| 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
|
|
|
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
|
|
|
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
|
|
|
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. |