tDCS for Auditory Hallucinations in Schizophrenia
Phase: NA
Conditions: Schizophrenia
Sponsor: New York State Psychiatric Institute

Signed copy on file at IRB 
 
             v. 11/15/13 
New York State Psychiatric Institute 
Institutional Review Board 
 
November 16, 2018 
 
 
To: 
 
Dr. Daniel Javitt 
From:  
Dr. Edward Nunes, Co-Chair 
 
 
Dr. Agnes Whitaker, Co-Chair 
 
 
 
 
 
 
Subject: 
Approval Notice: Continuation Expedited per 45CFR46.110(b)(1)(f)Category 8(c) 
 
 
 
 
 
Your protocol #6662 entitled: TDCS FOR AUDITORY HALLUCINATIONS IN 
SCHIZOPHRENIAProtocol version date 11/16/2018 has been approved by the New York State 
Psychiatric Institute - Columbia University Department of Psychiatry Institutional Review Board 
from December 17, 2018 to December 16, 2019.  
 
Consent requirements: 
      √  Not applicable: Data Analysis Only 
    45CFR46.116 (d) waiver of consent for secondary data analysis 
       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.    
 
 
 
 
 
 
EN/AW/kpz4alw 

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Protocol Title:
tDCS for Auditory Hallucinations in 
Schizophrenia
Protocol Number:
6662
First Approval:
03/04/2013
Expiration Date:
12/16/2019
Version Date:
11/16/2018
Clinic:
Brain and Behavior Clinic
Contact Principal Investigator:
Daniel Javitt, MD, PHD
Email: javitt@nki.rfmh.org
Telephone: 6467745404
Co-Investigator(s):
Stefan Rowny, MD
Joshua Kantrowitz, MD
Research Chief:
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/Psychiatry
Within the division/department, what Center or group are you affiliated with, if any? 
Silvio O. Conte Center for Schizophrenia Research
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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Oded Meiron, Ph.D.
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.
Study has been completed. Data analysis continues for an R61-R33 application.A manuscript has been 
submitted to Biological Psychiatry and will be presented at ACNP 2018.
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary
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?
No
Is the study covered by a certificate of confidentiality? 
Yes
Certificate expiration date (mm/dd/yyyy) 
12/31/2021
Overall Progress

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Approved sample size
120
Total number of participants enrolled to date
75
Number of participants who have completed the study to date 
56
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
Study enrollment is ended.
Sample Demographics
Specify population
schizophrenia
Total number of participants enrolled from this population to date 
65
Gender, Racial and Ethnic Breakdown 
Caucasian: 26
African-American: 36
Hispanic: 9
Asian: 1
Other: 3
 
Male: 56
Female: 19
 
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
0
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No
Procedures

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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
   Use of Placebo or Sham Treatment
   MRI
   Use of Investigational Drug or Device
Population
Indicate which of the following populations will be included in this research
   Adults who may have impaired decision-making ability
   Medically and Psychiatrically Healthy Subjects
   Adults
   Adults over 50
   Individuals with Psychosis
Research Support/Funding
Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
Yes
Select the number of external sources of funding that will be applicable to this study
2
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol? 
Yes
Select one of the following
The grant/contract is currently funded
Source of Funding
Foundation
Sponsor
Stanley Medical Research Institute (SMRI)
Select one of the following
Multicenter(NYSPI is the lead site)
Business Office
CU
Does the grant/contract involve a subcontract? 

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No
Funding Source #2
Is the PI of the grant/contract the same as the PI of the IRB protocol? 
Yes
Select one of the following
The grant/contract is currently funded
Source of Funding
Federal
Institute/Agency
NIMH
Grant Name
Columbia Conte Center
Grant Number
P50 MH086385 
Select one of the following
Multicenter(NYSPI is the lead site)
Business Office
CU
Does the grant/contract involve a subcontract? 
No
Study Location
Indicate if the research is/will be conducted at any of the following
   NYSPI
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
The purpose of the present research is to test a potential new treatment for auditory verbal hallucinations in 
schizophrenia that uses transcranial Direct Current Stimulation (tDCS), a neurostimulation technique that 
passes an extremely weak electric current through the brain. During the treatment, two electrodes are 
positioned on the scalp above regions of the brain implicated in abnormal cortical activity associated with 
auditory verbal hallucinations in schizophrenia (1-3). Due to the directional flow of current, one electrode, 
termed “cathodal”, inhibits cortical activity, and the other, termed “anodal”, increases cortical activity. 
These electrodes will be placed such that cathodal stimulation is applied to an area associated with 
hyperactivity and anodal stimulation to an area associated with hypoactivity. One preliminary study has 

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revealed that this form of neurostimulation can alleviate auditory verbal hallucination symptoms both 
immediately following five days of treatment and up to three months after the final treatment(4). The goal of 
this study is to replicate these effects and explore the mechanisms that may underpin them.
 
45 patients with persistent auditory verbal hallucinations will be recruited to this study. Each individual will  
participate in behavioral assessments lasting up to 3 hours each and and will then be randomized to receive a 
series of active vs. sham tDCS treatments. For active treatment, patients will have the inhibitory (cathodal) 
tDCS electrode placed over left auditory cortex relative to an anodal placed over frontal cortex on the right 
side. tDCS treatments will take place for 20 min per day for 5 consecutive days.  For sham, procedures will 
be similar except that sham (inactive) tDCS treatment will be used. Assessment batteries will then be 
repeated following completion of treatment and at 1 and 3 mo following treatment. In addition, patients will 
be offered the possibility to participate in a concurrent magnetic resonance imaging (MRI) study aimed at 
evaluating the effects of tDCS on activation of auditory cortex during a auditory discrimination task as well 
as on other imaging parameters related to resting brain activity and metabolism. Patients who agree to 
participate in this MRI study will be scanned before and after active or sham tDCS.
 
