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

Effectiveness of Intermittent Theta Burst Stimulation versus standard High Frequency Transcranial Magnetic Stimulation in drug resistant Obsessive Compulsive Disorder patients : Non-Inferiority Randomised Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089336

Enrollment

Registered

2025-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F422- Mixed obsessional thoughts and acts

Interventions

Intervention1: Intermittent Theta Burst Transcranial Magnetic Stimulation: Intermittent Theta Burst Stimulation involves using Cool DB80 coil to provide magnetic stimulation of 600 pulses per session

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 2. Number of missed sessions for each group and the reason for missed sessions will be assessed. 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.Timepoint: Baseline, day 12 , day 33 (for control arm only), follow up week 4 and week 12	—

Measure

Time frame

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. 2. Number of missed sessions for each group and the reason for missed sessions will be assessed. 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.Timepoint: Baseline, day 12 , day 33 (for control arm only), follow up week 4 and week 12

—

Secondary

Measure	Time frame
Treatment emergent adverse events Timepoint: For control group: Day 1,2,3,4,5,8,9,10,11,12,15,16,17,18,19,22,23,24,25,26,29,30,31,32,33, week 4 (post completion) For intervention group: Day 1,2,3,4,5,8,9,10,11,12 , week 4 (post completion)	—

Countries

India

Contacts

Public ContactDr Manoj Prithviraj

All India Institute of Medical Science, Gorakhpur

manoprithv@gmail.com9854019389

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026