority of 
cases the deficit pertains to recent memories, for example those during the patient’s 
hospitalization, with more remote memories spared. While subject to rapid recovery, this deficit 
may never totally recede. Objective testing and subjective patient reports suggest that some 

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patients will have permanent spottiness in memory for events that occurred close in time to the 
ECT course.
The magnitude of both memory deficits is sensitive to the parameters used in the conduct 
of ECT. In general, these deficits are more severe with bilateral versus right unilateral electrode 
placement, sine wave versus brief pulse stimulation, higher versus lower electrical intensity, closer 
spacing of the treatments, and larger number of treatments. Precautions that are taken in this 
protocol include the use of brief pulse, constant current stimulation and the titration of electrical 
dosage relative to seizure threshold. Further, the number of treatments is limited to that necessary 
to achieve clinical response or to ensure an adequate ECT trial. During the treatment course, 
there is careful monitoring of acute (post-ictal) and short-term (inter-ictal) cognitive side 
effects. Spacing of treatments may be increased or the treatment course terminated in the context 
of unacceptable side effects. Patients participating as outpatients also have risk of falling, risk of 
noncompliance with treatment instructions, and risk of danger from operating dangerous 
machinery, such as driving or using the stove.  
Evaluation Procedures: 
The medical evaluations present no risks beyond what is expected for routine clinical care 
of a patient undergoing a course of ECT. The procedures involve collection of blood through 
venipuncture for the initial screening blood work-up (25 ml).  
Neuropsychological Testing: 
            There may be a risk of fatigue from participation in the neuropsychological testing, but 
there are no other known risks from these procedures.
Medication Washout: 
Withdrawing antidepressant medication carries a risk of worsening the underlying 
depression. However, our ECT protocols require 5 days. Washout also carries a risk of withdrawal 
side effects, depending upon the specific medications.  
Motor Cortex Excitability Studies: 
The methods used to evaluate motor threshold and other measures of motor cortex excitability 
involve the administration of single or paired pulse TMS given at long inter-pulse intervals. The 
most serious known risk of low frequency TMS is seizure. Low-frequency TMS has not been 
associated with seizure in appropriately screened individuals. If a patient has a seizure, he/she 
may require admission to a medical service and follow-up neurological evaluation. Having had a 
seizure may adversely affect medical insurability, future employment, and ability to drive. It is not 
known whether having had one seizure will make a person more prone to have future seizures. If 
a seizure occurs, the patient will be given a letter documenting that it was experimentally 
induced. The most commonly reported side effect of low frequency TMS is a “muscle-tension” 
type headache. About 17 out of every 100 people will experience a mild headache with this type of 
TMS. If a headache occurs, it usually starts during or immediately after the TMS and lasts from 

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minutes to hours later. The headache usually goes away with standard, non-narcotic, pain 
medications (aspirin, acetaminophen or Ketorolac). Neck pain may also occur, and it is also 
usually managed easily with standard over the counter painkillers. There may also be scalp 
discomfort due to contraction of scalp muscles. The clicking noise produced during the stimulation 
may temporarily affect hearing. The earplugs will reduce this risk. Patients participating as 
outpatients also have risk of falling, risk of noncompliance with treatment instructions, and risk of 
danger from operating dangerous machinery, such as driving or using the stove.
Describe procedures for minimizing risks
Procedures for Minimizing Risks:
The safety measures recommended by the manufacturer regarding not operating the 
magnetic stimulation device in the context of cardiac pacemakers, metallic implants, and loose 
paramagnetic objects will be followed. These exclusions prevent the risk of pacemaker 
malfunction and the torque that may be exerted on metallic implants by the magnetic field. Metallic 
objects are removed from the vicinity of the device (≤ 10 cm). This includes removing jewelry, 
scissors, needles, and other paramagnetic objects. Magnetic sensitive materials (e.g., watches, 
credit cards, computer disks) are also removed to avoid the possibility of damage. When not in 
use, the Magnetic Stimulator is disabled and the cart housing it is locked.  
Screening of Subjects Prior to Stimulation:
As described above, the screening assessment of potential subjects will identify and 
exclude from participation individuals with current or past medical conditions that may place them 
at increased risk for adverse effects from magnetic stimulation. Screening will include 
administration of the Transcranial magnetic stimulation Adult Safety Screen (TASS), which 
assesses medical history, neurological history (seizure, stroke, and brain lesion), head trauma, 
metallic implants, and implanted devices. Screening will be performed by physician evaluation, 
physical examination, and blood/urine analysis.
 Screening to allow outpatient participation after initial 3 inpatient treatments will also 
include an evaluation of a responsible adult, who will assist the patient during the time of the acute 
treatments. The function of the “Responsible Adult” is to provide direct support to the research 
participant receiving convulsive treatment on the outpatient basis, and to facilitate safety by 
enhancing communication between the treating team and the patient. The responsible adult does 
not need to be domiciled together with the participant, but needs to be with the patient for 24 
hours after each treatment, as per NYSPI policy. The responsible adult will be given a checklist to 
use in discharging his/her responsibilities. 
Protection From Excessive Noise:
Earplugs will be worn by staff and patients prior to any magnetic stimulation to prevent 
exposure to excessive noise.  