In addition to hallucinating patients, we will recruit up to 20 healthy controls and 20 non-hallucinating 
patients, who will have similar assessments to the patients, but will not receive tDCS. Overall, we 
hypothesize that tDCS treatment will lead to reduction in hallucinations, improvement in auditory function, 
and change in MRI measurements so that patients more closely resemble healthy volunteers and non-
hallucinating patients.  
Background, Significance and Rationale
Background, Significance and Rationale
The term “hallucination” refers to a sensory experience that is not in accordance with reality. For example, 
many individuals who suffer from schizophrenia have the experience that people are speaking to them 
(“auditory verbal hallucinations”) even when this is not, in fact, the case. Moreover, the voices experienced 
by these individuals often include derogatory content, leading to significant emotional distress. In the worst 
case, hallucinations may “command” individuals to perform acts that are harmful to themselves of others. In 
some cases, voices are perceived coming from inside the head, although in others they are experienced as 
coming from outside. Although hallucinations respond adequately to antipsychotic medications in most 
patients with schizophrenia, for some patients the hallucinations persist and remain a significant source of 
distress. The present project is directed toward development of a new treatment for persistent auditory 
verbal hallucinations in individual with schizophrenia. 
 
One theory regarding the etiology of auditory hallucinations is that they reflect overactivity of the auditory 
region of brain (auditory cortex), especially left temporo-parietal cortex(1), and hypoactivity in the 
prefrontal cortex, especially dorsolateral and anterior cingulate regions(2, 5). In individuals with persistent 
hallucinations, these abnormalities persist despite treatment with antipsychotic medication. Transcranial 
Direct Current Stimulation (tDCS) is a relatively new technique in which small electrodes are placed over 
specific regions of the scalp and extremely low currents (1-2 mA) are applied to specific brain regions for 
up to 20 minutes. Depending upon the direction of current flow, these currents may either increase 

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(stimulate) or decrease (inhibit) activity in underlying brain regions. It has been reported that applying 
inhibitory currents over left auditory regions for 20 min per day over 5 consecutive days leads to significant, 
long-lasting reductions in auditory hallucinations (6). The present study seeks to replicate this finding and 
will utilize MRI measures of brain activity and metabolism and behavioral assessments to understand the 
underlying mechanisms.  
Specific Aims and Hypotheses
Specific Aims and Hypotheses
The aim of this study is to evaluate the effects on schizophrenia symptoms of tDCS applied with cathodal 
(inhibitory) electrode over the left temporo-parietal junction and anodal (excitatory) electrode over the left 
dorsolateral prefrontal cortex.
Our specific hypotheses are:
1. In comparison to sham, active tDCS treatment will decrease the severity of refractory auditory 
hallucinations in patients with schizophrenia
2. In comparison to sham, active tDCS treatment will decrease the severity of negative schizophrenia 
symptoms
3. In comparison to sham, active tDCS treatment will normalize auditory function as reflected in 
stronger prediction error signals in the auditory cortex during the auditory discrimination task and 
decreased baseline activity in this region. 
4. In comparison to sham, active tDCS treatment will normalize auditory function as reflected in 
reduced cerebral blood flow in auditory cortex and normalized metabolism.
5. Symptom alleviation following active tDCS treatment will be maintained over the course of 3 
months
The two control groups (AVH- and healthy controls) will serve as comparison groups for specific AIM 3 
and 4 only.
Description of Subject Population
Sample #1
Specify subject population
Schizophrenia patients with auditory hallucinations
Number of completers required to accomplish study aims
60
Projected number of subjects who will be enrolled to obtain required number of completers

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75
Age range of subject population
18-55
Sample #2
Specify subject population
Schizophrenia patients without auditory hallucinations
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
18-55
Sample #3
Specify subject population
Non-clinical control participants
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
18-55
Gender, Racial and Ethnic Breakdown
Expected racial breakdown is approximately 50% Caucasian, 16% African-American, 16% Hispanic, 16% 
Asian, and 2% other. Expected gender ratio is 50% male and 50% female.
Description of subject population
60 patients between the ages of 18 and 55 with a SCID diagnosis of schizophrenia or schizoaffective 
disorder will be enrolled in the study. All participants will exhibit refractory auditory verbal hallucinations, 
defined as the persistence of daily hallucinations without remission despite antipsychotic medication at 
adequate dosage for at least 3 months. 
In addition to the primary intervention group, two comparison groups will be studied:
1. A group of patients with minimal or no auditory hallucinations (AH-) (n=20); and
2. A group of non-clinical healthy volunteers (n=20)
These subjects will be tested using a subset of the baseline assessment battery used with AH+ patients, but 
will not receive tDCS or repeat assessments.
All patients will be receiving antipsychotic medication at the time of study entry. Patients will remain on 
their present dose of antipsychotic medication throughout the treatment interval. 
All participants will receive a physical examination and medical history evaluation in order to rule out 
disorders that might increase risks associated with tDCS, a urine toxicology screen to rule out illicit drug 
abuse, and a pregnancy test for women of childbearing capacity. After passing all screening criteria, 
participants may be removed from the study if they do not comply with study procedures, if there is a 

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change in their medical status, or if an adverse event has occurred.
Recruitment Procedures
Describe settings where recruitment will occur
Patients with schizophrenia will be recruited through the Lieber Schizophrenia Research Clinic 
and the community by our staff, all of whom will have undergone CITI and HIPAA training. 
Healthy controls will be recruited from the community.
 
How and by whom will subjects be approached and/or recruited? 
Patients will be recruited from the Lieber Schizophrenia Research Clinic as follows:
1.      Clinical psychiatrists and psychologists of each service will be informed about the study.
2.      The clinic psychiatrist will ask patients that they feel are clinically appropriate to see if he 
or she would agree to be contacted about this research protocol.
3.      If the patient agrees, then a study psychiatrist or psychologist would meet with the patient 
to describe the study and ask if the patient would be interested in participating.
4.      If the patient is interested in the study and appears to meet general eligibility criteria, the 
patient would be evaluated for capacity to give informed consent, and if they have adequate 
capacity, then provide written informed consent. 
 
