Obsessive-Compulsive Disorder (OCD)NCT07587112
Explore Neural Mechanism of Obsessive-Compulsive Disorder (OCD) by Intervention of Repetitive Transcranial Magnetic Stimulation With Symptom Provocation
A study of Obsessive-Compulsive Disorder (OCD), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the differences in therapeutic efficacy of different deep Transcranial Magnetic Stimulation (deep TMS) treatment coils and different brain stimulation targets on obsessive-compulsive symptoms, and to explore the neural mechanisms of obsessive-compulsive disorder using… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Sep 2025to 31 Dec 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
- Adults aged 18-65 years.
- Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria. Treatment resistance (i.e., inadequate response to pharmacological or non-pharmacological treatments) is not required.
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 14, indicating at least mild to moderate symptom severity.
Who cannot join
- Diagnosis of schizophrenia, organic psychotic disorder, bipolar disorder, alcohol use disorder, or substance use disorder.
- High suicide risk within the past year.
- Presence of significant medical or surgical conditions in an active phase.
- History of, or planned, neurosurgical procedures, or presence of metallic implants in the brain or body (e.g., neurostimulators or cardiac pacemakers).
- Structural brain abnormalities (e.g., brain tumor or arteriovenous malformation) or neurological disorders (e.g., meningitis, encephalitis, stroke, or epilepsy).
- Pregnant women.
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- Inability to tolerate PET/MRI examination due to claustrophobia or severe anxiety in confined spaces.
- Any other conditions that may impair study compliance, including inability to cooperate, failure to provide informed consent, or other investigator-determined ineligibility after screening.
- Use of medications that may increase seizure risk or suicide risk (e.g., certain antidepressants or antipsychotics).
- Known allergy to 18F-FDG (18F-2-Fluoro-2-DeoxyGlucose).
- History of adverse reaction to TMS or allergy to the positioning cap.
- Presence of metallic objects within approximately 30 cm of the cranial region (within the stimulation coil area).
- Prior or current treatment with electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chia-Min Huang contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei
Cheng-Ta Li, 886-2-55704055, ctli0420@gmail.com
Chia-Min Huang, psygrace1@gmail.com
About this study
The purpose of this study is to investigate the differences in therapeutic efficacy of different deep Transcranial Magnetic Stimulation (deep TMS) treatment coils and different brain stimulation targets on obsessive-compulsive symptoms, and to explore the neural mechanisms of obsessive-compulsive disorder using functional neuroimaging analysis.
- Inclusion Criteria: Adults aged 18-65 years. Patients diagnosed with obsessive-compulsive disorder according to DSM-5 criteria.
- Study Design: Double-blind, randomized assignment.
- Number of Participants: Sham group: 32 participants Active H7 group: 32 participants Active H1 group: 32 participants Total: 96 participants
- Study Procedures:
Read more
- Participant Screening and Baseline Assessment (Week 0) Determine eligibility for enrollment, including diagnostic confirmation, symptom assessment, screening for contraindications, and whether the participant has previously experienced adverse effects following TMS treatment. Participants with high suicide risk within the past year will be excluded. Develop a personalized symptom provocation procedure for obsessive-compulsive symptoms. Complete baseline symptom severity assessments and brain positron emission tomography/magnetic resonance imaging (PET/MRI). Participants with structural brain abnormalities will be excluded. Participants will be randomly assigned (1:1:1) into three groups, with a planned total enrollment of 96 participants. Participants currently taking medication may continue their existing regimen, but no medication changes will be allowed during the study period.
- Treatment Phase (Week 1 to Week 6; duration: 6 weeks) Before each TMS session, participants will remove their shoes and socks, rest both hands flat on their thighs, keep their eyes looking straight ahead, and undergo measurement of resting motor threshold (RMT). Approximately 3-5 minutes before each TMS session, trained personnel with Exposure and Response Prevention (ERP) experience will assist participants in symptom provocation and record the participant's subjective level of distress. The deep TMS treatment schedule consists of five sessions per week, one session per day, for six consecutive weeks. Adverse effects will be assessed and monitored at each session. After completing the first treatment session, participants will be asked to guess which group they were assigned to, in order to evaluate the effect of treatment expectations on outcomes. Symptom severity interviews will be conducted every two weeks.
- Post-treatment Assessment and Follow-up (Week 7 and after; duration: 2 weeks, then 6 months later) Within one week after completion of the deep TMS treatment course (within Week 7), participants will undergo follow-up brain PET/MRI. At the end of Week 8 (two weeks after treatment completion), symptom severity will be reassessed. Subsequent treatment plans will be discussed with participants, and outpatient follow-up will be arranged within six months. Subsequent treatment options may include cognitive behavioral therapy, pharmacotherapy, and figure-8 rTMS.