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Protection From Excessive Temperatures:
The stimulation coil is insulated to retard heating. The coils contain temperature sensors, 
providing continuous readouts. The controller software disables the device if coil temperature 
exceeds safe levels. Plastic or slotted EEG electrodes that have been shown on testing to avoid 
electrode heating with MST will be used in this study.  
Supervision of Subjects During Stimulation Sessions:
Stimulation sessions will be conducted by a physician team (psychiatrist and 
anesthesiologist) with the participation of other trained personnel, including a licensed RN. These 
personnel will be in visual and auditory contact with the patients at all times. Health status will be 
monitored continuously as described above. 
Emergency Power Interruption:
In the event of an emergency, stimulation will be discontinued immediately by removing the 
coil from the head and then disabling the device. 
Controller Unit Safety Features:
The dedicated computer controller software for the Magnetic Stimulator has internal limits 
on stimulation parameters. These limits prevent the device from being programmed to deliver 
pulses that exceed predetermined limits. The software logs all pulses administered, as well as 
parameter values.
Emergency Medical Procedures:
If at any moment during the stimulation session, there is a clinical suspicion of a possible 
serious adverse health effect, the coil will be immediately removed from the patient’s head and the 
stimulator will be disabled. The ECT suite is staffed by medical personnel with extensive 
experience in ECT and has access to emergency equipment (oxygen, IV medications, crash cart) 
to handle potential adverse events.
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 

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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.
       
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects  
Direct Benefits to Subjects
Patients with major depression will receive a course of convulsive therapy. ECT is an approved 
and effective treatment for major depression, but the therapeutic effects of MST are not yet 
known.
 
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
No
References
References
Rowny, S., and Lisanby, S.H.: Brain Stimulation. Chapter 109 in Tasman, A., Kay, J., Lieberman, 
J., First, M.B., and Maj M. (Eds) Psychiatry Third Edition. John Wiley & Sons, Ltd. 2008. 
Pp. 2354-2371.
Rowny, S., and Lisanby, S.H.: Other Brain Stimulation Methods.  Chapter 31.34b in Sadock, B.J, 
Sadock, V.A., Ruiz, P. (eds).  Kaplan & Sadock’s Comprehensive Textbook of Psychiatry. 
 Wolters Kluwer / Lippincott Williams & Wilkins.  New York.  2009. Pp. 3301-3314. 

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Rowny, S, Benzl K, Lisanby SH. Translational development strategy for magnetic seizure therapy. 
Exp Neurol. Sep 2009;219(1):27-35. PMID: 19348798. PMCID: PMC2997268
Rowny, S., Cycowicz, Y., McClintock, S., Truesdale, M., Luber, B., Lisanby, SH. Differential heart 
rate response to magnetic seizure therapy (MST) relative to electroconvulsive therapy: a 
nonhuman primate model. Neuroimage. Sep 2009;47(3):1086-1091. PMID: 19497373
Uploads
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#6427_CF_Unbolded.pdf
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Upload evidence of FDA IDE approval(s)
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#6427_HIPAA_Unbolded.pdf
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New York State Psychiatric Institute - Columbia University Department of Psychiatry 
INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
RESEARCH SUMMARY COVER SHEET 
•
The goal of this research is to assess safety and efficacy of magnetic seizure therapy
(MST) in the treatment of depression in the elderly.
•
MST will be compared to a well known, standard of care treatment, called
electroconvulsive therapy (ECT).
•
Participants will be assigned randomly (like flipping a coin), to either MST or ECT
treatment arms.
•
Both groups, MST or ECT, will receive convulsive therapy; there is no placebo group.
•
Participants will have intravenous (IV) line placed on the morning of the treatment.
Through this line they will receive two kinds of medications at the beginning of the
treatment. First medication will make them fall asleep (for a brief period of time,
lasting a few minutes); second one will relax their muscles.
•
During the treatment, participants will remain under the care of two doctors. The first
one is an anesthesiologist – a doctor who puts the patient to sleep and monitors
patient’s vital signs and the second one is the treating psychiatrist.
•
Participants will be asked to wear earplugs because of the brief noise generated during
the treatment, while under anesthesia.
•
Treatments are performed 3 times a week: on Monday, Wednesday and Friday
mornings.
•
In order to evaluate study progress, standard tests will be given before, after and in-
between treatments.

