| CTRI Number |
CTRI/2019/05/018947 [Registered on: 06/05/2019] Trial Registered Prospectively |
| Last Modified On: |
28/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of high definition transcranial direct current stimulation in negative symptoms of Schizophrenia and changes in proton magnetic resonance spectroscopic findings |
|
Scientific Title of Study
|
Efficacy of high definition transcranial direct current stimulation in negative symptoms of Schizophrenia as measured by proton magnetic resonance spectroscopy - a randomised sham controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharani R |
| Designation |
Junior resident |
| Affiliation |
Central institute of psychiatry |
| Address |
Room no.8, hodgsons ladies hostel, Central institute of psychiatry
Kanke
Ranchi
JHARKHAND
834006
India |
| Phone |
8667413791 |
| Fax |
|
| Email |
dharuridu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Goyal |
| Designation |
Assistant professor |
| Affiliation |
Central institute of psychiatry |
| Address |
fMRI Centre & K S Mani Centre for Cognitive Neurosciences, Central institute of psychiatry
Kanke
Ranchi
JHARKHAND
834006
India |
| Phone |
9431171162 |
| Fax |
|
| Email |
psynishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Goyal |
| Designation |
Assistant professor |
| Affiliation |
Central institute of psychiatry |
| Address |
fMRI Centre & K S Mani Centre for Cognitive Neurosciences, Central institute of psychiatry
Kanke
Ranchi
JHARKHAND
834006
India |
| Phone |
9431171162 |
| Fax |
|
| Email |
psynishant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry kanke ranchi Jharkhand |
|
|
Primary Sponsor
|
| Name |
Central institute of psychiatry |
| Address |
Kanke ranchi 834006 |
| 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 |
| Dharani R |
Central Institute of Psychiatry |
fMRI centre and K S Mani centre for congnitive neurosciences, CIP, kanke
Ranchi
JHARKHAND |
8667413791
dharuridu@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F203||Undifferentiated schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Definition transcranial Direct Current Stimulation Active |
The central active anode electrode will be placed over the left dorsolateral prefrontal cortex which will be surrounded by 4 return (anode) electrodes which will determine the modulation area, which will be 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. The active anode electrode will be placed over f3 (using EEG 10/10 system) and 2mA current applied for 20 minutes. |
| Comparator Agent |
High Definition transcranial Direct Current Stimulation sham |
The anode will be placed over a Point F3 (Left DLPFC) and which will be surrounded by 4 return (anode) electrodes which will determine the modulation area, which will be connected to a four-to-one wire adaptor for the DC stimulator. 1 mA current will be applied for 30 sec giving an initial sensation of HDtDCS while minimizing stimulatory 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. Age between 18- 60 years of either sex
3. The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score of more than 15
4. Scale for Assessment of Negative Symptoms (SANS) score more than 20
5. Calgary Depression Scale for Schizophrenia (CDSS) score less than 7
6. Right handed
7. 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 Electroconvulsive therapy in past 6 months.
|
|
|
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 |
| Primary outcome of the study is change in negative symptoms score as assessed at the end of 2 weeks of HDtDCS treatment with the specially designed score sheet. |
PANSS, SANS, CGI, CDSS WILL BE APPLIED AT THE END OF 2 WEEKS & 6WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes are changes in the levels of GABA, Glutamate, Glutamine, N-Acetyl Aspartate & N-Acetyl Aspartyl Glutamate in Dorsolateral Prefrontal Cortex using Proton MR Spectroscopic imaging and overall severity scores on CGI. |
Proton Magnetic Resonance Spectroscopy will be done before giving HD tDCS and after 2 sessions of HD tDCS and at the end of 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2019 |
| Date of Study Completion (India) |
30/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
Modification(s)
|
journal of ECT |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Negative symptoms are highly relevant in the long course of schizophrenia. Antipsychotic drugs have been only mildly effective in improving negative symptoms. Negative symptoms are consistently related to specific neuroanatomical correlates, especially the prefrontal cortex. Promising results have been obtained in the study of effect of tDCS on negative symptoms. The study aims at assessing the effect of High Definition trancranial Direct Current Stimulation in negative symptoms of schizophrenia as measured by proton magnetic spectroscopic findings of left dorsolateral prefrontal cortex. |