Control subjects and patients from the community  will be approached after they answer advertisements.
How will the study be advertised/publicized? 
The study will be publicized to patients with schizophrenia via contact with the Lieber 
Schizophrenia Research clinic. Non-clinical control participants will be recruited by word of mouth, 
fliers, through our division's website and Craigslist.  Advertisements will be submitted to the IRB 
prior to initiation of studies.
Do you have ads/recruitment material requiring review at this time? 
No
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT01898299
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes

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Describe concurrent research involvement
#4158  Lieber Schizophrenia Research Clinic (LSRC) Umbrella Protocol
6691: MOSAIC: The Management Of Schizophrenia In Clinical Practice
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Schizophrenia patients with auditory hallucinations
Create or insert table to describe the inclusion criteria and methods to ascertain them
Criterion
Method of 
Ascertainment
1. Age between 18-55
Self report
2. SCID primary diagnosis of DSM-IV 
schizophrenia or schizoaffective disorder
SCID
3. Persistent auditory verbal hallucinations
Auditory Hallucinations 
Rating Scale mean item 
score >2 and stable 
mean score >2 or within 
25% of screening score 
at baseline
4. Right handed 
Edinburgh Handedness 
Questionnaire 
5. Stable antipsychotic medication for >4 weeks
Physician 
evaluation/Psychiatric 
history 
6. Normal hearing
Physician evaluation 
7. If female and not infertile, must agree to use one 
of the following forms of contraception for the 
duration of study participation: systemic hormonal 
treatment, an IUD which was implanted at least 2 
months prior to screening, or “double-barrier” 
contraception.
Physician evaluation
8. Willing/capacity to provide informed consent
Physician evaluation 
Create or insert table to describe the exclusion criteria and methods to ascertain them
Criterion
Method of 
Ascertainment

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1. Substance dependence or abuse (excluding nicotine) 
in the past 90 days
Physician 
evaluation
2.Current significant laboratory abnormality* 
screening labs 
 3. History of seizure, epilepsy in self or first degree 
relatives, stroke, brain surgery, head injury with loss of 
consciousness > 1 hour or clear cognitive sequelae, 
intracranial metal implants, known structural brain 
lesion, devices that may be affected by tDCS 
(pacemaker, medication pump, cochlear implant, 
implanted brain stimulator)
 Physician 
evaluation/Medical 
history
4. Frequent and persistent migraines
Physician 
evaluation/Medical 
history 
5. History of adverse reaction to neurostimulation or 
open skin wounds that would preclude safe placement of 
tDCS electrodes
Self report 
6. Participation in study of investigational 
medication/device within 4 weeks
Self report 
7. Current use of medications known to lower
seizure threshold (Lithium, Theophylline, Tricyclic 
antidepressants, Buproprion >450 mg/day and Clozapine 
>600 mg/day, brand name and generic 
methylphenidate/mixed amphetamine salts)
Physician 
evaluation/Medical 
history 
8.If female, pregnant or breast feeding at the time of 
screening
Urine pregnancy 
test and self report
9. For MRI study only: Claustrophobia or metal 
implants or paramagnetic objects contained within the 
body which may interfere with the MRI scan, as 
determined according to the guidelines set forth in the 
following reference book: “Guide to MR procedures and 
metallic objects” Shellock, PhD, Lippincott-Raven 
press, NY 1998.
History, interview
*Note: Clinically significant laboratory abnormality refers to patient lab results that fall significantly outside 
the established ranges, may be indicative of the presence of a medical condition, and are not thought to 
reflect an artifact or routine lab error (e.g., hemolysis). Results of laboratory tests are reviewed by the study 
physician prior to any treatment. Abnormal lab results of clinical significance that cannot be resolved (e.g., 
by repeating the test to rule out laboratory error or poor quality of the original sample) will lead to exclusion 
from the study. Abnormal laboratory values associated with known, chronic, stable medical conditions will 
not be considered exclusionary unless the condition would increase risk of study participation. 

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Inclusion/Exclusion Criteria #2
Name the subject group/sub sample
Schizophrenia patients without auditory hallucinations
Create or insert table to describe the inclusion criteria and methods to ascertain them 
Criterion
Method of Ascertainment
1. Age between 18-55
Self report
2. SCID primary diagnosis of DSM-IV 
schizophrenia or schizoaffective
SCID
3. Right handed
Edinburgh Handedness 
Questionnaire 
4. Normal hearing
Physician evaluation 
5. Stable course of antipsychotic medication for 
>1 month
Physician 
evaluation/Psychiatric 
history 
6. Use of effective method of birth control for 
women of childbearing capacity
Physician evaluation 
7. Willing/capacity to provide informed consent
Physician evaluation 
8. Signed HIPAA authorization
Physician evaluation 
Create or insert table to describe the exclusion criteria and methods to ascertain them 
Criteria
Method of 
Ascertainmment
1. Current persistent auditory verbal hallucinations
Auditory 
Hallucinations 
Rating Scale mean 
item score >0
2. Current or past history of substance dependence 
(excluding nicotine)
Physician 
evaluation
3. Substance abuse (excluding nicotine) within last 90 
days
Physician 
evaluation/Urine 
toxicology screen 
4. Current diagnosis of any other Axis I disorder
SCID/Psychiatric 
history 
5. History of seizure, epilepsy in self or first degree 
relatives, stroke, brain surgery, head injury, intracranial 
metal implants, known structural brain lesion, devices 
that may be affected by tDCS (pacemaker, medication 
pump, cochlear implant, implanted brain stimulator)
Physician 
evaluation/Medical 
history 