Patient Consent Form 
IRB Protocol # 6427 
Version 07/28/16
1
New York State Psychiatric Institute - Columbia University Department of Psychiatry 
INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
The purpose of this Consent Form is to provide you with information you need to 
consider before you decide whether to participate in this research study. 
STUDY TITLE: IMPROVING OUTCOMES IN GERIATRIC DEPRESSION: 
MAGNETIC SEIZURE THERAPY 
PRINCIPAL INVESTIGATOR:  STEFAN ROWNY, M.D. 
AFFILIATION OF PRINCIPAL INVESTIGATOR:    
NEW YORK STATE PSYCHIATRIC INSTITUTE / COLUMBIA UNIVERSITY 
Purpose of Study and Overview 
You are eligible to participate in this study because you have severe depression and it 
has been recommended that you receive treatment for your depression that uses electricity to 
cause a seizure (convulsive therapy). You have been invited to participate in a research study 
using a new type of convulsive therapy, called magnetic seizure therapy (MST), which will be 
compared to an existing standard of care treatment, electroconvulsive therapy (ECT).  Like 
ECT, MST causes a seizure.  Unlike ECT, which uses electricity, MST uses magnetic fields 
that create a small amount of electricity in the brain to trigger the seizure.  MST is 
experimental and is not approved by the Food and Drug Administration (FDA).  MST has only 
been used previously to treat depression in about 150 patients. Two investigational devices are 
available worldwide, with which magnetic seizure therapy treatments have been performed to 
date. At the time of writing this consent form, 57 individuals have received acute series of 
treatments with the device that we use currently. Limited published data exist at this time, but 
early reports suggest promising results in treating depression with fewer side effects from this 
new convulsive treatment. However, because of the small number of published reports and 
limited number of patients who received this treatment under research conditions so far, it is 
not known if MST is effective in treating depression, particularly depression in the elderly. Its 
safety has not been fully evaluated yet. The most commonly reported side effects will be 
discussed elsewhere. In general, those who received MST treatment have a few minutes of 
confusion after treatment, not different from that of general anesthesia. The risk of short-term 
and long-term memory loss, appears to be minimal, temporary and only in the setting of 
receiving the acute treatment.  This study will compare the effects of MST and ECT in the 
elderly. We will also compare the safety of MST with ECT.  This information will teach us 
more about whether MST may someday be a useful alternative to ECT in the treatment of 
depression. The investigators plan to include 30 participants in this research.  This study is 
funded by a grant from the National Institute of Mental Health. 
Voluntary 
Participation in this research study is voluntary. If you decide not to participate, or if 
you later decide to stop participating, you will not lose any of the benefits to which you are 
otherwise entitled. A decision not to participate or withdraw of your participation will not 
affect your current or future treatment at the New York State Psychiatric Institute or Columbia 
University.  

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You will be notified of significant new findings that may relate to your willingness to 
participate.  
Alternatives to Participation 
You do not have to participate in this study to receive treatment for your depression.  The 
alternative to participating in this study would be to receive other treatments for depression like 
ECT, antidepressant medication, and psychotherapy.  These alternative treatments have their own 
benefits and risks.  The question of whether convulsive therapy or an alternative treatment is best 
for you depends on your prior experience with these treatments, your psychiatric and medical 
condition and other considerations that you should discuss with your doctor.  
Procedures 
Clinical and Study Evaluations:  Before starting treatment, you will be asked about 
your past and current physical and mental health.  During the time that you are receiving 
convulsive treatments and during the week after you finish treatment, you will be interviewed 
about changes in your symptoms and side effects. You will be interviewed about your 
depression and side effects two and six months after the last treatment. 
To test the effects of treatment on your thinking and memory, you will receive a set of 
tests before and after each session. This will take about 45 minutes.  In addition, a longer 
session with similar tests will be given within three days before the start of treatment, within 
three days after the last session, and again 6 months after the last treatment. 
Schedule of testing:  This study is performed in a psychiatric hospital.  On the first 
testing day, you will be admitted to the hospital. Even if you are accepted for outpatient 
treatment, you will still need to be admitted to the inpatient unit for the first week of treatment 
and will receive the same study procedures.  You will be interviewed, have a physical exam, 
hearing test, and an interview about your psychiatric condition.  You will also have your blood 
drawn, give a urine sample, and have a chest X-Ray.  If you are taking medications to treat 
your depression, these medications will be gradually stopped.  You will be off of these 
medications for at least five days before you start receiving treatments.  Therefore, your actual 
delay to treatment may be as short as 5 and possibly as long as 7 days or even longer, 
depending on how you tolerate the medication washout and when the actual washout begins. 
Treatments are given only on Mondays, Wednesdays and Fridays. You will be assigned to 
receive either MST (with magnetic coil placed at the surface of your head) or right unilateral 
ECT (a standard method of ECT with two electrodes touching the scalp). If you decide to 
participate in the study, you will have a fifty percent chance (or 1 out of 2) of receiving MST. 
You will then receive your assigned treatment three times a week. Neither you nor the clinician 
who evaluates the level of your depression will know which treatment you are receiving. The 
study assignment is made in advance by a procedure similar to drawing straws.  Treatments 
will continue usually for two to six weeks, depending on your doctor's judgment of how you 
are responding. Your participation in the study will be stopped after eight treatments if your 
depression does not improve by at least 25% as measured by a test we use (Hamilton 
Depression Rating Scale). There is no maximum number of treatments. However, if you need 
more than 25 treatments, a new consent form will need to be signed.  At the first and last 
treatment sessions, you will receive several stimulations until the smallest amount of MST or 
ECT needed to cause a seizure is reached.  At the other sessions, you will be treated at a dosage 

