Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iTBS TMS.
- Who it may be relevant to
- Registry conditions: Obsessive - Compulsive Disorder, Transcranial Magnetic Stimilation, Intermittent Theta Burst Stimulation, EEG. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy
Overview
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.
Interventions
- 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
Primary outcome measures
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score [Time frame: 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 outcome measures (2)
- EEG Microstate Analysis Parameters [Time frame: Baseline, Day 7 (after treatment)]
- Frontal-Vagal Activity via Heart Rate Deceleration (HRD) [Time frame: During each of the 28 iTBS sessions over the 7-day treatment period]
Eligibility criteria
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.
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi — Istanbul
Publications
- 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
Identifiers
NCT: NCT07561528 · 1395891 · 38661