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CTRI Number  CTRI/2026/03/105340 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 03/03/2026
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   A Clinical Trial of Accelerated Dual-site Continuous Theta Burst Stimulation for Obsessive-Compulsive Disorder 
Scientific Title of Study   Efficacy and Safety of Accelerated Sequential Dual-site Continuous Theta Burst Stimulation in Obsessive Compulsive Disorder and Neurobiological Correlates of Treatment Response: 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  Godi Sangha Mitra 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of Psychiatry, AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  09492414295  
Fax    
Email  mitratriam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Godi Sangha Mitra 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of Psychiatry, AIIMS Mangalagiri


ANDHRA PRADESH
522503
India 
Phone  09492414295  
Fax    
Email  mitratriam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Godi Sangha Mitra 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of Psychiatry, AIIMS Mangalagiri


ANDHRA PRADESH
522503
India 
Phone  09492414295  
Fax    
Email  mitratriam@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS Mangalagiri 
Address  Dept of Psychiatry, AIIMS Mangalagiri, Guntur, Andhra Pradesh, India, 522503 
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 
Godi Sangha Mitra  AIIMS Mangalagiri  Department of Psychiatry, 2nd floor, Outpatient block, AIIMS Mangalagiri, India, 522503
Guntur
ANDHRA PRADESH 
09492414295

mitratriam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Mangalagiri  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  Accelerated cTBS  Continuous theta burst stimulation (cTBS) over Right dorsolateral prefrontal cortex followed by bilateral SMA at 80% active motor threshold, 1800 pulses per session over 2 minutes, Intersession interval: 50 minutes, 6 sessions per day for 5 consecutive days (30 sessions total) using a figure of 8 coil, Magstim Rapid.  
Comparator Agent  Sham  Sham TMS was carried out with the same coil tilted 90° perpendicular to the skull with pulses delivered at a low intensity (10% resting motor threshold, rMT) to elicit similar skin sensations as real stimulation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age Range between 18 to 60 years.
2.Diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria.
3.Moderate to severe OCD, indicated by a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of more than 20.
4.Inadequate response to at least one adequate trial of a selective serotonin reuptake inhibitor (SSRI) and/or structured Cognitive Behavioral Therapy (CBT)
5.Ability to understand and sign informed consent documents.
 
 
ExclusionCriteria 
Details  1.Current diagnosis of schizophrenia, bipolar disorder, or primary major depressive disorder.
2.Substance use disorder within the past 6 months (excluding caffeine or nicotine).
3.Any major neurological disorder (e.g., epilepsy, Parkinson’s disease, or history of significant head trauma).
4.Any serious or unstable medical condition that might interfere with participation.
5.Currently pregnant or breastfeeding.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The change in the YBOCS score will be the primary outcome, and those with more than 35% decrease in YBOCS score will be defined as treatment responders  Baseline (T0), End of Treatment (T1), 4-week follow-up (T2), 12-week follow-up (T3) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in severity of illness and depression as measured by CGI-S, BDI, and CSSRS, respectively.   Baseline (T0), End of Treatment (T1), 4-week follow-up (T2), 12-week follow-up (T3) 
To understand the neurophysiological Correlates of Treatment response in OCD using FNIRS and EEG
 
Baseline (T0) and 12-week follow-up (T3) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2 
Date of First Enrollment (India)   14/03/2026 
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  

Obsessive-Compulsive Disorder (OCD) is a chronic, relapsing neuropsychiatric disorder characterised by intrusive thoughts (obsessions) and repetitive behaviours (compulsions). It affects 2–3% of the population and significantly impairs personal, occupational, and social functioning. While selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioural therapy (CBT) are first-line treatments, approximately 40% of patients are refractory to these interventions. Despite advancements in pharmacotherapy and psychotherapy, treatment-resistant OCD remains a major clinical challenge. Functional neuroimaging implicates hyperactivity in the cortico-striato thalamo-cortical (CSTC) circuit, particularly the supplementary motor area (SMA), in pathophysiology of OCD. Non-invasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), have demonstrated potential in modulating these circuits through stimulation of neuroanatomical targets implicated in OCD. Deep TMS is FDA-approved for OCD and the most evidence-based TMS approaches target the right dorsolateral prefrontal cortex (DLPFC) and supplementary motor area using inhibitory protocols, with good response in 40–50% of patients.

Theta burst stimulation (TBS), a patterned form of rTMS, can induce neuroplastic changes in a shorter duration and at lower intensities. Continuous TBS (cTBS) offers inhibitory effects and has shown promise when applied to SMA. Recent international studies and systematic review report that accelerated TBS protocols—multiple daily sessions over a short span are safe, well-tolerated, and result in faster clinical improvement. However, there is a critical lack of studies from India evaluating accelerated cTBS in OCD. Additionally, Indian healthcare systems can benefit from shorter-duration interventions to improve accessibility and adherence. Thus, this randomised controlled study will assess the role of sequential accelerated cTBS over Right DLPFC, followed by Bilateral SMA (supplementary motor area), and compare it with sham stimulation, potentially offering a safe and rapid-acting adjunct treatment for OCD.

 
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