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above that threshold.  Before and after each session, you will complete tests of your memory 
and thinking.  You will also complete a questionnaire about side effects and be asked questions 
about your depression. After your first, sixth, and last session, your hearing will also be tested. 
If the test shows that your hearing has worsened during the study, the doctor will discuss 
treatment options with you and carefully assess whether to continue with treatment. If the 
hearing tests show that you have experienced hearing loss, your hearing will be tested again 
periodically until either it returns to the level where it was before treatment or the doctor 
determines that it will not improve any more. At the end of the treatment course, one of the 
study investigators will provide you with a letter stating that the seizure(s) you experienced 
were produced as part of an experiment. 
Blood tests:  A blood sample will be taken to carry out recommended tests before 
convulsive therapy. Further blood tests will be drawn at your second, sixth, and next to last 
session to look at hormonal effects of the treatment.  The total amount of blood taken for all 
research procedures will be less than one cup.  This is about half the amount of a typical 
donation to a blood bank. 
 Studies of the nervous system function (Neurophysiology):  A set of tests will be done 
to examine the effects of the MST and ECT on brain activity.  These tests include 
electroencephalography (referred to as EEG, or looking at “brain waves”) and tests of your 
brain’s responses to magnetic pulses (referred to as motor cortex excitability studies).  For the 
EEG, your scalp will be cleaned and sensors placed on your head and near your eyes.  The 
sensors are used to measure the brain waves that naturally occur in your brain, while you lie 
quietly.  The EEG will be measured before treatment, during two of the MST/ECT sessions, 
and during the week following the last treatment. 
The test of your brain’s responses to magnetic pulses will be done before your first 
session and in the week following your last session.  During this procedure, small sensors will 
be attached to the skin of your hands and/or legs to measure muscle twitching. A technician 
will hold a magnetic coil over your head or on the back of your neck.  This coil will give a 
number of quick magnetic pulses.  Some of these pulses will cause your fingers or foot to 
twitch.  Earplugs will be worn throughout the testing because the stimulator makes a clicking 
noise. 
MST/ECT: At each treatment, you will be under the care of an anesthesiologist, a 
psychiatrist, and a nurse.  To receive each treatment you will be brought to a special room 
containing all the appropriate equipment that is needed for your treatment.  The treatments are 
given in the morning, before breakfast.  Because the treatments are done under general anesthesia 
(while you are asleep), you will not be allowed to drink or eat for at least eight hours before each 
treatment. During the treatment, medications will be given to you through a thin plastic tube (an 
“IV line” or catheter) placed in your arm.  You will be given medicine that will quickly put you to 
sleep.  You will be given a second drug that will relax your muscles.  Because you will be asleep, 
you will not feel pain or discomfort during the procedure. 
To prepare for the treatments, monitoring sensors will be put on your head and other 
parts of your body. This is done to monitor your brain, your heart, and your blood pressure.  
These recordings involve no pain or discomfort. A blood pressure cuff will be put on one of 
your legs.  Before starting the MST/ECT procedure, you will be asked to remove any metal or 

