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CTRI Number  CTRI/2023/03/050546 [Registered on: 10/03/2023] Trial Registered Prospectively
Last Modified On: 04/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Use of brain stimulation for treatment of Depression  
Scientific Title of Study   A randomized controlled trial of the effectiveness of Transcranial Direct Current Stimulation (tDCS) for Treatment of Major Depression 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Verma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 4096, 4th Floor, Teaching Block
AIIMS, Ansari Nagar
South
DELHI
110029
India 
Phone  09868005491  
Fax    
Email  rohit.aiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rohit Verma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 4096, 4th Floor, Teaching Block
AIIMS, Ansari Nagar

DELHI
110029
India 
Phone  09868005491  
Fax    
Email  rohit.aiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rohit Verma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 4096, 4th Floor, Teaching Block
AIIMS, Ansari Nagar

DELHI
110029
India 
Phone  09868005491  
Fax    
Email  rohit.aiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi  
Address  Ansari Nagar New Delhi 
Type of Sponsor  Government medical college 
 
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 Rohit Verma  All India Institute of Medical Sciences New Delhi  Room No. 4096, 4th Floor, Teaching Block Department of Psychiatry, AIIMS, Ansari Nagar New Delhi
South
DELHI 
09868005491

rohit.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active Transcranial Direct Current Stimulation (tDCS)  The participants will receive stimulation current at 2mA for 20 min with ramp up of 30 sec and ramp down of 30 sec in a single session. Two sessions per day will be given to the participants. Twenty sessions will be given to a single participant. The anode will be positioned at F3 and cathodal returns will be placed in a ring around the anode (FC1, AF3, F7, FC5) utilizing the International 10-20 EEG system. 
Comparator Agent  Sham Transcranial Direct Current Stimulation (tDCS)  The sham group participants will be receiving the similar set up as the active group participants {viz. anode will be positioned at F3 and cathodal returns will be placed in a ring around the anode (FC1, AF3, F7, FC5)} with the only change that the tDCS system will operate in sham mode delivering no current except during the ramp up and down phases of 30 sec each so that the participant remain blind to the stimulation delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Between age 18-55 years
2. Either gender
3. Right-handed individuals
4. Patients fulfilling the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM 5) criteria for the diagnosis of MDD
5. Ability to read Hindi or English language
6. Willing to give informed consent
7. Medication naïve or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen {including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic (TCAs)} with no change in treatment 4-weeks prior to tDCS intervention
8. HAMD score ≥ 24 (severe depression)(Chistyakov et al., 2010; Goodman et al., 2006) 
 
ExclusionCriteria 
Details  1. Chronic medical or neurological illness (previously diagnosed)
2. Lifetime substance use disorder (excluding tobacco or caffeine) (as per DSM-5)
3. Suffering from or any psychiatric illness other than MDD
4. Not cooperative for testing
5. Past history of significant head injury
6. Known case of intellectual disability
7. Known or suspected pregnancy or currently lactating
8. Head metal implants
9. Subjects with significant suicidal risk upon clinical assessment
10. Any history of seizure
11. Previous history of receiving any brain surgical procedures
12. Implanted metal in their body
13. Electrical or magnetic stimulation on brain in the previous three months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Inter-group differences in change in scale scores (HAMD-17, MADRS and CGI).   At baseline before beginning tDCS session and then after 10 and 20 sessions as well as after 4 weeks of last tDCS session 
 
Secondary Outcome  
Outcome  TimePoints 
Change in parameters obtained in EEG, fNIRS and MRI for correlation to symptom improvement   At baseline before beginning tDCS session and then after 20 sessions and after 24 weeks of last tDCS session 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/04/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Study not yet done or published  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Major depressive disorder (MDD) is a deliberating mental disorder with a high prevalence, and it produces heavy burden and suicide. It is one of the most common psychiatric disorders, but pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted and very serious side effects. Therefore, in addition to antidepressants treating MDD, non-pharmacological interventions have been proposed to treat MDD.

Personalized interventions for people suffering from psychiatric conditions at all stages of illness have seen an evolution in the past few years, from genomic-based subtyping and imaging-based subtyping for the optimization of first-line treatment selection to new methods for individualized image-guided targeting in patients via invasive brain stimulation or non-invasive brain stimulation. Recent literature provides exciting new proof-of-concept strategies for the correction of patient-specific dysfunctions in emotional–cognitive brain circuits for depression by non-invasive neuromodulation strategies like transcranial direct current stimulation (tDCS). Transcranial Direct Current stimulation (tDCS) has been shown to be an effective treatment for depression that can be made portable and used safely, in the privacy of people homes. It could act as the first line of defense treatment for depression. In this study, we seek further validation on the efficacy of tDCS for depression.

This proof-of-concept study intends to recruit 20 individuals suffering from MDD fulfilling the inclusion and exclusion criterion randomly dividing them to receive either active or sham tDCS. 10 patients would be recruited for active tDCS arm and 10 will be included in sham tDCS arm. The outcome parameters would be standard questionnaire-based evaluation method for depression - Montgomery and Asberg Depression Rating Scale (MADRS), Hamilton Depression Rating Scale (HDRS-17) and Clinical Global Impressions (CGI) scale. In addition, electroencephalography (EEG) and functional near infra-red spectroscopy (fNIRS) and Magnetic resonance imaging (MRI) based markers will also be evaluated to analyze if there could be any putative quantitative biomarker for treatment related progress in depression.  Depression questionnaires and cognitive batteries will be performed before the 1st session, after the 10th session and after the 20th session of tDCS as well as 4 weeks after the last tDCS session. Sessions will be conducted twice daily over 10 working days.  Stimulation will begin for 20 min in a single session, two sessions in a day separated by an inter-session interval of at least 3 hours. Participants in active group will receive stimulation during the entire 20 min session while those in sham group will receive stimulation only during the ramp up and ramp down period of about 30 sec so that the participant remain blind to the stimulation delivery. The brain imaging (fNIRS, qEEG & MRI) will be done at baseline before beginning the first tDCS session, repeated after completion of last tDCS session and after 24 weeks (about 6 months) of last tDCS session. Pre- and post-stimulation session EEG will be recorded at resting state daily, and for select event related potential (ERP) before the 1st session, and after the 20th session of tDCS. Analysis will be done using SPSS with p value significant at 0.05.

 
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