| 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
|
|
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. |