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magnetized objects (such as keys, jewelry, hair pins, and credit cards).  MST makes a loud 
clicking sound, so you will be given earplugs for your comfort and safety.  
If you are assigned to MST, after you are asleep the MST coil will be placed on your 
head.  MST is given using a magnetic stimulator.  A magnetic stimulator is a device that makes 
a magnetic field.  The magnetic field is made by passing current through a coil of wire.  The 
magnetic field passes through the skull to the brain. The magnetic field creates a small amount 
of electricity in the brain.  That electricity triggers a seizure (convulsion). 
If you are assigned to ECT, after you are asleep, electrodes used to stimulate the brain 
will be placed on your head.  ECT is given using an electrical stimulator, which is a device that 
can pass an electrical current between two stimulating electrodes.  When the current is passed, a 
seizure is produced in the brain. 
Because you will have received a medication to relax your muscles, body movements 
that would ordinarily happen during a seizure will be much weaker.  The seizure will last for 
about one minute.  Within a few minutes, the medicine that put you to sleep will wear off and 
you will wake up.  You will be given oxygen to help you breathe.  After waking up, you will be 
taken to a recovery room, where you will be watched for about 45 minutes (the time varies for 
different people) until you are ready to leave the recovery area. 
You will be monitored very closely while the seizure is going on.  There will be sensors 
on your forehead that will allow the psychiatrist to track the progress of the seizure in your 
brain. The psychiatrist and nurse will also monitor your seizure by inflating a blood pressure 
cuff around one of your ankles.  This cuff decreases the amount of muscle relaxant that can 
reach your foot, so that the psychiatrist and nurse will be able to see your foot moving even 
though the rest of your body is relaxed. Your motor seizure (seizure visible in your foot) will 
also be timed. 
If MST fails to cause a seizure, you will be allowed to wake up and your treatment 
options will be discussed with you.  At any point in the study, you are free to switch to ECT if 
MST fails to cause a seizure or to improve your depression.  If you do not respond to treatment, 
you will be provided other treatment options that are best for you. As a clinical inpatient at 
NYSPI other psychiatric treatment options would be provided at no cost. 
Risks and Inconveniences 
Experimental Nature of the Treatment:  MST is experimental and it may have 
unknown side effects. MST may not help your depression get better and it is possible that your 
depression will get worse; receiving MST may delay your ability to receive effective treatment.  
Delay in treatment of depression may also result in making your symptoms worse.  
Medication Withdrawal:  Stopping your medications that you are taking to treat your 
depression, if any, may cause your depression to get worse.  There may also be side effects 
from stopping some medications. Your medications will be stopped on a schedule that is best 
for you so that these effects can be minimized.  The length of time of your withdrawal from 
medication will depend on the type of medication you are currently taking. 
Risk due to general anesthesia: Both MST and ECT require general anesthesia. As 

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with any procedure where you are put to sleep (general anesthesia), there is a remote risk of 
death.  The risk of death attributable to the management of general anesthesia with convulsive 
treatment is estimated to be one out of 10,000 patients treated. 
Risks common to outpatient Treatment for both MST and ECT:  If you participate as 
an outpatient, there is an increased risk of falling and thus injuring yourself after each 
treatment, risk of injury from operating dangerous machinery (such as driving or using the 
stove). If you eat or drink after midnight, serious risk of aspirating the content of your stomach 
exists during anesthesia. This can lead to pneumonia and other serious medical complications, 
including in rare cases, death. To reduce these risks, we require that in order to participate as 
an outpatient, you remain under the supervision of another responsible adult who will oversee 
the treatment regimen. We also require that a minimum of 3 treatments be administered on the 
inpatient unit. 
MST: Although it is expected that the side effects of MST will be similar or less 
intense than the side effects of electroconvulsive therapy (ECT), the risks and benefits are not 
known.  The risks may include memory loss, confusion, headache, muscle soreness, nausea, 
and dental pain. It is possible that, if you experience dental pain, it could last beyond when 
your MST treatment ends.  Both ECT and MST put electricity into the brain and cause a 
seizure.  Magnetic fields do not enter into the brain as deeply as the electric fields used in ECT.  
This might mean that the memory side effects from the stimulation of deeper parts of the brain 
may be less with MST than ECT, but this is not known.  In the cases of healthy volunteers who 
had accidental seizures with magnetic stimulation, there have been no signs of any long-term 
side effects. 
The clicking noise made by the stimulator may affect hearing for a short time.  
Earplugs reduce this risk, so you will be asked to wear earplugs during MST.  As with all 
antidepressant treatments, including ECT, there is a possible risk of inducing mania. 
ECT: Like other medical procedures, ECT involves some risks. Serious medical 
complications with ECT are rare.  With introduction of modern anesthesia, bone fractures and 
dislocations are exceedingly rare and none such occurred in the last 25 years of our experience 
with treatments in this institution. Each patient receives a dental exam by the anesthesiologist 
prior to treatment to address any potential problems and to reduce the risk of dental 
complications like teeth or caps cracking.  While also rare, the most common medical 
complications with ECT are changes in heart rate and rhythm, which can be effectively treated 
in most cases.  To reduce the risk of medical complications, you will receive a careful medical 
evaluation before starting ECT.  But, even with precautions there is a small chance that you 
may have a medical complication.  If this happens, medical care and treatment will be started 
immediately.  Facilities to handle emergencies are available. 
A common side effect of ECT is memory loss.  How much memory is lost is likely to 
be related to the number and type of treatments given.  A smaller number of treatments is 
likely to cause less memory loss than a larger number of treatments.  The memory problems 
with ECT follow a certain pattern.  Shortly after a treatment, the problems with memory are 
most noticeable.  As more time goes by, memory improves.  Shortly after the last ECT 
treatment, you may have trouble remembering things that happened before and while you 
received ECT.  Problems with memories for the past may go back to several months before you 