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6. Frequent and persistent migraines
Physician 
evaluation/Medical 
history 
7. Participation in study of investigational 
medication/device within 6 weeks
Self report 
8. Current use of medications known to lower seizure 
threshold (benzodiazepines, mood stabilizers)
Physician 
evaluation/Medical 
history 
9. Pregnancy
Urine pregnancy 
test 
10. Women who are breast-feeding
Self report 
11. For MRI study only: Claustrophobia or metal 
implants or paramagnetic objects contained within the 
body which may interfere with the MRI scan, as 
determined according to the guidelines set forth in the 
following reference book: “Guide to MR procedures and 
metallic objects” Shellock, PhD, Lippincott-Raven 
press, NY 1998.
 History, interview
Inclusion/Exclusion Criteria #3
Name the subject group/sub sample
Non-clinical control participants
Create or insert table to describe the inclusion criteria and methods to ascertain them 
Criterion
Method of 
Ascertainment
1. Age between 18-55
Self report
2. Right handed
Edinburgh Handedness 
Questionnaire
3. Normal hearing
Physician evaluation 
4. Use of effective method of birth control for 
women of childbearing capacity
Physician evaluation 
5. Willing to provide informed consent
Physician evaluation 
6. Signed HIPAA authorization
Physician evaluation 
Create or insert table to describe the exclusion criteria and methods to ascertain them 
Criterion
Method of 
Ascertainment

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1. Current or past history of substance dependence 
(excluding nicotine)
Physician 
evaluation
2. Substance abuse (excluding nicotine) within last 90 
days
Physician 
evaluation/Urine 
toxicology screen
3. Current diagnosis of any Axis I disorder
SCID-
NP/Psychiatric 
history 
4. History of seizure, epilepsy in self or first degree 
relatives, stroke brain surgery, head injury, intracranial 
metal implants, known structural brain lesion, devices 
that may be affected by tDCS (pacemaker, medication 
pump, cochlear implant, implanted brain stimulator)
Physician 
evaluation/Medical 
history 
5. Frequent or persistent migraines
Physician 
evaluation/Medical 
history 
6. Participation in study of investigational 
medication/device within 6 weeks
Self report 
7. Current use of medications known to lower the 
seizure threshold
Physician 
evaluation/Medical 
history 
8. Pregnancy
Urine pregnancy 
test 
9. Women who are breast-feeding
Self report 
10. For MRI study only: Claustrophobia or metal 
implants or paramagnetic objects contained within 
the body which may interfere with the MRI scan, as 
determined according to the guidelines set forth in 
the following reference book: “Guide to MR 
procedures and metallic objects” Shellock, PhD, 
Lippincott-Raven press, NY 1998.
 History, 
interview
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
No
Waiver of documentation of consent 

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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 
All staff members involved in screening participants will have undergone HIPAA and CITI training. Prior to 
screening, potential participants will be asked whether they are willing to answer questions about their 
medical and psychiatric history. Screening will only proceed once consent has been given.
Describe Study Consent Procedures
Study consent will be obtained by investigators only. All investigators will have undergone HIPAA and 
CITI training, and will be familiar with tDCS. The investigator will explain all study procedures and 
associated risks prior to requesting consent. When recruiting patients with schizophrenia, an M.D. who is 
not affiliated with the study will ask the patient questions about the study procedures and risks in order to 
determine whether the patient understands the study and has the capacity to provide consent.
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
Girgis, Ragy, MD
Javitt, Daniel, MD
Kantrowitz, Joshua, MD
Type in the name(s) not found in the above list
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 M.D. who is unaffiliated but familiar with the study will ask potential participants who have been 
diagnosed with schizophrenia questions about the study procedures and associated risks in order to 
determine whether the patient understands the study and has the capacity to provide consent.

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Study Procedures
Describe the procedures required for this study
Overview
 
AH + Sample
 
The treatment portion of this study will follow a double-blind parallel arm design in which patients, raters 
and investigators will be blinded with respect to condition assignment. All personnel will have undergone 
HIPAA and CITI training. Following a clinical evaluation to determine eligibility, patients will be assigned 
to either the active or the sham condition. In the active condition, patients will receive cathodal stimulation 
to the left temporo-parietal junction and anodal stimulation to the left dorsolateral prefrontal cortex at 2mA 
X 20 min in each session. In the sham condition, electrodes will be placed over the same regions, but current 
will be applied under a “sham” approach in which currents are initially ramped up over 30 s as in the active 
condition, but then immediately ramped down. Prior experience has shown that subjects do not distinguish 
the active and sham conditions. Patients will participate in two daily sessions of 20 minutes each for 5 
consecutive weekdays. Auditory hallucinations as determined by the Auditory Hallucinations Rating Scale 
(AHRS) and the five dimensions of schizophrenia symptoms assessed in the Positive and Negative 
Syndrome Scale (PANSS) will be assessed at baseline, immediately following the final treatment, and at 1- 
and 3-month follow-up timepoints. AHRS will be repeated prior to first treatment session. All subjects will 
be assessed prior to and following initiation of 5-d treatment period using a neurophysiological battery 
sensitive to auditory dysfunction in schizophrenia, and neuropsychological tests of auditory and general 
neurocognitive impairment. The neurophysiological impact of tDCS will be assessed by MRI procedures 
described below at baseline and immediately following the final treatment. MRI sessions are optional for 
AVH+ patients.
 
Comparison Samples
 
AH- patients and non-clinical control participants will first undergo clinical evaluation to determine 
eligibility according to their sample’s respective inclusion/exclusion criteria before participating in a 
baseline assessment session. Baseline assessments for the AH- patients will include the same 
neurophysiological battery sensitive to auditory dysfunction, neuropsychological tests auditory and general 
neurocognitive impairment, MRI  procedures that the AH+ patient sample receives. Non-clinical control 
participants will only take part in the assessment of auditory function and MRI procedure.
 
Evaluation
 
After the patient signs the informed consent form and the HIPAA authorization, he/she will undergo clinical 
evaluation to determine study eligibility. All participants will receive medical assessments from an MD 
(medical history, physical examination, urine pregnancy test and toxicology) and either the SCID 
(schizophrenia patients) from an RN or SCID-NP (non-clinical controls) from an MA level psychologist. 
All patients with schizophrenia will also undergo a psychiatric history assessment with an MD. Patients in 
the AH+ sample will undergo additional medical assessments including blood draw, urinalysis and ECG to 
ensure tDCS safety. A urine pregnancy will be done during screening and prior to the first tDCS session (on 
Day 1). 

