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CTRI Number  CTRI/2018/04/013121 [Registered on: 09/04/2018] Trial Registered Prospectively
Last Modified On: 29/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Electroconvulsive Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of changing electrical parameters of electroconvulsive therapy (ECT) on outcome and its side effects in people with schizophrenia 
Scientific Title of Study   Comparison of cognitive adverse effects, seizure threshold and efficacy of 2 pulse frequencies (50pps and 125pps) during brief pulse ECT in schizophrenia patients- A double blind randomised controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti Sinha 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences, (NIMHANS) 
Address  Department of Psychiatry, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9243328988  
Fax    
Email  drpreetisinha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Preeti Sinha 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences, (NIMHANS) 
Address  Department of Psychiatry, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore


KARNATAKA
560029
India 
Phone  9243328988  
Fax    
Email  drpreetisinha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Preeti Sinha 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences, (NIMHANS) 
Address  Department of Psychiatry, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore


KARNATAKA
560029
India 
Phone  9243328988  
Fax    
Email  drpreetisinha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore, Karnataka-560029 
 
Primary Sponsor  
Name  Dr Preeti Sinha 
Address  Department of Psychiatry, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore, Karnataka-560029 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Jagadisha Thirthalli  Department of Psychiatry, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore, Karnataka-560029 
Naveen Kumar C  Department of Psychiatry, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore, Karnataka-560029 
Shyam Sundar A  Department of Psychiatry, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore, Karnataka-560029 
Sudhir V  Department of Neuroanaesthesia, National Institute of Mental Health And Neurosciences (NIMHANS), Hosur Road, Bangalore, Karnataka-560029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jagadisha Thirthalli  National Institute of Mental Health and Neurosciences  ECT Suite, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore-560029
Bangalore
KARNATAKA 
9845261731

jagatth@yahoo.com 
Preeti Sinha  National Institute of Mental Health and Neurosciences  Psychiatry Open General Ward, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore-560029
Bangalore
KARNATAKA 
9243328988

drpreetisinha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
NIMHANS Institue Ethics Committee, Behavioural Science Division  Approved 
NIMHANS Institue Ethics Committee, Behavioural Science Division  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Not Applicable 
Intervention  Pulse frequency of 125 pulses per second in ECT  Bifrontal ECT with electric current of Pulse frequency of 125 pulses per second Pulse width 1.5 second, Amplitude of 800 mAmpere 
Intervention  Pulse frequency of 50 pulses per second in ECT  Bifrontal ECT with electric current of Pulse frequency of 50 pulses per second Pulse width 1.5 second, Amplitude of 800 mAmpere 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Diagnosed with Schizophrenia according to DSM-5
2. Referred to receive Bifrontal ECT
3. Able to read and write in Kannada or English or Hindi.
4. Provides consent for study 
 
ExclusionCriteria 
Details  1. ECT within last 3months
2. Mental retardation
3. Comorbid seizure disorders and organic brain disorders
4. Patients with neurological illness which would effect the cognitive functions and psychopathology will be excluded from the study.
5. Patients with a diagnosis of substance use disorder (except nicotine use disorder) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Verbal Memory (delayed Recall)
Autobiographical Memory 
1 or 2 days before 1st ECT
Within 2 days after 6th or last ECT, whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
Over all clinical status through standardised scales-
Nurses Observation Scale for Inpatient Evaluation (NOSIE)
Brief Psychiatric Rating Scale (BPRS)
Clinical Global impression-Severity (CGI-S) 
Before 1st ECT
After 6th or Last ECT, whichever is earlier 
Seizure threshold  During 1st ECT 
Other cognitive outcomes-
Verbal Fluency, Verbal memory (Immediate Recall), Visual memory, Working memory 
Before 1st ECT
After 6th or Last ECT, whichever is earlier 
Specific clinical outcomes-
Bush Francis Catatonia Rating Scale
Calgary Depression Scale for Schizophrenia 
Before 1st ECT
After 6th or Last ECT, whichever is earlier 
Iictal and post ictal fractal dimension of EEG recordings  During 2nd ECT
During 6th ECT 
Percentage increase in (RPP) Heart Rate Systolic Blood Pressure Product during ECT induced seizure   During 2nd ECT
During 6th ECT 
Duration of pupillary non-response during ECT induced seizure   During 2nd ECT
During 6th ECT 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/04/2018 
Date of Study Completion (India) 30/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/10/2019 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Electroconvulsive therapy (ECT) is one of the earliest treatments available for the treatment in psychiatric disorders and has a distinct position in psychiatric treatment guidelines. In last many years there have been a lot of research done by modifying various electrical parameters  of ECT to address its cognitive adverse effects without compromising efficacy. One of them is the alteration of pulse frequency of electric current administered in ECT. There have been only 2 RCTs and few cases series done to examine effect of ECT pulse frequency. The results of them indicated positive effect on efficacy, reduction in seizure threshold with lower pulse frequency, without affecting the cardiovascular response. The examination of cognitive effects, detailed morphology of EEG recordings and other parameters of adequate seizures have not been conducted. Further, these studies were done in patients with depression, when schizophrenia is an equally considered indication of ECT in Asian countries. Hence, this study is planned to examine the effects of reduction in pulse frequency (50 pps from 125pss) of bifrontal ECT in patients with schizophrenia on various cognitive and clinical outcomes, seizure threshold and physiological parameters including EEG morphology, which all indicate the adequacy of seizures. This was carried out as the double blind randomized controlled trial through 2 MD Psychiatry thesis dissertations in National Institute of Mental Health and Neurosciences, Bangalore from September 2018 to October 2019 after taking approval from Institute Ethical Committee.

We could recruit 46 patients with schizophrenia including both groups. The patients in 50pps and 125pps groups were comparable in both socio-demographic and baseline clinical variables. In terms of clinical efficacy for schizophrenia, both the groups showed similar improvement in psychopathology, catatonic behaviour, and general ward behaviour as well as global assessment. There was neither difference in 2nd nor 6th ECT session EEG and CVS parameters between the 2 groups. In each group, all these parameters also didn’t differ between 2nd and 6th ECT sessions recordings. Seizure threshold for ECT also were similar in 50pps and 125pps groups.

On comparison of performance on cognitive variables assessed before 1st ECT session and Post 6th ECT session (as calculated by Wilcoxon signed-rank test), there was statistically significant decline in autobiographical memory (p=0.048), word short delayed recall ( p=0.035), word recognition (p=0.011), visual recognition (p=0.027) and phonemic fluency (p=0.007) in 125pps group. In contrast, 50pps group performed similarly on these cognitive variables in both assessments. However, significant improvement was noted in visual delayed recall (p=0.011) in post 6th ECT session assessment compared to 1st ECT session in 50pps group. This difference was absent in 125pps group. None of these pre-post differences between 50pps and 125pps groups was evident in time*group RMANOVA. The clinical status of patients posted for ECT precluded some of the patients from co- operating for pre ECT cognitive assessments, which reduced sample size further during RMANOVA. There is a need to conduct similar study with larger sample size in order to confirm findings of this study and also to see the effects in sub-groups such as elderly.

 
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