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had ECT, and rarely, to one, two, or more years.  Many of these memories will return during 
the first few months after ECT.  However, you may be left with permanent gaps in memory, 
especially for things that happened around the time of the ECT treatments.  In addition, for a 
short period following ECT, you may have trouble learning and remembering new events.  
This difficulty in making new memories should be short and will most likely go away within 
several weeks after the last ECT treatment. 
The amount of confusion and memory problems during and shortly following ECT 
varies among people.  However, depression itself worsens learning and memory.  A small 
percentage of patients report severe problems in memory that last for months or even years.  
The reasons for these reports of long-lasting memory problems are not fully understood.  
However, as with any medical treatment, people who receive ECT differ in the way they 
experience side effects.  Rarely, ECT may cause permanent and large gaps in memory. 
When you wake up after each treatment, you may feel confused.  The confusion usually 
goes away within an hour.  Shortly after the treatment, you may have a headache, muscle 
soreness, or feel sick to your stomach.  These side effects usually respond to simple treatment. 
Because of the possible problems with confusion and memory in both ECT and MST, it 
is important that you not make important personal or business decisions during treatment or 
immediately following treatment.  This may mean postponing decisions about financial or family 
matters.  After the treatment, you will begin a “convalescence (recovery) period.” This usually 
lasts one to three weeks, but this varies from patient to patient.  During this period you should 
not drive, do business, or other activities for which poor concentration or memory may be a 
problem, until your doctor tells you to do so. 
Neurophysiological Studies involving EEG: There are no anticipated risks of the EEG 
procedure.  EEG electrodes will be slotted or made from plastic to reduce electrode heating, as 
recommended by the literature. 
Neurophysiological Studies to determine Motor Threshold: 
The tests of muscle twitching use magnetic pulses given at low frequency (less than one 
per second).  Low frequency magnetic pulses pose no significant health risk.  Electrical current 
is produced in the brain from magnetic pulses.  This current is well below harmful levels.  The 
most serious known risk of low frequency magnetic stimulation is seizure, although low 
frequency magnetic stimulation has not been known to cause seizure in properly selected 
individuals.  In spite of these precautions, there is a chance that you will experience a seizure 
or other medical complication from low frequency magnetic stimulation during this test. If you 
have a seizure, you may have to be admitted to the hospital and follow-up neurological 
evaluation.  Having had a seizure may adversely affect your medical insurance, your future 
employment, and your ability to drive.  It is not known whether having had one seizure will 
make a person more likely to have future seizures. 
The most commonly reported side effect of low frequency magnetic stimulation is a 
“muscle-tension” type headache.  About 17 out of every 100 people will experience a mild 
headache with this type of magnetic stimulation.  If a headache occurs, it usually starts during 
or immediately after the low frequency magnetic stimulation and lasts from minutes to hours 
later.  The headache usually goes away with standard over the counter pain medications 

