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

NCT07561528 | Recruiting

• 2 other identifiers: 139589138661
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transcranial Magnetic Stimilation; Obsessive - Compulsive Disorder; Intermittent Theta Burst Stimulation; EEG

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score

  The Y-BOCS is a 10-item clinician-administered scale used to assess the severity of obsessive-compulsive symptoms. Each item is rated from 0 to 4. The total score ranges from 0 to 40, where higher scores indicate greater symptom severity (32-40: extreme, 24-31: severe, 16-23: moderate, 8-15: mild, 0-7: subclinical).

  Change from baseline in clinical scales at the end of the 7-day treatment and at follow-up points (1, 3, and 6 months post-treatment)"

Secondary Outcomes (2)

• EEG Microstate Analysis Parameters

  Baseline, Day 7 (after treatment)

• Frontal-Vagal Activity via Heart Rate Deceleration (HRD)

  During each of the 28 iTBS sessions over the 7-day treatment period

Study Arms (1)

TMS Treatment Arm

ACTIVE COMPARATOR

Device: iTBS TMS

Interventions

iTBS TMS DEVICE

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.

TMS Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No change in the current 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.

You may not qualify if:

• Severe neurological disorders or neurodegenerative diseases.
• Any condition associated with increased seizure risk
• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi

Istanbul, Bakirkoy, 34153, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• McGirr A, Cole J, Patten SB, Adams B. Intermittent Theta Burst Stimulation With Adjunctive D-Cycloserine for Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2025 Mar 1;182(3):307-311. doi: 10.1176/appi.ajp.20240181. Epub 2025 Feb 19. No abstract available.

  PMID: 39967412 BACKGROUND

MeSH Terms

Conditions

Compulsive Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Sarp Yoldas, MD

CONTACT

+905069898506; sarpyoldas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, Resident

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)