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Assessments
 
Baseline assessment will consist of behavioral assessments of auditory function as described below. All 
assessments will be performed by a rater blind to condition assignment. Symptoms will be assessed by an 
MA level psychologist. Neuropsychological testing will be conducted by a trained, BA level research 
assistant.
 
Behavioral Measures
 
Behavioral assessments will consist of ratings scales for both AH+ and AH- patients, and a hearing test for 
all participants including both patients and non-clinical controls. Ratings scales will include the Positive and 
Negative Syndrome Scale (PANSS), Auditory Hallucinations Rating Scale (AHRS), the Measurement and 
Treatment Research to Improve Cognition in Schizophrenia (MATRICS) neuropsychological battery, and 
the Self-report Quality of Life Scale (SQLS) (7). The hearing test completed by all patients and non-clinical 
controls will consist of a computerized tone matching task (TMT) which will assess their ability to match 
tones following brief delay (8, 9)
Magnetic Resonance Imaging (MRI)
Subjects who consent for the optional MRI component will undergo MRI scanning, which includes 
structural 3-Tesla MRI scans and task-based fMRI scans and may include resting-state fMRI, resting-state 
ASL, magnetic resonance spectroscopy, and diffusion tensor imaging. None of the imaging modalities used 
in the study will include exogenous contrasts. Total scanning time will typically be around 2 hours and will 
not exceed 3 hours. 
   MRI scans will be performed immediately before and after the treatment period with active or sham tDCS 
in AVH+ patients. Comparison AVH- patients and healthy participants will also undergo MRI scanning 
despite not receiving tDCS. On the day of MRI scanning, subjects will be accompanied to the MRI suite at 
the NYSPI or Neurological Institute (depending on availability). The subject will be placed in a supine 
position on the camera table. Head will be positioned and a plastic head-holder will be used to decrease 
head movement during the scan. A bite bar (a soft but firm mouthpiece) will also be offered to the subjects 
to prevent excessive movement. Participants may or may not bite down on the bite bar. A new disposable 
cover for the bite bar will be used for every new participant. The participants will be given foam earplugs to 
reduce the noise of the MRI as well as a MRI-compatible hand held response pad for responding to the task 
(multi-button response units or mouse or a similar device). The tasks will be projected from an Insight liquid 
crystal display (LCD) projector zoomed to a screen inside the MR suite or viewed through dual channel 
binocular goggles (Silent Vision SV-2600; Avotec, Inc.). All subjects will undergo a structural MRI scan at 
the beginning of the session to allow for anatomical co-registration. Women will have urine pregnancy 
testing on each MRI scan day.
MRI Screening 
Before inclusion in the MRI experiment, all subjects will be screened to ensure their eligibility for MRI 
scanning. The screening questionnaire includes questions regarding inclusion/exclusion criteria, including 
the presence of ferromagnetic implants, pubertal status, and pregnancy. Questions will be asked to 
determine if girls/women are post-menarche or pre-menopausal. Menarche will be defined as the onset of 

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menstruation, and menopause will be defined as the offset of menstruation. Females will be asked during the 
screening process if they are currently pregnant. Questions regarding ferromagnetic implants will determine 
whether or not the subject will be at any risk being in the scanner. If the subject has any metallic implants 
(i.e. metal heart valve, aortic clips, etc.) that are unsuitable for the scanner, the subject will not be included 
in our study. Inclusion and exclusion in our study will be determined by the PI and co-PIs in this study.  
Further screening will be done via the New York State Psychiatric Institute – Dept. of Psychiatry MRI 
Metal Screening Questionnaire. A 38-item questionnaire that was developed by the MRI Unit will be 
administered to every subject before they enter the MRI scanner. This questionnaire asks specifically about 
metallic implants and past experiences with metal to further ascertain any possible risks the person may 
incur by entering the scanner. Again, if any metallic implants are detected that are unsuitable for the 
scanner, the subject will not be included in our study. All precautions will be taken for the safety of the 
participants.
fMRI Task Description (auditory discrimination task)
Participants will perform an auditory discrimination task during the fMRI scans. This task is designed to 
detect activation in the auditory cortex and other language-related areas, without interference from the 
scanner noise, regardless whether the activation is induced by external acoustic stimulation or by internally 
generated or spontaneous processes. Subjects will be explained that they will hear recordings of spoken 
sentences through headphones at random intervals while in the scanner. Each stimulus will be presented 
over an otherwise silent epoch, which will be followed by a short noisy imaging acquisition period. Right 
when the latter finishes, they will be asked if they heard any voices immediately before the scanner noise 
started and they would need press a button to indicate so. They will be instructed that the content of the 
sentences will be explicit in some cases and they will listen to the recordings before the scanning session. 
Before each of the two sessions in the scanner, participants will have a training session in a computer 
outside of the scanner. The training session will last about 30 minutes.
Although our MRI Scans are for research purposes (and not clinical purposes), a credentialed, board-
certified radiologist will perform a clinical reading for gross structural abnormalities on every MRI within 1 
month of scanning. If anything clinically significant is found, Dr. Javitt will be notified immediately, and an 
appropriate clinical referral will be provided to the participant. In the case that an MRI technician or other 
member of the research team suspects that an MRI scan suggests evidence of a significant lesion, the PI will 
be notified immediately. If the reading yields a finding of immediate clinical concern, the radiologist will 
provide an oral report followed by a written note to the PI and Director of the MRI unit. A written report 
will be provided within two weeks of the oral report. Results of the MRI will be provided to the volunteers 
by a study physician. Volunteers can opt to receive a letter regarding the results of the MRI on the consent 
forms. Participants requesting a letter will receive one using the language provided by the IRB.
 