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(acetaminophen, ibuprofen, Toradol (ketorolac tromethamine)).  Neck pain may also occur, 
and it is also usually managed easily with the same standard over the counter painkillers.  You 
may also experience some discomfort on your head where the coil is held.  This is due to 
contraction of scalp muscles.  The clicking noise produced during the stimulation may 
temporarily affect hearing.  The earplugs will reduce this risk. 
Blood tests:  A blood sample will be taken to carry out typically recommended studies 
before convulsive therapy. For most people, drawing blood does not cause any serious 
problems. However, there is a risk of bleeding, bruising, discomfort, dizziness, infections and 
pain at the needle site.  These side effects usually go away in a few days. 
Clinical Evaluation, Neuropsychological Procedures and Physical Examination:  
There are no known or expected risks to you from the interview about your history.  There are 
no known risks of the physical and neurological examination.  The interviews are time 
consuming and they are about personal matters. It is possible that you will feel upset, tired or 
anxious. If this happens, you can choose not to answer specific questions or ask to have the 
interview stopped at any time. 
Unforeseen risks: A previously unknown problem could result from your participation 
in this research. There could be an interaction between MST/ECT/anesthesia medication, and 
other medications you take (prescribed or over the counter). It is not possible to estimate the 
chances of such problems or how serious the problems could be. 
Benefits 
You may or may not benefit from this study. Whether you are assigned to receive ECT 
or MST, your depression may improve, although there is no guarantee that this will happen. 
Information obtained from this study may add to knowledge about safer treatments for severe 
depression. 
Confidentiality 
Your right to privacy and the confidentiality of your participation in this project, should 
you choose to participate, will be safeguarded and, if research papers are written, you will not be 
mentioned by name. Research records, like other medical and clinical records, will be kept 
confidential to the extent permitted by law. Any information obtained during this study and 
identified with you will remain confidential. Records will be available to the research staff, and 
Federal, State and Institutional regulatory personnel, who may review records as part of the 
routine audits. There are legal advocacy organizations that have the authority under state law to 
access otherwise confidential research records, though they cannot re-disclose this information 
without your consent. All information will be stored in locked files and will not have your name 
or any other identifying information associated with it. 
All data (written and electronic) will be coded. A master list matching the subject 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 your name to code 
numbers. Your name and other personal identifying information will be stored in an 
electronically secure database at the New York State Psychiatric Institute. 

Patient Consent Form 
IRB Protocol # 6427 
Version 07/28/16
8
 A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as 
required by U.S. Law. This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time.
You should know that if we learn that you or someone else is threatened with serious 
harm, such as a child or an elderly person being abused, the investigators would take actions to 
protect you and others, including reporting these situations to proper authorities.  
Study Compensation  
There is no cost for participation in this study.  You will not be paid to participate in 
this study.  
In Case of Injury 
Federal regulations require that we inform you about our institution's policy with regard 
to compensation and payment for treatment of research-related injuries.  Short term emergency 
medical treatment, which has been determined to be necessary by New York State Psychiatric 
Institute's doctors, and which is within the capability of New York State Psychiatric Institute 
will be provided.  In addition, we will provide assistance in arranging follow up care in such 
instances. 
New York State Psychiatric Institute or Research Foundation for Mental Hygiene does 
not provide compensation or payment for treatment of research related injuries.  However, you 
should be aware that participation in this research does not waive any of your legal rights to 
seek such compensation through the courts. 
Your participation in this research study is completely voluntary.  You may refuse to 
participate or withdraw at any time, without loss of benefits to which you are otherwise 
entitled. The Investigator may also end your participation in this study if it is no longer in your 
best interests to participate, if you do not keep appointments or follow instructions, or if the 
study is ended prematurely. Such a decision will not affect your medical care at the New York 
State Psychiatric Institute, now or in the future.  The doctors conducting this research study are 
also responsible for your clinical care. 
Questions 
The principal investigator, Dr. Rowny, will answer to the best of his ability any 
questions you may have now or in the future about this study and research procedures. If you 
have any questions about the study procedures or about your response to the procedures, you 
may contact Dr. Rowny at (646) 774-5417. You will be given the opportunity to discuss in 
confidence any questions you may have. You will be given a copy of this consent form for you 
to keep. 
If you have any questions about your rights as a research participant, want to provide 
feedback, or have a complaint, you may call the NYSPI Institutional Review Board (IRB).(An 
IRB is a committee that protects the rights of participants in research studies). You may call 
the IRB Main Office at (646)774-7155 during regular office hours. 

Patient Consent Form 
IRB Protocol # 6427 
Version 07/28/16
9
Statement of Consent 
I voluntarily agree to participate in the research study described above. 
Signature of participant________________________________ 
Date________________ 
Printed name of participant_____________________________ 
I have discussed the proposed research with this patient including the risks, benefits, and 
alternatives to participation (including the alternative of not participating in the research). The 
participant has had an opportunity to ask questions and in my opinion, this patient is capable of 
freely consenting to participate in this research. 
Signed: ____________________________________ 
Print name:  __________________________________ 
Date_________________ 
Person Designated to Obtain Consent 
Project Director:  
Stefan B Rowny, M.D. 
Division of Brain Stimulation and Therapeutic Modulation 
New York State Psychiatric Institute 
(646) 774-5417 
Capacity to Consent Addendum 
 Protocol # 6427 
I have examined                                                       on ____________ for the purpose of 
determining whether he/she is capable of understanding the purpose, nature, risks, benefits and 
alternatives (including non-participation) of the research, making a decision about 
participation, and understanding that the decision about participation in the research will 
involve no penalty or loss of benefits to which the patient is otherwise entitled, for Dr. Stefan 
Rowny’s research project “Improving Outcomes in Geriatric Depression: Magnetic Seizure 
Therapy”.  On the basis of this examination I have arrived at the conclusion that: 
______ A.  This patient has this capacity at this time. 
______ B.   There is a question about this patient’s capacity at this time. 
______ C.   This patient clearly lacks this capacity. 
Signature 
  Date 
Printed Name 
Member of Treatment Team MD or PhD (not a co-Investigator) 

