Intermittent Theta Burst Stimulation With Adjunctive D-Cycloserine for Obsessive-Compulsive Disorder: A Randomized Clinical Trial.
Alexander McGirr, Jaeden Cole, Scott B Patten...
https://pubmed.ncbi.nlm.nih.gov/39967412Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07561528
Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy
Led by Istanbul University - Cerrahpasa · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an accelerated intermittent Theta Burst Stimulation (iTBS) protocol, a non-invasive brain stimulation method, for patients with treatment-resistant Obsessive-Compulsive Disorder (OCD). The study aims to assess the effectiveness of targeting the dorsomedial prefrontal cortex (dmPFC) and anterior cingulate cortex (ACC) and to identify electrophysiological biomarkers like EEG microstates and heart rate variability that may predict treatment response. Participants will undergo an intensive 7-day treatment program with 4 iTBS sessions each day, totaling 28 sessions. The stimulation is delivered at 100% of motor threshold using a MagVenture MagPro R30 stimulator with a Cool D-B80 double cone coil, focusing on specific brain regions. Patients will continue their stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) during the trial. During the study, clinical symptoms will be measured before and after treatment using scales such as the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scale. Resting-state EEG and heart rate data are recorded during and after sessions to monitor physiological changes. Follow-up assessments occur at 1, 3, and 6 months post-treatment to evaluate symptom changes and treatment effects.
CONDITIONS
Brief Title
Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Be between 18 and 65 years of age.
- Diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria.
- Have not responded sufficiently to at least one Selective Serotonin Reuptake Inhibitor (SSRI) treatment at an adequate dose and duration.
- Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 20 or higher.
- Have had no changes in current medications for at least the last 2 months and agree to keep doses stable throughout the study.
- Provide informed consent and have no contraindications for Transcranial Magnetic Stimulation (TMS).
You will not qualify if you...
- Have severe neurological disorders or neurodegenerative diseases.
- Have any condition that increases seizure risk.
- Have a history of cochlear implants, metal implants in the head or neck area, cardiac pacemakers, deep brain stimulation, or vagus nerve stimulation.
- Have a history of neurosurgical intervention.
- Have general contraindications for Transcranial Magnetic Stimulation therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 7 days
Participants receive accelerated intermittent Theta Burst Stimulation (iTBS) targeting specific brain areas over an intensive 7-day program with 4 sessions per day.
28 sessions over 7 days
Follow-up
Duration - 6 months
Participants are assessed for treatment response and clinical outcomes after the treatment period.
Visits at 1, 3, and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi
Istanbul, Bakirkoy, Turkey (Türkiye), 34153
Actively Recruiting
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Research Team
S
Sarp Yoldas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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