 
Treatment
 
Only patients in the AH+ sample will receive tDCS treatment. Prior to the first treatment, all female subjects 
will receive a pregnancy test. Stimulation will be performed using a battery-driven BrainStim SYS 
(Brainvision LLC, Germany), and transferred through two 7x5 cm sponge electrodes soaked in a saline 
solution (0.9% NaCl). In accordance with a recent tDCS study (21) showing beneficial effects of tDCS 
stimulation in reducing AVH in hallucinating schizophrenia patients, we will use a similar stimulation 

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montage. In the active tDCS condition the cathodal electrode will be placed over the left temporoparietal 
junction, and the anodal electrode will be placed over right DLPFC. In accordance with recent studies of 
tDCS in other psychiatric or neurological illnesses(22-24), the stimulation level will be set at 2 mA for 20 
minutes. Stimulation sessions will be conducted twice a day on 5 consecutive weekdays. Each daily session 
will be separated by at least 3 hours. In sham stimulation, electrodes are located in the same positions as in 
active stimulation and the same fade in/fade out ramp will be applied and the constant current will last only 
30 s. Small current pulses will also occur infrequently (every 550 ms, 110 mA over 15 ms) through the 
remainder of the 20-minute session to produce similar stimulation sensation between conditions. During the 
treatment sessions, subjects will be allowed to watch a silent movie or read material of their choice. 
Treatments will be administered by a trained, BA-level research assistant under supervision of an MD.  The 
RA will undergo a progression of graduating steps consisting of observation, implementation under 
supervision, and implementation with guidance. 

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Safety:
We will monitor for potential adverse events of tDCS with the Wong-Baker Faces Pain Rating Scale 
(WBFPRS, Figure). The WBFPRS is readily understood by patients and provides general evaluation of discomfort. 
Additionally, we will monitor discomfort and potential objective adverse effects of tDCS (e.g. skin 
redness) as suggested by "Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic 
review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J 
Neuropsychopharmacol. 2011;14:1133-45: (Figure 2).  Any score rated at a 3 or greater in severity will 
require immediate evaluation by a qualified member of the clinical team (Dr. Stefan Rowny). Both are 
familiar with Brain stimulation procedures.   
In these cases, the psychiatrist will check in via phone with the subject the following day, and then as 
clinically indicated. 
 
Additionally, subjects will receive the CGI-I scale prior to each treatment session to evaluate clinical 
stability. Additionally, at baseline 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. 
 
Post-treatment Assessments
 
Immediately following completion of last treatment, patients in the AH+ sample will have 1 tube of blood 
drawn for BDNF levels. Within 1 week following completion of treatment, patients will have repeat of 
baseline behavioral and ERP methods. Behavioral assessments will also be repeated at 1- and 3-month 
follow-up timepoints. Response to treatment will be defined as >15% reduction in AHRS score. After the 
completion of the 3 month visit, subjects will be offered the opportunity to do one week of optional, 
open label active treatment using identical procedures to the blinded treatment. Subjects will be seen 
once after the week of open treatment for a follow-up visit 
 
Schedule of Events
 
Please see attached table.
 
Comparison Samples
Participants in the AH- and non-clinical control samples will take part in a baseline assessment session only. 
AH- patients will be assessed via the SCID, AHRS, PANSS/SQLS, MATRICS/TMT, and ERP procedure. 
Non-clinical control participants will be assessed via the SCID-NP procedure. 
 
 
 Genetics Blood draw:
Only AVH+ subjects will be asked to participate in the genetics blood draw. 
 

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tDCS is thought to work in part by stimulation of BDNF( Fritsch B, Reis J, Martinowich K, Schambra HM, 
Ji Y, Cohen LG, Lu B. Direct current stimulation promotes BDNF-dependent synaptic plasticity: potential 
implications for motor learning. Neuron. 2010;66:198-204. PM#2864780). Furthermore, plasma BDNF is 
known to correlate with CSF BDNF (Pillai A, Kale A, Joshi S, Naphade N, Raju MS, Nasrallah H, Mahadik 
SP. Decreased BDNF levels in CSF of drug-naive first-episode psychotic subjects: correlation with plasma 
BDNF and psychopathology. Int J Neuropsychopharmacol. 2010;13:535-9) and so represents an appropriate 
reflection of potential effects of tDCS on CNS plasticity. We predict that an increase in plasma BDNF may 
serve as a marker of "adequate" tDCS. D-serine is an endogenous modulator of NMDAR function that is 
known to modulate dendritic architecture in brain (Balu DT, Coyle JT. Neuronal D-serine regulates 
dendritic architecture in the somatosensory cortex. Neurosci Lett. 2012;517:77-81. PM#3400345). D-serine 
synthesis is dynamically regulated by compounds (e.g. nitric oxide) that also affect brain plasticity (1. Darra 
E, Ebner FH, Shoji K, Suzuki H, Mariotto S. Dual cross-talk between nitric oxide and D-serine in astrocytes 
and neurons in the brain. Cent Nerv Syst Agents Med Chem. 2009;9:289-94) . Although there is less 
literature regarding effects of tDCS on D-serine regulation, nevetheless addition of this measurement (which 
is done by the Cooper lab) adds little expense to the study and does not require additional phlebotomy. We 
postulate that successful tDCS will be accompanied by increased D-serine release and possibly dendritic 
rearrangement in brain, and will be reflected in peripheral (plasma) D-serine concentrations.
 
 
In reviewing the literature, we note that there is also evidence that BDNF gene polymorphisms affect 
response to tDCS (Antal A, Chaieb L, Moliadze V, Monte-Silva K, Poreisz C, 
Thirugnanasambandam N, Nitsche MA, Shoukier M, Ludwig H, Paulus W. Brain-derived 
neurotrophic factor (BDNF) gene polymorphisms shape cortical plasticity in humans. Brain Stimul. 
2010;3:230-7). It has also been demonstrated that individuals with common polymorphisms of the 
BDNF gene may show differential response to tDCS enhancement of brain plasticity. Thus, for both 
facilitatory tDCS (24 subjects, 10 heterozygotes) and inhibitory tDCS (19 subjects, 8 heterozygotes), 
carriers of the Val66Met allele displayed enhanced plasticity. In the present study, we will perform a 
secondary analysis to evaluate whether Val66 Met carriers show preferential response to tDCS 
treatment.
 
