Obsessive Compulsive Disorder (OCD)OCDTMS-IFCNCT07198594
Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder
A study testing rTMS in people with Obsessive Compulsive Disorder (OCD) and Obsessive - Compulsive Disorder, run by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation works to treat obsessive-compulsive disorders (OCD) in adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD), Obsessive - Compulsive Disorder
- What is being tested?
- rTMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria
- without associated tics ("Gilles de la Tourette" Syndrome)
- Age 18-60 years, right-handed
- Disease severity: Yale-Brown Obsessive Compulsive Scale score ≥16 for OCD patients
- Medication stable for at least 4 weeks
- Resistant patients to standard treatments: partial but insufficient response (reduction of Y-BOCS score < 35%) or lack of response to previous well conducted treatment including: optimal tolerated dose and adequate duration (> 12 weeks) of at least 2 Serotonin Reuptake Inhibitors (selective serotonin reuptake inhibitors, clomipramine), or 1 Serotonin Reuptake Inhibitors + 1 augmentation strategy (adjunction of an antipsychotic - such as risperidone or olanzapine or aripiprazole - or lithium or buspirone)
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- No systematic rTMS therapy in the past six months;
- Signature of informed consent form;
- Normal vision or corrected vision;
- Capacity to complete protocol-specified tests.
Who cannot join
- Abnormal cognitive status (assessed using MoCA with score <24);
- Other primary diagnosis than OCD (comorbid mild depression is tolerated)
- Comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance3)
- Significant self-harm intent or severe suicidal tendencies within the past year;
- Irreversible visual or auditory impairment preventing completion of scales or related assessments;
- Presence of metallic implants, such as pacemakers or stents;
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- Any current or potential medical, psychological, social, or geographical factors compromising patient safety or study participation;
- Poor compliance;
- Claustrophobia;
- History of epilepsy or familial epilepsy
- Pregnant or lactating women (women of childbearing potential must obtain a negative pregnancy test result prior to study commencement and employ medically approved contraceptive measures);
- Deterioration or failure of vital organ function (cardiac, pulmonary, hepatic, renal, etc.); or unstable vital signs;
- Conditions unsuitable for this stimulation site, such as increased intracranial pressure, elevated intraocular pressure, or glaucoma
- History of or concomitant neurological disorders: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, Lewy body dementia, traumatic brain injury dementia, other physical/chemical factors (drugs, alcohol, CO, etc.), significant somatic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural haematoma, brain tumours), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiency or any other cause
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pudong New Area Mental Health Centre
Shanghai, Shanghai Municipality, 200124
Ruiqin Chen, +86 13917451850, chenrq@shspdjw.com
About this study
Official title: A Study on the Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder and Its Underlying Neurological Mechanisms
The goal of this clinical trial is to learn if individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation works to treat obsessive-compulsive disorders (OCD) in adults. It will also learn about the safety of rTMS over right IFC. The main questions it aims to answer are:
- Does rTMS using a new individualized IFC target relieve participants' OCD symptoms?
- What medical problems do participants have when taking rTMS?
