Which Brain Stimulation works better for severe Obsessive Compulsive Disorder? A Randomized Controlled Trial comparing two techniques.

Phase 2/3

Not yet recruiting

• Conditions: Mixed obsessional thoughts and acts,

• Registration Number: CTRI/2025/06/089336
• Lead Sponsor: Dr Manisha Deo

Brief Summary

This study is a randomized, outcome assessor  blinded , parallel group, single center trial comparing the effectiveness of Intermittent Theta Burst Stimulation to standard High Frequency Transcranial Magnetic Stimulation in 56 patients with drug resistant Obsessive Complusive Disorder  that will be conductedin 1 center in India. Theprimary outcome measures will be change in Yale Brown Obsessive Complusive scale, Clinical Global Impression, Dimensional Obsessive Compulsive Scale and Hamilton Anxiety Rating Scale scores at baseline, day 12 , day 33 for control arm, follow up week 4 and week 12. Thesecondary outcomes will be treatment emergent adverse events after every TMS session.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-22
• Study Start: 2025-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1 Age 16 to 60 years 2 Patients meeting diagnostic criteria for OCD according to ICD 11 with YBOCS score of 15 out of 40 3 Patients with OCD meeting criteria of drug resistance defined as a patient showing less than 25 percent reduction in baseline YBOCS score to at least 2 SSRIs at maximum recommended doses for a trial duration of at least 12 weeks 4 Both male and females are included 5 Patient willing to provide written informed consent.

Exclusion Criteria

1 Patients with seizure disorder 2 Patients with metallic implants 3 Patients with hearing impairments 4 Patients with brain injury 5 Patients with migraine or frequent complains of severe headache 6 Patients with stroke or history of cerebrovascular accident 7 Patients with co morbid psychiatric disorder except mild depression assessed by Hamilton Depression score of less than 17 8 History of substance abuse except tobacco or caffeine 9 Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Number of missed sessions for each group and the reason for missed sessions will be assessed.	Baseline, day 12 , day 33 (for control arm only), follow up week 4 and week 12
3. Treatment completion and dropout: In each group, the number of participants completing the study despite missed sessions and the number of participants who dropout will be determined.	Baseline, day 12 , day 33 (for control arm only), follow up week 4 and week 12
1.Severity of OCD will be measured by Yale Brown Obsessive Compulsive Scale ,Clinical Global Impression, Dimensional Obsessive-Compulsive Scale and Hamilton Anxiety Rating Scale scores.	Baseline, day 12 , day 33 (for control arm only), follow up week 4 and week 12

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse events

Trial Locations

Locations (1)

All India Institute of Medical Science, Gorakhpur; 🇮🇳 Gorakhpur, UTTAR PRADESH, India

All India Institute of Medical Science, Gorakhpur

🇮🇳Gorakhpur, UTTAR PRADESH, India

Dr Manisha Deo

Principal investigator

dev.manisha473@gmail.com