An interventional study of Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment) in Obsessive-Compulsive Disorder (OCD), sponsored by Taipei Veterans General Hospital, Taiwan. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment
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.
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
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.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 96 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 338 studies on the registry; 74 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active H7 coil stimulation
Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)
Sham stimulation group
Device: Sham deep TMS (control stimulation) & H7 deep TMS (active treatment) & H1 deep TMS (active treatment)
Active H1 coil group
Device: 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.
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: 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.
Time frame: the 6-week and 8-week
Plan to share: No — Patient privacy
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Obsessive-Compulsive Disorder →
Taipei Veterans General Hospital, Taiwan →