 
 
You can upload charts or diagrams if any
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
Treatment Termination
 
Study participation for patients in the AH+ sample will be terminated for subjects with a CGI-I worsening 
of 2 or greater for two consecutive days, or a CGI-S of 6 or 7 at anytime.
 

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Participants in all samples may choose to terminate their involvement at any time.  
Blood and other Biological Samples
Please create or insert a table describing the proposed collection of blood or other biological specimens
Blood samples will be drawn for patients in the AH+ sample only. No blood or biological samples will be 
collected from participants in the AH- or non-clinical control samples.
 
12 cc at screening will be drawn for blood work-up (Chem 20, Thyroid function) to determine tDCS 
treatment safety.
30 cc tube of blood will be collected for D-serine and BDNF assessment and genetics (optional).
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
SCID: 60 min
SCID-NP: 30 min
AHRS: 20 min
PANSS: 30 min
MATRICS battery (without SC): 1 hr
Tone Matching Test: 20 min 
SQLS: 15 min
EEG for ERP procedures: 3 hrs 
Wong-Baker Faces Pain Rating Scale 1 minute
CGI-S  and CGI-I 5 minutes
Brunoni safety scale 5 minutes
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

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Name of the device
BrainStim SYS
Manufacturer and other information
Brain Vision LLC
Approval Status
IDE is approved
IDE#
CE Reg#MED30003 
Who holds the IDE/IDE sponsor?
Other
Enter Name
Brain Vision LLC
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
No
Treatment to be provided at the end of the study
None. This treatment will be added to standard-of-care treatment for persistent auditory hallucinations 
which consists of use of antipsychotic medications.
Clinical Treatment Alternatives
Clinical treatment alternatives
Standard-of-care treatment for persistent auditory hallucinations consists of use of antipsychotic 
medications.
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
MRI
 
There are no known risks to the use of MRI per se. However, three areas of concern are addressed in the 
next section. The first is the safety risk posed by the attraction of ferromagnetic metal objects by high 
strength magnetic fields. The second is the discomfort some subjects experience during confinement within 
the bore of the MRI system. The third is the loud noise made by the gradients during imaging. These risks 
occur for all clinical MRI exams and are not increased by the proposed research. The images obtained from 
structural and functional scanning are automatically transferred from the scanner to a workstation that strips 
potentially identifying data from the image headers, writes the data as image volumes identified by study 

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number only, and stores the data on our password-protected server in a directory only accessible by the 
study investigators. All MRI studies follow guidelines set by the FDA with regard to specific absorption 
ratio (SAR), limits on gradient slew rate (dB/dt), and noise. Having ascertained the absence of implanted 
metal foreign objects using the aforementioned screening form, subjects and staff remove all other metal 
objects, including clothing with metal clasps, before entering the magnet room. The magnetic properties of 
unknown material are tested outside the magnet room with a strong permanent magnet. Participants and 
staff are also instructed to enter the magnet room slowly and to pause at the entrance to determine if any 
items on their person may be pulling toward the magnet. Participants wear insert earplugs during scanning 
to reduce noise levels below FDA limits. General Electric engineers have recently measured the sound 
levels within our scanners and have determined that it is compliant with FDA guidelines.
    Some people have reported sensations during MRI scans, such as "tingling" or "twitching" (or, very 
rarely, a painful sensation), which are caused by changes in the magnetic field that can stimulate nerves in 
the body. In our experience, no one has had sensations from the MRI that did not stop when the scanning 
stopped. An acute risk of burns to the skin is presented by medicinal skin patches, and participants will be 
asked to remove patches before entering the scanner. Some participants may feel uncomfortable or confined 
once positioned within the bore of the MRI system and it may cause some subjects to feel anxious.
 
 
Evaluation
 
Patients with schizophrenia may experience some discomfort as a result of questions asked during the 
psychiatric evaluation, but this should be comparable to their experiences in standard care. For participants 
recruited for the AH+ sample who receive a blood draw: occasionally, redness or a bruise may develop at 
the site where blood was drawn. If this occurs, it will usually disappear in a few days. Some people become 
dizzy and faint when their blood is drawn.
 
tDCS (AH+ Sample Only)
 
Since the development of tDCS in the 1960’s, hundreds of subjects have participated in studies and received 
tDCS without any adverse effects. There has been no evidence of neuronal damage induced by tDCS: in two 
evaluations, Nitsche and colleagues (25, 26) found no elevation of neurone-specific enolase (sensitive 
marker of neuronal damage). McCreery et al.,(27) demonstrated that current densities below 25mA/cm2 do 
not induce brain tissue damage even by applying high-frequency stimulation over several hours. In our 
protocol, we stimulate with a maximum current density of 0.057 mA/cm2, a thousand fold below this limit. 
Duration of stimulation is an additional factor contributing to potential tissue damage, which has been 
detected at a minimum total charge of 216 C/cm2 (28). (Total charge=current density x stimulation 
duration.) This protocol exposes subjects to maximum total charges of 0.022 C/cm2, which is far below the 
established safety threshold. Iyer et al. (29) demonstrated the safety of tDCS applied at 1mA and 2mA for 
20 minutes to normal subjects and noted some enhancement of verbal fluency after 2mA of stimulation, but 
no adverse events. A recent study (30) has demonstrated the safety of 1mA of cathodal tDCS for 20 min in 
patients with refractory epilepsy. The authors concluded that tDCS does not induce seizures and may have 
an anti-epileptic effect. Fregni et al, in May 2006 (31), report that patients suffering from central pain 
secondary to traumatic spinal cord injury safely tolerated tDCS at 2mA for 5 consecutive days, 20 min 
daily, with significant pain improvement but no significant influence on cognitive performance before and 

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after treatment.
Some participants reported redness, itching, and mild scabbing of the skin under the electrodes during and 
after tDCS. Some subjects have reported a sunburn like sensation under the electrodes while current was 
turned on. This has sometimes persisted for an hour or more after the current was turned off. Mild scabbing 
has also been observed under an electrode, which resolved after a few days. Both of these events (sunburn 
like sensation and scabbing) appear to be related to drying out of the sponge electrodes, which we learned 
from another investigator working with tDCS. Since then we have kept the sponges sufficiently moist, and 
irritation has been minimal or absent, while scabbing has not recurred.
Some subjects may also experience mild nausea during or after the stimulation. In a study involving one-
hundred and two subjects, 2.9% of the participants reported feeling nauseous after receiving tDCS (32).
Reported side effects of tDCS include reddening of the skin under the electrodes (reported in two subjects 
with recently shaved heads) and itching under the electrode sites while the current was turned on. 
 
