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CTRI Number  CTRI/2025/10/096730 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Magnetic brain stimulation as an additional treatment for children and teenagers with obsessive-compulsive disorder 
Scientific Title of Study   Deep Transcranial Magnetic Stimulation as add-on treatment for Children and Adolescents with Obsessive Compulsive Disorder: An open label study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyadeep Zamindar 
Designation  Senior Resident 
Affiliation  NIMHANS, Bengaluru 
Address  Department of Child and Adolescent Psychiatry, NIMHANS, Hosur Road, Bengaluru, India, 560029

Bangalore
KARNATAKA
560029
India 
Phone  9830991303  
Fax    
Email  zamindard@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harshini Manohar 
Designation  Assistant Professor 
Affiliation  NIMHANS, Bengaluru 
Address  2nd floor, Adolescent psychiatry building, Department of Child and Adolescent Psychiatry, NIMHANS, Hosur Road, Bengaluru, India, 560029

Bangalore
KARNATAKA
560029
India 
Phone  9176402954  
Fax    
Email  harshinimanohar1990@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harshini Manohar 
Designation  Assistant Professor 
Affiliation  NIMHANS, Bengaluru 
Address  2nd floor, Adolescent psychiatry building, Department of Child and Adolescent Psychiatry, NIMHANS, Hosur Road, Bengaluru, India, 560029

Bangalore
KARNATAKA
560029
India 
Phone  9176402954  
Fax    
Email  harshinimanohar1990@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health And Neurosciences, Hosur Road, Bengaluru, India, 560029 
 
Primary Sponsor  
Name  NIMHANS Bengaluru 
Address  NIMHANS, Hosur Road, Bengaluru, India, 560029 
Type of Sponsor  Research institution and hospital 
 
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 Priyadeep Zamindar  NIMHANS Hospital  Department of Child and Adolescent Psychiatry, NIMHANS, Hosur Road, Bengaluru, India, 560029
Bangalore
KARNATAKA 		 9830991303

zamindard@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS ETHICS COMMITTEE  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 
Intervention  Deep Transcranial Magnetic Stimulation  Deep Transcranial Magnetic Stimulation (dTMS) is a non-invasive brain stimulation modality that uses repeated pulses of magnetic stimulation in specific parts of the brain. The current study involves use of the H7 dTMS coils to target the Anterior Cingulate Cortex (ACC) and medial Pre-frontal Cortex (mPFC) using "High Frequency" 20Hz stimulation in standardized protocol for OCD. Each session will take roughly 20 minutes each. Each participant will be given 20 sessions total at one session per day, 6 days a week. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Individuals with primary diagnosis of OCD as per DSM-5, age 7-17 of any gender, with a previous trail of at least 12 weeks of an SSRI or CBT 
 
ExclusionCriteria 
Details  History of seizure, head injury, other neurological conditions that may reduce seizure threshold, raised intra-cranial tension, metal implants in head or face, Severe metal illness such as Schizophrenia or Bipolar Disorder, Acute suicidal Risk, Moderate/Severe/Profound Intellectual Disability 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the severity of obsessive-compulsive symptoms as assessed by CY-BOCS, post intervention

Overall clinical improvement as assessed by CGI, post intervention  		 Baseline, 4 weeks, 1 month post-intervention and 3 months post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in comorbid depression and anxiety symptoms post intervention as assessed by RCADS  T1- Pre-intervention
T2- Post 20 sessions of dTMS 
Maintenance of intervention effects at 1 month (T3) and 3 months (T4) post-intervention as measured by CY-BOCS and CGI scores  T1- Pre-intervention
T2- Post 20 sessions of dTMS
T3- 1 month post-intervention
T4- 3 months post-intervention 
 
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)   18/11/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [harshinimanohar1990@gmail.com].

  6. For how long will this data be available start date provided 21-12-2026 and end date provided 21-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The current study is to be carried out in the National Institute of Mental Health And Neurosciences, Bengaluru. Children and Adolescents with primary diagnosis of OCD and previous failed trial of SSRI/CBT will be recruited for trial of dTMS as an add-on therapy in addition to treatment as usual. It is a single-arm open label trial. Each individual will be screened for inclusion/exclusion criteria, Screening standard questionnaire for TMS safety and comorbidities using DIAMOND-KID. Informed consent from parents and assent from children/adolescents will be taken. 20 sessions of high-frequency deep TMS will be given with one session each day. TMSens_Q, a tool to track adverse effects of TMS will be used to monitor participants and participation will be discontinued in case of any serious adverse effect. OCD severity will be measured using CY-BOCS; Anxiety/depression using RCADS and overall clinical condition using CGI and CGAS scales. Clinical scales will be applied at T1 (Pre-intervention), T2(post-intervention), T3(1 month post-intervention) and T4(3months post-intervention). Linear mixed model will be used to assess the effect of the intervention accounting for within-subject correlations with time as a fixed factor. 
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