- Statistical Analysis
- Expected Outcomes:
The H7 coil may improve obsessive-compulsive symptoms. Both the H7 and H1 coils may improve mood symptoms.
- Descriptive and Inferential Statistics: Analysis of covariance (ANCOVA) will be used to compare differences among the three groups in Montgomery-Asberg Depression Rating Scale (MADRS), Yale-Brown obsessive compulsive scale (Y-BOCS), Hamilton Anxiety Scale (HAM-A), Hamilton Depression Scale (HDRS), and Clinical Global Impression (CGI-S) scores.
The percentage of responders (% responders) will be calculated and compared among groups.
Repeated-measures ANOVA will be used to examine within-group and between-group differences in symptom improvement before and after deep TMS treatment.
Pearson correlation analysis will be used to assess the association between symptom improvement and changes observed in PET/MRI neuroimaging measures.
- PET/MRI Neuroimaging Analysis: Functional MRI analyses will include ROI-to-ROI functional connectivity and seed-based functional connectivity analyses.
Changes in PET glucose uptake within specific regions of interest (ROIs) will also be examined to evaluate alterations in neural networks and brain function before and after deep TMS treatment.
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Being tested
- Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)Device
Sham dTMS Participants will receive sham deep TMS using a sham coil.
H7 dTMS Participants will receive active deep TMS using the H7 coil.
H1 dTMS Participants will receive active deep TMS using the H1 coil.
| Study group | Role | What they receive |
|---|---|---|
| Active H7 coil stimulation | Experimental | Active H7 coil stimulation Receives: Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment) |
| Sham stimulation group | Sham comparator | Sham stimulation group Receives: Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment) |
| Active H1 coil group | Experimental | Active H1 coil group Receives: Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage changes in Y-BOCS scores after treatments
Two time-spans are assessed: (a) from baseline (Week 0, W0) to posttreatment (Week 6, W6), and (b) from baseline (W0) to the 2-week follow-up (Week 8, W8). The percentage changes in Y-BOCS scores will be calculated as follows:
- percent of YBOCS6-0 = (W6 - W0) / W0
- percent of YBOCS8-0 = (W8 - W0) / W0 A full treatment response, defined as a ≥30 percent reduction in Y-BOCS score from baseline, will be evaluated at both the 6-week and 8-week time points.
Measured: the 6-week and 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start22 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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 Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587112
- Sponsor's protocol ID
- 2024-06-004C
- Status last verified
- Jul 2026
- First submitted
- 8 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy
Publications
Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan-Feb;11(1):158-165. doi: 10.1016/j.brs.2017.09.004. Epub 2017 Sep 6.
PubMed 28927961
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore Neural Mechanism of Obsessive-Compulsive Disorder (OCD) by Intervention of Repetitive Transcranial Magnetic Stimulation With Symptom Provocation
- ClinicalTrials.gov ID
- NCT07587112
- Acronym / sponsor ID
- 2024-06-004C
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 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.
The purpose of this study is to investigate the differences in therapeutic efficacy of different deep Transcranial Magnetic Stimulation (deep TMS) treatment coils and different brain stimulation targets on obsessive-compulsive symptoms, and to explore the neural mechanisms of obsessive-compulsive disorder using functional neuroimaging analysis.
- Inclusion Criteria: Adults aged 18-65 years. Patients diagnosed with obsessive-compulsive disorder according to DSM-5 criteria.
- Study Design: Double-blind, randomized assignment.
- Number of Participants: Sham group: 32 participants Active H7 group: 32 participants Active H1 group: 32 participants Total: 96 participants
- Study Procedures:
- Participant Screening and Baseline Assessment (Week 0) Determine eligibility for enrollment, including diagnostic confirmation, symptom assessment, screening for contraindications, and whether the participant has previously experienced adverse effects following TMS treatment. Participants with high suicide risk within the past year will be excluded. Develop a personalized symptom provocation procedure for obsessive-compulsive symptoms. Complete baseline symptom severity assessments and brain positron emission tomography/magnetic resonance imaging (PET/MRI). Participants with structural brain abnormalities will be excluded. Participants will be randomly assigned (1:1:1) into three groups, with a planned total enrollment of 96 participants. Participants currently taking medication may continue their existing regimen, but no medication changes will be allowed during the study period.
