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CTRI Number  CTRI/2024/03/063716 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A study to see effect of Repetitive Transcranial Magnetic Stimulation (rTMS) in improving response in drug resistant OCD patients 
Scientific Title of Study   A Study to Observe the Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) as an Augmentation Therapy in Pharmaco-resistant OCD 
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 Suresh Chand Gocher 
Designation  Professor and Head of Department of Psychiatry  
Affiliation  RNT Medical College and MB Hospital  
Address  Dept of Psychiatry, RNT Medical College and MB Government Hospital, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9468569813  
Fax    
Email  sureshgocher1981@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Chand Gocher 
Designation  Professor and Head of Department of Psychiatry  
Affiliation  RNT Medical College and MB Hospital  
Address  Dept of Psychiatry, RNT Medical College and MB Government Hospital, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9468569813  
Fax    
Email  sureshgocher1981@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rohit Yadav 
Designation  PG RESIDENT  
Affiliation  RNT Medical College and MB Hospital  
Address  Dept of Psychiatry, RNT Medical College and MB Government Hospital, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7988188614  
Fax    
Email  rohitgothwal196@gmail.com  
 
Source of Monetary or Material Support  
Dept of Psychiatry, RNT Medical College and MB GOVERNMENT HOSPITAL, Udaipur  
 
Primary Sponsor  
Name  Dept of Psychiatry RNT Medical College and MB GOVERNMENT HOSPITAL 
Address  Udaipur , Rajasthan  
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 Suresh Chand Gocher  Maharana Bhupal Government Hospital and RNT Medical College  2nd floor,Department of Psychiatry
Udaipur
RAJASTHAN 		 9468569813

sureshgocher1981@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RNT Medical College and Controller And Attached Hospitals Udaipur   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  N/A  N/A 
Intervention  Repetitive Transcranial Magnetic Stimulation (rTMS)  Repetitive Transcranial Magnetic Stimulation (rTMS) will be applied for 6weeks to participants taken for study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Response failure to previous or current use of medication or psychotherapy ( response failure was defined as scores more than 16 at Y BOCS despite atleast two SSRI trials of adequate dose and duration)
2. Stable medication regimen 8- 10 weeks before the intervention and unchanged during the treatment (4-6weeks) 
 
ExclusionCriteria 
Details  1. Previous treatment with electroconvulsive therapy, and presence or history of psychosis, substance abuse, suicide attempt and or active suicide ideation, neurological disorder, epilepsy, seizures, and head injury or loss of consciousness
2. According to the safety criteria for rTMS, patients with implanted devices, metal bodies, cardiac arrhythmia, unstable medical conditions, or pregnancy, were also excluded.
3. Patients diagnosed with any other comorbid psychiatric illness except depression and anxiety
4. Patients diagnosed with any other chronic physical illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe the Effect of repetitive transcranial magnetic stimulation in YBOCS score in patients of pharmaco-resistant OCD  After 25th session of rTMS  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Y BOCS , HAM-A and HAM-D scores  After 10th , 15th and 20th session of rTMS 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   18/03/2024 
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 Applicable 
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 - NO
Brief Summary   OCD is a frequent and disabling psychiatric disorder with a lifetime prevalence of 1-3%. Approximately 40-60% of  OCD patients remain treatment refractory to current first line therapies. Repetitive transcranial magnetic stimulation is a non invasive brain stimulation technique proposed as a promising treatment via its neuroplastic effects. This study aims to observe the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as an augmenting treatment method in treatment refractory patients.Kindly consider for CTRI registration. 
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