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CTRI Number  CTRI/2023/08/056759 [Registered on: 22/08/2023] Trial Registered Prospectively
Last Modified On: 10/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect Of Adjuvant Intermittent Theta Burst Stimulation For Cognitive Deficits In Schizophrenia 
Scientific Title of Study   Effect of Adjuvant Intermittent Theta Burst Stimulation For Cognitive Deficits In Schizophrenia:An ERP Based Sham Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amy Ida Singh 
Designation  Junior resident  
Affiliation  Central Institute of Psychiatry 
Address  Central Institute Of Psychiatry Ranchi

Ranchi
JHARKHAND
834006
India 
Phone  7903563062  
Fax    
Email  amyida1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aniruddha Mukherjee 
Designation  Associate Professor 
Affiliation  Central Institute Of Psychiatry 
Address  Central Institute Of Psychiatry Ranchi

Ranchi
JHARKHAND
834006
India 
Phone  9474413598  
Fax    
Email  dr_aniruddha@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aniruddha Mukherjee 
Designation  Associate Professor 
Affiliation  Central Institute of Psychiatry 
Address  Central Institute Of Psychiatry Ranchi

Ranchi
JHARKHAND
834006
India 
Phone  09474413598  
Fax    
Email  dr_aniruddha@hotmail.com  
 
Source of Monetary or Material Support  
Central Institute Of Psychiatry, Kanke 
 
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 
Dr Amy Ida Singh  Central Institute Of Psychiatry  KS Mani CCN Lab,Psychiatry Department,Central Institute Of Psychiatry
Ranchi
JHARKHAND 
7903563062

amyida1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Comittee,Central Institute Of Psychiatry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  iTBS,Sham  Sham will be delivered by figure of 8 coil which will be tilted  
Intervention  Theta Burst Stimulation, Active   Double angled cone coil will be placed exact location will be determined by stereotactic neuronavigation ITBS will be delivered to left dmPFC for one session twice a day, 5 days a week for 2 weeks. Using following parameters 600 magnetic pulses delivering in 20 trains with 8 second train interval.  
 
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 -11th edition

2.Minimum 2 years duration of illness and on stable dose of antipsychotics

3.Patients will be screened for cognitive deficit with Montreal Cognitive Assesement Test (MOCA).Cut off score <25

4.Right handed  
 
ExclusionCriteria 
Details  1.Presence of co-morbid neurological disorder

2.Diagnosed intellectual disability

3.Past history of seizure episode

4.Past history of head injury

5.Patients who have received electroconvulsive therapy in last 6 months  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of theta burst stimulation for cognitive deficits and reduction in scores of Montreal Cognitive Assessment Test (MoCA), Digit Symbol Substitution Test (DSST)

 
Effect of theta burst stimulation for cognitive deficits and reduction in scores of Montreal Cognitive Assessment Test (MoCA), Digit Symbol Substitution Test (DSST)

 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of amplitude & latency of P300 component of ERP between active & sham   Comparison of amplitude & latency of P300 component of ERP between active & sham  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   N/A 
Date of First Enrollment (India)   31/08/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Cognitive impairments have long been accepted as core features of schizophrenia that contribute significantly to disability and are generally treatment refractory. Numerous neuropsychological studies demonstrate a broad range of measurable cognitive deficits in Schizophrenia including impairments in attention, working memory (WM), episodic memory, processing speed and executive functions. Despite the enormous importance of cognitive symptoms, there are still no satisfying treatment options in clinical practice. Noninvasive brain stimulation (NIBS) techniques have been proposed as new treatment options for cognitive deficits. The term NIBS summarizes various techniques, including repetitive transcranial magnetic stimulation (rTMS) and its variants. Hence, attempts have been taken to design specific strategies that improve the cognitive deficits. Most of the studies of cognition has been done on dLPFC for cognition. At present, repetitive intermittent theta burst stimulation (iTBS) is a more novel form of rTMS. iTBS is a new form of NIBS, that is characterized by the delivery of 600 pulses within 3 minutes. It produces an increase in motor cortex excitability in a short time, and its excitatory effect may be superior to that of rTMS. Stimulating the dmPFC may increase the integration of information that would otherwise be processed in parallel to those important for self relevant processes. This embedding of information pertaining to the other could potentially explain how humans are able to represent the perspective of others and attribute observable behaviour to unobservable mental attributes. Based on an extensive review, Van Overwalle (2011) concluded that the mPFC is preferentially engaged in social cognition. Studies on rTMS on dmPFC for cognitive symptoms in schizophrenia are lacking. There is however one study been done on dmPFC stimulation on social cognition (Razafimandimby, A et al.,2016). Hence in this study other domains of cognitive deficits would be looked for the effects of iTBS.
 
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