Obsessive-Compulsive DisorderNCT03649685
Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder
A study testing Continuous theta burst stimulation (cTBS) in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Continuous theta burst stimulation (cTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2019to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 years old;
- DSM-5 criteria for OCD;
- Y-BOCS total score > or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
- >or＝9 yrs education
Who cannot join
- any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder
- serious suicide risk;
- the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
- any major medical disease;
- pregnancy or nursing of an infant;
- participation in current clinical study;
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- current use of any investigational drug;
- TMS/DBS treatment at any point in their lifetime;
- history of long-time use of benzodiazepines
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Randomized Clinical Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive-Compulsive Disorder
This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG.
Read the detailed description
The purpose of study is to examine the efficacy of rTMS over different brain areas, including the bilateral supplement motor Area (SMA), the right dorsal lateral prefrontal cortex (DLPFC) and SMA+DLPFC in the treatment of OCD. 120 OCD patients will be randomized into four groups. Continuous theta burst stimulation (cTBS) stimulation will be performed once a day, five times a week, for four weeks. The investigators will assess improvement after four weeks of cTBS. Though the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Barratt Impulsiveness Scale-11 (BIS-11), the Beck Depression Inventory(BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale(PSS), Pittsburgh sleep quality index(PSQI), the Obsessive-Compulsive Inventory-Revised(OCI-R) and side effects will be obtained by a trained investigator. The patients will also receive magnetic resonance imaging scan and electroencephalography (EEG).
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Continuous theta burst stimulation (cTBS), shame rTMS
- 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.
Continuous theta burst stimulation (cTBS)Device
50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
shame rTMSDevice
The sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS.
| Study group | Role | What they receive |
|---|---|---|
| Group1: rTMS(bilateral SMA) | Active comparator | Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks. Receives: Device: Continuous theta burst stimulation (cTBS) |
| Group2: rTMS(right DLPFC) | Experimental | Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC once a day, 5 days/week, for 4 weeks. Receives: Device: Continuous theta burst stimulation (cTBS) |
| Group3: rTMS(right DLPFC+bilateral SMA) | Experimental | Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC and bilateral SMA once a day, 5 days/week, for 4 weeks. Receives: Device: Continuous theta burst stimulation (cTBS) |
| Group4: shame rTMS | Sham comparator | The sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks. Receives: Device: shame rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment
Measured: Up to 6 months
Secondary outcomes (9)
The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
The DY-BOCS self-report is composed of an 88-item self-report checklist, designed to provide a detailed description of obsessions and compulsions that are divided into six different OC symptom dimensions.
Measured: Up to 6 months
The Barratt Impulsiveness Scale-11 (BIS-11)
It is is an important tool for measuring impulsivity.
Measured: Up to 6 months
The Beck Depression Inventory(BDI)
It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression.
Measured: Up to 6 months
The Beck Anxiety Inventory (BAI)
It is a 21-item self-report inventory that is used for measuring the severity of anxiety.
Measured: Up to 6 months
State-trait Anxiety Inventory(STAI)
It has 20 items for assessing trait anxiety and 20 for state anxiety.
Measured: Up to 6 months
Perceived Stress Scale(PSS)
It is to measure the degree to which situations in one's life are appraised as stressful.
Measured: Up to 6 months
Pittsburgh sleep quality index(PSQI)
It is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Measured: Up to 6 months
The Obsessive-Compulsive Inventory-Revised(OCI-R)
It's a self-report designed to measure the principal dimensions which characterise obsessive-compulsive disorder.
Measured: Up to 6 months
side effects
It measures side effects including dizziness, headache, itching and so on.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start15 Jul 2019
- Primary completion30 Apr 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanghai 10th People's Hospital
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, PhD,MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649685
- Sponsor's protocol ID
- SMHC-OCD-003
- Status last verified
- Apr 2025
- First submitted
- 23 Aug 2018
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03649685
- Acronym / sponsor ID
- SMHC-OCD-003
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanghai 10th People's Hospital
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 28 Aug 2018 (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.
This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG.
Detailed description
The purpose of study is to examine the efficacy of rTMS over different brain areas, including the bilateral supplement motor Area (SMA), the right dorsal lateral prefrontal cortex (DLPFC) and SMA+DLPFC in the treatment of OCD. 120 OCD patients will be randomized into four groups. Continuous theta burst stimulation (cTBS) stimulation will be performed once a day, five times a week, for four weeks. The investigators will assess improvement after four weeks of cTBS. Though the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Barratt Impulsiveness Scale-11 (BIS-11), the Beck Depression Inventory(BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale(PSS), Pittsburgh sleep quality index(PSQI), the Obsessive-Compulsive Inventory-Revised(OCI-R) and side effects will be obtained by a trained investigator. The patients will also receive magnetic resonance imaging scan and electroencephalography (EEG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1: rTMS(bilateral SMA) | Active comparator | Device: Continuous theta burst stimulation (cTBS)Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks. |
| Group2: rTMS(right DLPFC) | Experimental | Device: Continuous theta burst stimulation (cTBS)Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC once a day, 5 days/week, for 4 weeks. |
| Group3: rTMS(right DLPFC+bilateral SMA) | Experimental | Device: Continuous theta burst stimulation (cTBS)Continuous theta burst stimulation (cTBS) stimulation will be applied over the right DLPFC and bilateral SMA once a day, 5 days/week, for 4 weeks. |
| Group4: shame rTMS | Sham comparator | Device: shame rTMSThe sham rTMS will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age>18 years old;
- DSM-5 criteria for OCD;
- Y-BOCS total score > or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
- >or＝9 yrs education
Key exclusion criteria (9 listed)
- any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder
- serious suicide risk;
- the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
- any major medical disease;
- pregnancy or nursing of an infant;
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 |
|---|---|---|
| Continuous theta burst stimulation (cTBS)50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses | Device | Group1: rTMS(bilateral SMA), Group2: rTMS(right DLPFC), Group3: rTMS(right DLPFC+bilateral SMA) |
| shame rTMSThe sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. | Device | Group4: shame rTMS |
Primary outcome
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
Time frame: Up to 6 months
The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment
9 secondary outcomes
The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
Time frame: Up to 6 months
The Barratt Impulsiveness Scale-11 (BIS-11)
Time frame: Up to 6 months
The Beck Depression Inventory(BDI)
Time frame: Up to 6 months
The Beck Anxiety Inventory (BAI)
Time frame: Up to 6 months
State-trait Anxiety Inventory(STAI)
Time frame: Up to 6 months
Perceived Stress Scale(PSS)
Time frame: Up to 6 months
Pittsburgh sleep quality index(PSQI)
Time frame: Up to 6 months
The Obsessive-Compulsive Inventory-Revised(OCI-R)
Time frame: Up to 6 months
side effects
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 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. This study is not recruiting at the moment.
Zhen Wang, PhD,MD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous theta burst stimulation (cTBS) in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 25 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (time frame: Up to 6 months). 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 25 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.