| 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
|
|
|
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
|
|
|
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. |