CTRI

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CTRI Number

CTRI/2024/10/075148 [Registered on: 11/10/2024] Trial Registered Prospectively

Last Modified On:

16/07/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Medical Device

Study Design

Other

Public Title of Study

We compared how well brain stimulation helps OCD patients when targeting two different brain areas supplementary motor area and left dorsolateral prefronatal cortex

Scientific Title of Study

A naturalistic, quasi- experimental study comparing the effectiveness of accelerated TBS targeting left SMA and left DLPFC among patients with obsessive compulsive disorder

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Priyanshi chaudhary
Designation	junior resident
Affiliation	King Georges Medical University
Address	Department of Psychiatry King Georges Medical University Lucknow Lucknow UTTAR PRADESH 226003 India
Phone	06307975875
Fax
Email	priyaansh9896@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sujit Kumar Kar
Designation	Additional Professor
Affiliation	King Georges Medical University
Address	Department of Psychiatry King Georges Medical University Lucknow UTTAR PRADESH 226003 India
Phone	9956273747
Fax
Email	Drsujita@gmail.com

Details of Contact Person
Public Query

Name	Priyanshi chaudhary
Designation	junior resident
Affiliation	King Georges Medical University
Address	Department of Psychiatry King Georges Medical University Lucknow UTTAR PRADESH 226003 India
Phone	6307975875
Fax
Email	Priyaansh9896@gmail.com

Source of Monetary or Material Support

King Georges Medical University Lucknow uttar pradesh India 226003

Primary Sponsor

Name	King Georges Medical University
Address	Department of Psychiatry King Georges Medical University Lucknow UP India 226003
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 priyanshi chaudhary	king George medical university	Department of Psychiatry, TMS room Lucknow UTTAR PRADESH	6307975875 priyaansh9896@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
King George Medical University	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F42\|\|Obsessive-compulsive disorder,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Nil	Nil
Intervention	Repeatitive trans cranial magnetic stimulation in ocd opatients	to study the efficacy of rTMS in OCD patients targeting different areas Protocol 1 at left DLPFC; aiTBS with an amplitude of 100%, frequency, 20 trains, pulses in a train 300, and total pulses 600 will be delivered in a single session. Protocol 2 at left SMA: acTBS with an amplitude of 100%, a frequency of 5Hz, 2 trains, pulses in a train 300 and a total of pulses 600 will be delivered in a single session

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1 Patients with a diagnosis of OCD as per DSM 5 criteria 2 Age between 18 and 60 years 3 OCD with severity moderate or higher YBOCS MORE THAN 15 4 Patient on a stable dose of SSRI medication Fluoxetine equivalent dose of 40 to 80 mg per day for at least 1 month and a maximum duration of 3 months 5 Participant agreeing to give written informed consent

ExclusionCriteria

Details

1 Other comorbid psychiatric illnesses (except tobacco use disorder and mild to moderate depression)
2 Any medical morbidity that significantly interferes with psychiatric assessmenent.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To compare the effectiveness of acTBS protocol targeting left supplementary motor area and aiTBS at left dorsolateral prefrontal cortex in reducing the YBOCS score among patients with Obsessive Compulsive Disorder	Assessment will be done at baseline, week 1, week 2, and week 4 of the study.

Secondary Outcome

Outcome

TimePoints

Secondary objective To determine the change in resting motor threshold (RMT) among patients with Obsessive Compulsive Disorder with acTBS protocol targeting left supplementary motor area versus aiTBS at left dorsolateral prefrontal cortex
To determine the change in depressive symptoms and subjective well-being among patients with Obsessive Compulsive Disorder with acTBS protocol targeting left supplementary motor area versus aiTBS at left dorsolateral prefrontal cortex

baseline, after 10 sessions, after 20 sessions, and 4 weeks after 20 sessions

Target Sample Size

Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56"

Phase of Trial

N/A

Date of First Enrollment (India)

24/10/2024

Date of Study Completion (India)

16/02/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

16/02/2026

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

Patients attending Adult Psychiatry OPD, Department of Psychiatry, KGMU, on all OPD days clinically diagnosed with OCD as per DSM 5 and on a stable dose of medication as per selection criteria, the patients will continue to receive SSRI (Equivalent dose of Tab Fluoxetine 40 to 80 mg/day) medication during the treatment. Rescue medication may be used in the case of anxiety and insomnia including Clonazepam (up to 1mg/day) and Zolpidem (up to 10mg/day) respectively. Now, planned to receive either aiTBS protocol targeting DLPFC or acTBS protocol targeting SMA.

The patient will be assessed for inclusion in the study. A written informed consent will be taken from the patients prior to inclusion in the study. Following enrollment, the socio-demographic and clinical details of the patient will be recorded using Semi-Structured Proforma. Baseline clinical variables will be measured using scales, i.e. TMS screening checklist for screening patients suitable for TMS, Y-BOCS (yale brown obsessive compulsive Scale) to assess the severity of OCD, Patient Health Questionnaire-9(PHQ-9) to assess the severity of comorbid depression, Generalized Anxiety Disorder Screener(GAD-7) to assess the severity of comorbid anxiety, WHO5 well-being index for the psychological wellbeing of the patient. Patients fulfilling the selection criteria will be recruited in the study if required may be hospitalized for rTMS. A total of 20 sessions of TBS, 2 sessions per/day at an interval of 15 minutes will be delivered over a period of two weeks following treatment protocol as described below.

(Protocol 1 at left DLPFC; aiTBS with an amplitude of 100%, frequency, 20 trains, pulses in a train 300, and total pulses 600 will be delivered in a single session.

Protocol 2 at left SMA: acTBS with an amplitude of 100%, a frequency of 5Hz, 2 trains, pulses in a train 300 and a total of pulses 600 will be delivered in a single session.)

Assessment will be done at baseline, week 1, week 2, and week 4 of the study. In case the patient develops any minor adverse effects due to rTMS, it will be managed conservatively. If any serious adverse effect develops, the patient will be dropped from the study and appropriate medical care will be provided.