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

Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy

Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder (NCT07561528) is a Phase 4 interventional studying Obsessive - Compulsive Disorder and Transcranial Magnetic Stimilation, sponsored by Istanbul University - Cerrahpasa. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Being between 18 and 65 years of age. Being diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria. Non-responsiveness to at least one Selective Serotonin Reuptake Inhibitor (SSRI) treatment at an adequate dose and duration. Having 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 maintaining stable doses throughout the study. Providing willing to sign a consent form and having no contraindications for TMS Who Should NOT Join This Trial: Severe neurological disorders (e.g., brain tumor, progressive 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 and neck area, cardiac pacemakers, deep brain stimulation, or vagus nerve stimulation. History of neurosurgical intervention. General contraindications for Transcranial Magnetic Stimulation therapy. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Being between 18 and 65 years of age. Being diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria. Non-responsiveness to at least one Selective Serotonin Reuptake Inhibitor (SSRI) treatment at an adequate dose and duration. Having 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 maintaining stable doses throughout the study. Providing informed consent and having no contraindications for TMS Exclusion Criteria: Severe neurological disorders (e.g., brain tumor, progressive 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 and neck area, cardiac pacemakers, deep brain stimulation, or vagus nerve stimulation. History of neurosurgical intervention. General contraindications for Transcranial Magnetic Stimulation therapy.

Treatments Being Tested

DEVICE

iTBS TMS

Accelerated intermittent Theta Burst Stimulation (iTBS) will be delivered using a MagVenture MagPro R30 stimulator with a Cool D-B80 double cone coil. The stimulation is targeted at the dorsomedial prefrontal cortex (dmPFC) and anterior cingulate cortex (ACC), specifically 25.8% anterior of the nasion-inion distance. The treatment will be applied at 100% of the motor threshold, which is determined via the Extensor Hallucis Longus muscle. The protocol consists of an intensive 7-day program with 4 sessions per day, totaling 28 sessions. Each session delivers 1,800 pulses and lasts approximately 9 minutes. Patients will continue their stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) throughout the study.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi

Istanbul, Bakirkoy, Turkey (Türkiye)

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07561528), the sponsor (Istanbul University - Cerrahpasa), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07561528 clinical trial studying?

Who can participate in NCT07561528?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07561528?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07561528. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07561528. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.