Participants will:
- Take rTMS six times per day for 5 consecutive days
- Visit the clinic once at baseline, the day and four weeks after treatment for checkups and tests
- Being tested
- rTMS
- Medical subject headings
- Obsessive-Compulsive Disorder, Compulsive Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSOther
individualized rTMS target the IFC with symptom provocation
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | individualized rTMS targeting IFC, with symptom provocation Receives: Other: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCD Symptom Severity Assessed by Y-BOCS
Change from Baseline to 4 weeks after treatment in OCD Symptom Severity
Measured: From Baseline to 6 months after treatment
Secondary outcomes (10)
Safety for rTMS targeting IFC
Number of Participants with Treatment-Related Adverse Events
Measured: Adverse Events after treatment
Depression Severity Assessed by HAMD
Measured: From baseline to 4 weeks after treatment
Anxitey Severity Assessed by HAMA
Measured: From Baseline to 4 weeks after treatment
Clinical Efficacy Assessed by CGI
Measured: From Baseline to 4 weeks after treatment
Uncertainty Assessed by IUI and IUS-12
Measured: From Baseline to 4 weeks after treatment
Self-rated Beck Depression Inventory (BDI)
Measured: From Baseline to 4 weeks after treatment
Self-rated State-Trait Anxiety Inventory (STAI)
Measured: From Baseline to 4 weeks after treatment
Self-rated Short UPPS-P Impulsive Behaviour Scale
Measured: From baseline to 4 weeks after treatment
Neuroimaging by Magnetic resonance imaging
Measured: From baseline to 4 weeks after treatment
Cognitive Function Assessent by tasks
Including Cantab and coded tasks in Matlab
Measured: From baseline to 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start3 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhaoyijie, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198594
- Sponsor's protocol ID
- PDJW-KY-2025-017
- Acronym
- OCDTMS-IFC
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder and Its Underlying Neurological Mechanisms
- ClinicalTrials.gov ID
- NCT07198594
- Acronym / sponsor ID
- OCDTMS-IFC / PDJW-KY-2025-017
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji UniversityUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 2025 (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 goal of this clinical trial is to learn if individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation works to treat obsessive-compulsive disorders (OCD) in adults. It will also learn about the safety of rTMS over right IFC. The main questions it aims to answer are:
- Does rTMS using a new individualized IFC target relieve participants' OCD symptoms?
- What medical problems do participants have when taking rTMS?
Participants will:
- Take rTMS six times per day for 5 consecutive days
- Visit the clinic once at baseline, the day and four weeks after treatment for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Other: rTMSindividualized rTMS targeting IFC, with symptom provocation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria
- without associated tics ("Gilles de la Tourette" Syndrome)
- Age 18-60 years, right-handed
- Disease severity: Yale-Brown Obsessive Compulsive Scale score ≥16 for OCD patients
- Medication stable for at least 4 weeks
Key exclusion criteria (14 listed)
- Abnormal cognitive status (assessed using MoCA with score <24);
- Other primary diagnosis than OCD (comorbid mild depression is tolerated)
- Comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance3)
- Significant self-harm intent or severe suicidal tendencies within the past year;
- Irreversible visual or auditory impairment preventing completion of scales or related assessments;
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 |
|---|---|---|
| rTMSindividualized rTMS target the IFC with symptom provocation | Other | rTMS |
Primary outcome
OCD Symptom Severity Assessed by Y-BOCS
Time frame: From Baseline to 6 months after treatment
Change from Baseline to 4 weeks after treatment in OCD Symptom Severity
10 secondary outcomes
Safety for rTMS targeting IFC
Time frame: Adverse Events after treatment
Depression Severity Assessed by HAMD
Time frame: From baseline to 4 weeks after treatment
Anxitey Severity Assessed by HAMA
Time frame: From Baseline to 4 weeks after treatment
Clinical Efficacy Assessed by CGI
Time frame: From Baseline to 4 weeks after treatment
Uncertainty Assessed by IUI and IUS-12
Time frame: From Baseline to 4 weeks after treatment
Self-rated Beck Depression Inventory (BDI)
Time frame: From Baseline to 4 weeks after treatment
Self-rated State-Trait Anxiety Inventory (STAI)
Time frame: From Baseline to 4 weeks after treatment
Self-rated Short UPPS-P Impulsive Behaviour Scale
Time frame: From baseline to 4 weeks after treatment
Neuroimaging by Magnetic resonance imaging
Time frame: From baseline to 4 weeks after treatment
Cognitive Function Assessent by tasks
Time frame: From baseline to 4 weeks after treatment
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 30 Sep 2025.
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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 rTMS in people with Obsessive Compulsive Disorder (OCD) and Obsessive - Compulsive Disorder, run by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University at 1 site in China.
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 10 inclusion and 14 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 30 Sep 2025. 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 China. 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 Yijie Zhao (+86 13585960699, yj_zhao@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCD Symptom Severity Assessed by Y-BOCS (time frame: From Baseline to 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.