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CTRI Number  CTRI/2025/10/096533 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Transcranial Direct current stimulation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Transcranial Direct Current stimulation(tDCS) in Obsessive Compulsive Disorder (OCD):A Randomised Controlled Trial 
Scientific Title of Study   Active tDCS Versus Sham tDCS as Adjunctive treatment for OCD(Obsessive Compulsive Disorder):A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maj Dr Sanchit Thakral 
Designation  Resident 
Affiliation  Armed Forces Medical College, Pune 
Address  Department of Psychiatry, Armed Forces Medical College, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9673116218  
Fax    
Email  sanchitthakral@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Lt Col Dr Surender Sharma 
Designation  Associate Professor, Psychiatry 
Affiliation  CHSC, Pune 
Address  Department of Psychiatry, Command Hospital Southern Command, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  8876388436  
Fax    
Email  sursharma_79@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Maj Dr Sanchit Thakral 
Designation  Resident 
Affiliation  Armed Forces Medical College, Pune 
Address  Department of Psychiatry, Armed Forces Medical College, Wanowrie, Pune


MAHARASHTRA
411040
India 
Phone  9673116218  
Fax    
Email  sanchitthakral@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital, Southern Command, Wanowrie, Pune, Pin - 411040 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Dept of Psychiatry, Armed Forces Medical College, Wanowrie, Pune - 411040 
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 
MAJ Dr Sanchit Thakral  Command Hospital Southern Command, Pune  Psychiatr OPD, B5 block, Ground floor
Pune
MAHARASHTRA 
9673116218

sanchitthakral@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee, AFMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sham Transcranial direct current stimulation  Option is provided in equipment to asdminister Sham tDCS where current is gradually tapered and is minimal 
Intervention  Transcranial Direct Current Stimulation  Montage- Anodal stimulation over Lt Deltoid (in an extracephalic position) and Cathodal stimulation over Supplementary Motor Area (SMA) using EEG 10-20 system placing electrode 1.5cm anteriorly to the measured location of Cz. The Intensity will be 2 mA, once daily for 10 sessions over 2 weeks each for duration of 20 minutes? Duration - 01 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Diagnosed with Obsessive Compulsive Disorder (OCD) using any internationally acceptable Diagnostic Criteria
2. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score more than or equal to 16
3. Who are on treatment for at least 12 weeks  
 
ExclusionCriteria 
Details  1.Comorbid Severe Medical and Psychiatric illness which precludes the use of tDCS
2.Scalp injury/skin lesions
3.Implanted medical devices
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in YBOCS scores from baseline  06 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse effects and tolerability  06 weeks 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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   Phase 3 
Date of First Enrollment (India)   01/12/2025 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This is a prospective, double-blind, randomized controlled trial evaluating the efficacy and safety of active transcranial direct current stimulation (tDCS) as an adjunctive treatment compared to sham tDCS in adults aged 18 to 60 years with treatment-resistant obsessive-compulsive disorder (OCD). Participants must have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score more than or equal to 16 and be on stable standard care (SSRIs at therapeutic doses for more than or equal to 12 weeks, with or without CBT). The study aims to recruit 124 participants (62 per group) from the Department of Psychiatry at a tertiary care hospital in Western Maharashtra, India. Intervention involves 10 daily sessions over 2 weeks: active tDCS delivers 2 mA for 20 minutes with anodal placement over the left deltoid (extracephalic) and cathodal over the supplementary motor area (SMA); sham tDCS mimics the setup without active current. Primary outcome is the change in Y-BOCS scores from baseline to 6 weeks post-intervention, with secondary outcomes including adverse effects and tolerability. Follow-up assessments occur at 2 and 6 weeks. The trial duration is 18 months, with statistical analysis using paired t-tests for within-group changes and independent t-tests/Mann-Whitney U for between-group comparisons (p less than 0.05 significant). This study addresses gaps in non-invasive neuromodulation for OCD, building on prior evidence of tDCS’s potential to enhance cortical excitability and reduce symptoms.

 
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