Obsessive - Compulsive DisorderTMS-OCD-EEGNCT07561528
Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder
A study testing iTBS TMS in people with Obsessive - Compulsive Disorder and Transcranial Magnetic Stimilation, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive - Compulsive Disorder, Transcranial Magnetic Stimilation, Intermittent Theta Burst Stimulation
- What is being tested?
- iTBS TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi
Istanbul, Bakirkoy, 34153
Sarp Yoldas, MD, +905069898506, sarpyoldas@gmail.com
About this study
Official title: Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy
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.
Read more
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
- Obsessive - Compulsive Disorder, Transcranial Magnetic Stimilation, Intermittent Theta Burst Stimulation, EEG
- Being tested
- iTBS TMS
- Medical subject headings
- Compulsive Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS TMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TMS Treatment Arm | Active comparator | Not described Receives: Device: iTBS TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Resting-state EEG data will be analyzed using the MICROSTATELAB v2.1 extension for EEGLAB focusing on the four canonical microstate classes labeled A, B, C, and D. For each participant, four specific spatio-temporal parameters will be calculated to evaluate neural dynamics. These include Mean Duration which measures the average lifespan of a specific microstate in milliseconds to represent the stability of neural generators, and Occurrence which measures the average frequency of each microstate per second in Hz to reflect activation tendencies. Additionally, Time Coverage will be calculated as the percentage of total analysis time during which a specific class is dominant, and Transition Probability will be determined to show the likelihood of one microstate class transitioning into another, providing insight into the sequential activation dynamics of the underlying neural networks.
Measured: Baseline, Day 7 (after treatment)
Frontal-Vagal Activity via Heart Rate Deceleration (HRD)
Heart rate data will be recorded using a Polar H10 sensor during iTBS sessions. HRD will be calculated as the change in heart rate (beats per minute - bpm) during the stimulation period compared to the pre-stimulation baseline. Lower heart rate (greater deceleration) is investigated as a predictor of higher fronto-vagal activation and treatment response.
Measured: During each of the 28 iTBS sessions over the 7-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jan 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarp Yoldas, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561528
- Sponsor's protocol ID
- 1395891
- Other IDs
- 38661
- Acronym
- TMS-OCD-EEG
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 39967412
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy
- ClinicalTrials.gov ID
- NCT07561528
- Acronym / sponsor ID
- TMS-OCD-EEG / 1395891
- Conditions
- Obsessive - Compulsive Disorder, Transcranial Magnetic Stimilation, Intermittent Theta Burst Stimulation, EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS Treatment Arm | Active comparator | Device: iTBS TMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTBS TMSAccelerated 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. | Device | TMS Treatment Arm |
Primary outcome
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)"
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 39967412McGirr 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS TMS in people with Obsessive - Compulsive Disorder and Transcranial Magnetic Stimilation, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarp Yoldas, MD (+905069898506, sarpyoldas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.