| CTRI Number |
CTRI/2025/08/092300 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| 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
|
Does magnetic stimulation of the brain improve the symptoms of obsessive-compulsive disorder? |
|
Scientific Title of Study
|
Accelerated deep intermittent theta-burst stimulation of medial prefrontal/anterior
cingulate cortex for medication-resistant obsessive-compulsive disorder: A multi-site
randomised sham-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOCRDF/2025/01902 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyam Sundar Arumugham |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatry
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9008600112 |
| Fax |
|
| Email |
a.shyamsundar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shyam Sundar Arumugham |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatry
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9008600112 |
| Fax |
|
| Email |
a.shyamsundar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyam Sundar Arumugham |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatry
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9008600112 |
| Fax |
|
| Email |
a.shyamsundar@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIMHANS Obsessive Compulsive and related fund (NOCRDF)
Department of Psychiatry
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Bangalore Karnataka 560029 India |
|
|
Primary Sponsor
|
| Name |
Shyam Sundar Arumugham |
| Address |
Department of Psychiatry
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Hosur Road
Bengaluru 560029
Karnataka
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishant Goyal |
Central Institute of Psychiatry |
Department of Psychiatry
Central Institute of Psychiatry
Patratoli
Kanke
Jharkhand
834006
Ranchi
JHARKHAND |
06512451115
psynishant@gmail.com |
| Dr Shyam Sundar Arumugham |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
Department of Psychiatry National Institute of Mental Health and Neuro Sciences
Hosur Road
Bengaluru 560029
Karnataka
India
Bangalore
KARNATAKA |
9008600112
a.shyamsundar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Central Institute of Psychiatry |
Approved |
| NIMHANS IEC (Behavioural Sciences Division |
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 |
Intermittent Theta Burst Stimulation (iTBS) |
Accelerated iTBS targeting medial prefrontal cortex and anterior cingulate cortex, administered using Brainsway Model 104 stimulator and H7 coil (Brainsway, Jerusalem, Israel). Stimulation is delivered at 100 percent resting motor threshold through a ramp-up process. Each session includes 1980 pulses in 66 trains, with each train consisting of 10 bursts of 3 biphasic pulses delivered at 50 Hertz. At total of 30 sessions will be provided over 5 days. |
| Comparator Agent |
Sham Stimulation |
Sham iTBS delivered using the same Brainsway H7 helmet system, with identical parameters but without magnetic field induction. Sham stimulation uses low-intensity electric currents and sound mimicking the active condition, without brain penetration. At total of 30 sessions will be provided over 5 days. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Primary diagnosis of obsessive-compulsive disorder as per DSM-5 criteria, confirmed using the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND).
Inadequate response to at least one adequate trial of serotonin reuptake inhibitor.
On stable psychotropic medications for a minimum of 8 weeks.
Not undergoing cognitive behavioural therapy at the time of recruitment.
Yale-Brown Obsessive Compulsive Scale score of 16 or higher.
Clinical Global Impressions Severity score of 4 or higher. |
|
| ExclusionCriteria |
| Details |
Presence of comorbid psychotic disorders, bipolar disorder, or active substance use disorder (except nicotine or caffeine dependence).
Active suicidality.
History suggesting intellectual disability.
Contraindications to repetitive transcranial magnetic stimulation or magnetic resonance imaging.
Pregnancy.
Presence of unstable medical conditions or severe neurological disorders requiring immediate medical attention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) severity score from baseline |
1 week after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in resting-state functional connectivity in anterior cingulate and prefrontal regions,
Change in ACC functional connectivity, MRS glutamate levels and amplitude of ERN |
1 week after the end of treatment |
| HAM-A and HAM-D scores |
1 week after end of treatment |
| Change in YBOCS, HAM-A and HAM-D score at the end of phase 2 and Phase 3 |
6 weeks and 12-18 weeks after the end of treatment |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="3"
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 - NO
|
|
Brief Summary
|
This multi-site, randomised, double-blind, sham-controlled trial aims to evaluate the clinical efficacy, safety, and neurobiological effects of accelerated deep intermittent theta-burst stimulation (iTBS) targeting the medial prefrontal and anterior cingulate cortices in individuals with medication-resistant OCD. The study will enrol 72 patients with OCD and 36 healthy volunteers across two Indian centres: NIMHANS, Bengaluru and CIP, Ranchi. Patients will be randomised to receive either active or sham iTBS over five consecutive days (six sessions per day; total 30 sessions). The primary outcome is the change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score one week after completion of phase-1 treatment. Secondary outcomes include changes in Clinical Global Impressions Severity (CGI-S), Depression Anxiety Stress Scales (DASS), cognitive task performance, cortical excitability and connectivity (EEG), and resting-state functional connectivity (fMRI). Healthy controls will undergo the same stimulation protocol to characterise normative neurophysiological changes and support identification of biomarkers associated with treatment response. |