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Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder

Study acronym: TMS-OCD-EEG
StatusRecruiting
PhaseNot applicable
Started2026-01-01
View on ClinicalTrials.gov ↗

Amendment history

2026-05-07
Study Status, Sponsor/Collaborators, Study Design, Outcome Measures, Eligibility v1
Phase changed: Phase 4 → not applicable
Primary endpoint(s) modified2 to 1 entries
WasAnalysis of microstate EEG, Yale-Brown Obsessive-Compulsive Scale
NowYale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
Completion moved earlier: 2027-05-01 → 2027-04-01
Start date2026-02-01→2026-01-01
Eligibility criteria-179 characters
[...] ing a Y-BOCS score of ≥20 following the initial evaluation. Receiving maintenance treatment with a therapeutic dose of SSRI for at least 2 months. No change in the current SSRI or other medications within the last 2 months and a commitment to ma [...] ing informed consent and having no contraindications for TMS. Exclusion Criteria: Severe neurological disorders (e.g., brain tumor, progressiveor neurodegenerative diseases). Any condition associated with increased seizure risk (e.g., epilepsy, history of severe head trauma). History of cochlear implants, metal implants in the head an [...]
Secondary endpoints+91 characters
EEG Microstate Analysis Parameters Frontal-Vagal Activity via Heart Rate Deceleration (HRD)
2026-04-26
Original filing
Purpose: This study aims to evaluate the effectiveness of an accelerated intermittent Theta Burst Stimulation (iTBS) protocol-a non-invasive brain stimulation technique-targeted at the dorsomedial prefrontal cortex (dmPFC) and anterior cingulate cortex (ACC) in patients with treatment-resistant Obsessive-Compulsive Disorder (OCD). Additionally, the study seeks to identify electrophysiological biomarkers (such as EEG microstates and heart rate variability) that may predict which patients are most likely to benefit from the treatment. Methodology: The study will include 30 patients aged 18-65 diagnosed with OCD according to DSM-5 criteria who have not responded sufficiently to standard treatments. Participants will undergo an intensive 7-day treatment program consisting of 4 iTBS sessions per day (totaling 28 sessions). Clinical symptoms will be assessed before and after the treatment using standardized scales, including the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A). Resting-state EEG measurements and heart rate data will be recorded during and after the sessions to analyze physiological changes. Goal: The findings are expected to contribute to the development of personalized neuromodulation protocols and help identify predictors of treatment response for OCD patients.
Trial Details
NCT Number NCT07561528
Lead Sponsor Istanbul University - Cerrahpasa
Conditions Obsessive - Compulsive Disorder, Transcranial Magnetic Stimilation, Intermittent Theta Burst Stimulation, EEG
Enrollment 30 participants
Start Date 2026-01-01
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-08