- Treatment Phase (Week 1 to Week 6; duration: 6 weeks) Before each TMS session, participants will remove their shoes and socks, rest both hands flat on their thighs, keep their eyes looking straight ahead, and undergo measurement of resting motor threshold (RMT). Approximately 3-5 minutes before each TMS session, trained personnel with Exposure and Response Prevention (ERP) experience will assist participants in symptom provocation and record the participant's subjective level of distress. The deep TMS treatment schedule consists of five sessions per week, one session per day, for six consecutive weeks. Adverse effects will be assessed and monitored at each session. After completing the first treatment session, participants will be asked to guess which group they were assigned to, in order to evaluate the effect of treatment expectations on outcomes. Symptom severity interviews will be conducted every two weeks.
- Post-treatment Assessment and Follow-up (Week 7 and after; duration: 2 weeks, then 6 months later) Within one week after completion of the deep TMS treatment course (within Week 7), participants will undergo follow-up brain PET/MRI. At the end of Week 8 (two weeks after treatment completion), symptom severity will be reassessed. Subsequent treatment plans will be discussed with participants, and outpatient follow-up will be arranged within six months. Subsequent treatment options may include cognitive behavioral therapy, pharmacotherapy, and figure-8 rTMS.
- Statistical Analysis
- Expected Outcomes:
The H7 coil may improve obsessive-compulsive symptoms. Both the H7 and H1 coils may improve mood symptoms.
- Descriptive and Inferential Statistics: Analysis of covariance (ANCOVA) will be used to compare differences among the three groups in Montgomery-Asberg Depression Rating Scale (MADRS), Yale-Brown obsessive compulsive scale (Y-BOCS), Hamilton Anxiety Scale (HAM-A), Hamilton Depression Scale (HDRS), and Clinical Global Impression (CGI-S) scores.
The percentage of responders (% responders) will be calculated and compared among groups.
Repeated-measures ANOVA will be used to examine within-group and between-group differences in symptom improvement before and after deep TMS treatment.
Pearson correlation analysis will be used to assess the association between symptom improvement and changes observed in PET/MRI neuroimaging measures.
- PET/MRI Neuroimaging Analysis: Functional MRI analyses will include ROI-to-ROI functional connectivity and seed-based functional connectivity analyses.
Changes in PET glucose uptake within specific regions of interest (ROIs) will also be examined to evaluate alterations in neural networks and brain function before and after deep TMS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active H7 coil stimulation | Experimental | Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)Active H7 coil stimulation |
| Sham stimulation group | Sham comparator | Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)Sham stimulation group |
| Active H1 coil group | Experimental | Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)Active H1 coil group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 years.
- Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria. Treatment resistance (i.e., inadequate response to pharmacological or non-pharmacological treatments) is not required.
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 14, indicating at least mild to moderate symptom severity.
Key exclusion criteria (13 listed)
- Diagnosis of schizophrenia, organic psychotic disorder, bipolar disorder, alcohol use disorder, or substance use disorder.
- High suicide risk within the past year.
- Presence of significant medical or surgical conditions in an active phase.
- History of, or planned, neurosurgical procedures, or presence of metallic implants in the brain or body (e.g., neurostimulators or cardiac pacemakers).
- Structural brain abnormalities (e.g., brain tumor or arteriovenous malformation) or neurological disorders (e.g., meningitis, encephalitis, stroke, or epilepsy).
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 |
|---|---|---|
| Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)Sham dTMS Participants will receive sham deep TMS using a sham coil. H7 dTMS Participants will receive active deep TMS using the H7 coil. H1 dTMS Participants will receive active deep TMS using the H1 coil. | Device | Active H1 coil group, Active H7 coil stimulation, Sham stimulation group |
Primary outcome
the percentage changes in Y-BOCS scores after treatments
Time frame: the 6-week and 8-week
Two time-spans are assessed: (a) from baseline (Week 0, W0) to posttreatment (Week 6, W6), and (b) from baseline (W0) to the 2-week follow-up (Week 8, W8). The percentage changes in Y-BOCS scores will be calculated as follows: 1. percent of YBOCS6-0 = (W6 - W0) / W0 2. percent of YBOCS8-0 = (W8 - W0) / W0 A full treatment response, defined as a ≥30 percent reduction in Y-BOCS score from baseline, will be evaluated at both the 6-week and 8-week time points.
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 6 Jul 2026.
- Background: PubMed 28927961Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan-Feb;11(1):158-165. doi: 10.1016/j.brs.2017.09.004. Epub 2017 Sep 6.
- Individual participant dataSharing planned: No. Patient privacy
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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.
Chia-Min Huang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obsessive-Compulsive Disorder (OCD), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 3 inclusion and 13 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 6 Jul 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 Cheng-Ta Li (886-2-55704055, ctli0420@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage changes in Y-BOCS scores after treatments (time frame: the 6-week and 8-week). 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 NCT07587112, 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 6 Jul 2026.