Genetics: there are potential dangers in releasing DNA information, such as jeopardy to insurability (risk to  
ability to obtain insurance), discrimination against employers, landlords and others. 
 
 
Describe procedures for minimizing risks
tDCS
 
Routine safety procedures are in place to screen subjects prior to scanning, maintain security of the 
restricted access areas, and ensure that system security features are in good working order.
To minimize chemical reactions at the electrode-skin interface, non-metallic, conductive rubber electrodes, 
covered completely with saline-soaked sponges will be used, as recommended by Nitsche and Paulus, 2000 
(33).
Electrode sponges will be kept moist in order to avoid skin irritation.
A research physician will be present at all times to monitor patient safety.
Operation of cellular (wireless) devices, telephones, or two-way radios may produce changes in device 
output, and thus should not be used in close proximity (< 1m). 
We do not apply electrodes over broken or irritated skin. 
The use of other stimulation electrodes during the treatment period will be avoided. 
Lead wires are configured so that they cannot be plugged into power outlets such as wall sockets and line 
cord receptacles. 
 
 
MRI
 
In order to minimize risks and discomforts to participants, we will:
- Screen for metallic devices, implants and other contraindications to scanning by using a screening 
questionnaire.

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- Exclude pregnant subjects and conduct a urine pregnancy test prior to scanning.
- We will also exclude subjects with claustrophobia. We will reduce this potential adverse reaction by 
discussing the procedure prior to entry into the magnet room, by providing the subject with a mirror through 
which they can look out into the room, and by communicating with the subject over the intercom. If a 
subject continues to feel uncomfortable, the imaging procedure is terminated and the subject is removed 
from the magnet.
- Staff will provide adequate medical, safety monitoring and observation during scanning.
- Our staff will be available to provide support, reduce anxiety, optimize the comfort of the subject and 
remove the subject from the machine if requested.
 
 
Evaluation
 
Psychiatric evaluations will be performed by a trained clinical rater with patient experience. Blood draws 
will be performed by a trained phlebotomist.
 
Genetics: blood samples will be coded.  No personal identification will link subjects with the blood sample, 
and the genetic information will not be made available to anyone (including the subject and their physician). 
We will apply for a certificate of confidentiality as an additional protection.
 
 
 
Methods to Protect Confidentiality
Describe methods to protect confidentiality
All data (written and electronic) will be coded by number. Personal identifying information will be sorted in 
an electronically secure database at New York Psychiatric Institute. A master list matching subjects with 
codes will be kept under lock and key, separate from any research records or the computer database, with 
access restricted to research staff, to the extent permitted by law. Only staff directly involved in this project 
will have access to the master list linking subject names to code numbers. In the informed consent form, 
subjects are told that the information they provide and all findings of testing will be kept strictly 
confidential, with access limited to the research staff, and possibly state or federal regulatory personnel. 
Subject data will be kept in a computer, but the subject’s name will not appear in this database. The 
information will only be linked to a code number assigned for the purpose 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?
Yes, we have already received a Certificate of Confidentiality
Direct Benefits to Subjects  

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Direct Benefits to Subjects
Participants may experience no direct benefits from their involvement in this study.
For schizophrenia patients receiving treatment, in one prior study using this procedure , a 30% reduction in 
hallucination severity was observed along with a significant reduction in Positive and Negative Symptoms.
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
AVH+ subjects will be paid $50 for Baseline, Post Treatment, 1 month, and 3 month visits and $100 for 5 
TDCS/EEG visits. If they complete the optional ERP sessions, they will be paid an additional 15 dollars an 
hour (for approximately 3 hours per session for two sessions), an additional $20 for optional 
genetic/biomarker blood draws, and an additional $200 if they complete all optional MRI procedures. Total 
payment will be  $1040 if they complete the entire study and the optional ERP and MRI components.  
Reasonable transportation costs (such as subway/bus fare or local taxi fare) will be reimbursed.
 
Control subjects (both patients and healthy control groups) will be paid $15 an hour, and approximately $90 
for the entire study. They will additionally receive $200 if they participate in the MRI study.
 
References
References
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hallucinations in schizophrenia. Nature. 1995;378(6553):176-9. Epub 1995/11/09.
2. Lawrie SM. Reduced frontotemporal functional connectivity in schizophrenia associated with auditory 
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3. Sanfilipo M. Volumetric measure of the frontal and temporal lobe regions in schizophrenia: Relationship 
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measure for people with schizophrenia: the SQLS. The British journal of psychiatry : the journal of mental 
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15. Friedman T, Sehatpour P, Dias E, Perrin M, Javitt DC. Differential relationships of mismatch negativity 
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16. Light GA, Swerdlow NR, Rissling AJ, Radant A, Sugar CA, Sprock J, et al. Characterization of 
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randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment 
of major depression. The international journal of neuropsychopharmacology / official scientific journal of 
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bifocal tDCS as an interventional treatment for refractory schizophrenia. Brain Stimul. 2012;5(3):431-2. 
Epub 2011/11/01.
25. Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex 
stimulation in humans. Neurology. 2001;57(10):1899-901. Epub 2001/11/28.
26. Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct 
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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
Nathan Kline Institute
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Stanley Foundation and the NIMH
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your treating psychiatrist
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tDCS for Auditory Hallucinations in Schizophrenia
Daniel Javitt MD, PhD
6662

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, M.D, Ph.D, 1051 Riverside Dr-Unit 42, New York, NY 10032