Form #PP2: HIPAA Authorization for Research 4.14.14 
New York State Psychiatric Institute (NYSPI) 
Authorization to Use or Disclose Health Information during a Research Study 
Protocol Number: 
Principal Investigator: 
Name of Study: 
Before researchers can use or share any identifiable health information (“Health Information”) about you as part of the 
above study (the “Research”), the New York State Psychiatric Institute (NYSPI) is required to obtain your authorization. You agree 
to allow the following individuals and entities to use and disclose Health Information about you as described below: 
•
New York State Psychiatric Institute (NYSPI), your doctors and other health care providers, if any, and
•
The Principal Investigator and his/her staff (together “Researchers”).   Researchers may include staff of NYSPI, the New York
State Office of Mental Health (OMH), Research Foundation for Mental Hygiene, Inc. (RFMH), and Columbia University (CU),
provided such staff is a part of the study, and
•
Providers of services for the Research at CU, NYSPI and/or RFMH, such as MRI or PET, or  Central Reference Laboratories
(NKI), if indicated in the consent form.
1.
The Health Information that may be used and/or disclosed for this Research includes:
All information collected during the Research as told to you in the Informed Consent Form.   
Health Information in your clinical research record which includes the results of physical exams, medical and 
psychiatric history, laboratory or diagnostic tests, or Health Information relating to a particular condition that is related  to 
the Research. 
Additional information may include: 
2.
The Health Information listed above may be disclosed to:
Researchers and their staff at the following organizations involved with this Research: 
The Sponsor of the Research, 
and its agents and contractors (together, “Sponsor”); and 
Representatives of regulatory and government agencies, institutional review boards, representatives of the Researchers 
and their institutions to the level needed to carry out their responsibilities related to the conduct of the research.   
Private laboratories and other persons and organizations that analyze your health information in connection with 
this study 
Other (family members or significant others, study buddies, outside agencies etc.) Specify: 
3.
By giving permission to release your Health Information as described above, you understand that your Health
Information may be disclosed to individuals or entities which are not required to comply with the federal and state privacy laws
which govern the use and disclosure of personal Health Information by NYSPI.   This means that once your Health
Bioreference Laboratory, Elmwood Park, NJ 07407


RFMH(K23)

Stefan Rowny, MD; Daniel Javitt, MD, PhD; Joan Prudic, MD



Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy 
Stefan Rowny, MD
IRB#6427

Form #PP2: HIPAA Authorization for Research 4.1.14 
Information has been disclosed to a third party which does not have to follow these laws (e.g., a drug company or the Sponsor 
of the Research), it may no longer be protected under the HIPAA or NYS Mental Hygiene Law requirements but is subject to the 
terms of the consent form and may be subject to other state or federal privacy laws or regulations.  
4.
Please note that:
•
You do not have to sign this Authorization form, but if you do not, you may not be able to participate in the study or
receive study related care.  You may change your mind at any time and for any reason. If you do so, you may no
longer be allowed to participate in the study.  If you withdraw this Authorization the research staff and the Sponsor, if this
is sponsored research, may still use or disclose Health Information containing identifying information they already have
collected about you as needed to maintain the reliability of the research.  Any request to withdraw this Authorization
must be made in writing to (enter name and contact information below):
•
While the Research is going on, you may not be allowed to review the Health Information in your clinical research
record that has been created or collected by NYSPI.   When this research has been completed you may be allowed to see
this information.  If it is needed for your care, your Health Information will be given to you or your Doctor.
5.
This Authorization does not have an end date.
6.
You will be given a copy of this form after you have signed it.
I agree to the use and disclosure of Health Information about me as described above: 
__________________________________________                _____________________ 
Signature of Participant/ Legal Representative    
Date 
______________________________________ 
Printed Name of Participant 
______________________________________ 
Relationship of Legal Representative to Participant (if applicable) 
We also ask you or your legal representative to initial the statements below: 
I have received a copy of the NYSPI/OMH Notice of Privacy Practices. 
Daniel Javitt, MD, PhD
New York State Psychiatric Institute
1051 Riverside Drive, Unit 21
New York, NY 10032