| 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
|
|
|
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
|
|
|
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. |