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CTRI Number  CTRI/2021/07/034759 [Registered on: 12/07/2021] Trial Registered Prospectively
Last Modified On: 09/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness Of HDtDCS In Cognitive And Negative Symptoms Of Schizophrenia measured Using fMRI 
Scientific Title of Study   Effectiveness Of Adjuvant HDtDCS On Functional Connectivity On Cognitive And Negative Symptoms Of Schizophrenia : A Controlled fMRI Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhawna Yadav 
Designation  Junior Resident 
Affiliation  Central Institute Of Psychiatry 
Address  Room no 117 Al-Razi Hostel Central Institute Of Psychiatry, Kanke , Ranchi

Ranchi
JHARKHAND
834006
India 
Phone  9650618113  
Fax    
Email  bhawnayadav1712@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nishant Goyal 
Designation  Associate Professor 
Affiliation  Central Institute Of Psychiatry 
Address  In-charge fMRI Centre,K S Mani Centre for Cognitive Neurosciences and Erna Hoch Centre for Child and Adolescent Psychiatry,Central Institute Of Psychiatry

Ranchi
JHARKHAND
834006
India 
Phone  9431171162  
Fax    
Email  psynishant@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishant Goyal 
Designation  Associate Professor 
Affiliation  Central Institute Of Psychiatry 
Address  In-charge fMRI Centre, K S Mani Centre for Cognitive Neurosciences and Erna Hoch Centre for Child and Adolescent Psychiatry, Central Institute Of Psychiatry

Ranchi
JHARKHAND
834006
India 
Phone  9431171162  
Fax    
Email  psynishant@gmail.com  
 
Source of Monetary or Material Support  
Central Institute Of Psychiatry, Kanke , Ranchi, Jharkhand, India 
 
Primary Sponsor  
Name  Central Institute Of Psychiatry 
Address  Kanke,Ranchi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhawna Yadav  Central Institute Of Psychiatry  fMRI Centre and K S Mani Centre for Cognitive Neurosciences
Ranchi
JHARKHAND 		 9650618113

bhawnayadav1712@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE,CIP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Definition Trans-Cranial Direct Current Stimulation (HDtDCS)  The central active anode electrode will be placed over the medial prefrontal Cortex/ d ACC (FZ) which will be surrounded by 4 return (Cathodal) electrodes placed at FPZ, CZ, F3, F4 with diameter of 3.5 cm which will determines the modulation area, which were connected to a four-to-one wire adaptor for the DC stimulator. Altogether 5 sintered Ag/AgCl ring electrodes will be stabilized with plastic holders filled with EEG conducting gel place. The anode electrode will be placed over FZ (using EEG 10/20 system) and 2mA current will be applied for 20 minutes. Twice a day session with an inter-stimulation time of 4 hours for 10 days equaling 20 sessions. 
Comparator Agent  Sham High Definition Transcranial Direct Current Stimulation (HDtDCS)  Active sham condition will be given with shunting of current through the scalp which gives equivalent sensation as compared to active condition but with little or no cortical modulatory effects. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diagnosis of Schizophrenia using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization,1992)
2.Duration of illness to be more than or equal to two years.
3.Age between 18- 60 years of either sex
4.The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score of more than 15
5.Scale for Assessment of Negative Symptoms (SANS) score more than 20
6.Right-handed
7.Educated upto class VIII or above
8.Patients giving written informed consent. 
 
ExclusionCriteria 
Details  1.Presence of co-morbid neurological or other psychiatric disorder(s).
2.Patient with co morbid substance dependence, except nicotine and caffeine.
3.Having any metallic implants/parts in body
4.Subjects who have received ECT in past 6 months.
5.Colour blind 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in scores on negative and cognitive symptoms after application of HDtDCS.  1. At baseline
2. At the end of 2 weeks
3. At the end of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in fMRI activation of Pre Frontal Cortex using cognitive task and change in resting state functional connectivity at baseline and after application of HDtDCS.  1. At baseline
2. At the end of 2 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/07/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhawnayadav1712@gmail.com].

  6. For how long will this data be available start date provided 12-07-2021 and end date provided 12-07-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Schizophrenia is a chronic debilitating condition where the negative and cognitive symptoms cause functional impairment even after positive symptoms resolve. High definition transcranial direct current stimulation is a non invasive and cost effective neuomodulatory technique with promising results for negative and chronic symptoms of schizophrenia. HDtDCS is a technically enhanced version of tDCS giving a more focal stimulation and has a better predictive stimulation output which will be assessed on clinical rating scales and fMRI.  
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