Obsessive-Compulsive DisorderNCT06692114
Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of OCD
A study testing Deep Transcranial Magnetic Stimulation, DTMS active in people with Obsessive-Compulsive Disorder, run by Zhen Wang at 1 site in China.
Trial summary
This study aims to explore the efficacy and influencing of accelerated dTMS (deep Transcranial Magnetic Stimulation) treatment in patients with obsessive-compulsive disorder (OCD), and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Deep Transcranial Magnetic Stimulation, DTMS active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2024to 1 Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 50, both genders are welcome.
- DSM-5 criteria for OCD.
- Y-BOCS total score ≥ 20 despite therapeutic-dose SRI treatment or completion of at least one full course of CBT. The treatment regimen must have been stable for at least 8 weeks prior to enrollment and remain unchanged throughout the study.
- More than 9 years of education.
- Right-handed.
Who cannot join
- Any additional current psychiatric comorbidity, except for obsessive- compulsive personality disorder.
- Severe obsessive symptoms prevent the completion of necessary assessments.
- Has a history of receiving ECT therapy.
- Has received rTMS or tDCS treatment within the past two months.
- Has severe physical illnesses or any physical conditions that can induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, among others.
- Has a past history of neurological disorders (such as epilepsy, cerebrovascular accidents, etc.) or brain injuries, or a history of brain surgery.
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- Has implanted medical devices such as intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, etc.
- Serious suicide risk.
- Pregnancy or nursing of an infant.
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 Mental Health Center
Shanghai, Shanghai Municipality, 200030
Shanghai Center
About this study
Official title: A Preliminary Study on the Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of Obsessive-compulsive Disorder
This study aims to explore the efficacy and influencing of accelerated dTMS (deep Transcranial Magnetic Stimulation) treatment in patients with obsessive-compulsive disorder (OCD), and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).
Read the detailed description
The study is to recruit eligible patients with obsessive-compulsive disorder (OCD) from the Shanghai Mental Health Center for deep transcranial magnetic stimulation (dTMS) intervention, and recruit healthy controls who meet the enrollment criteria from the community. Among them, patients with OCD will be randomly divided into a real stimulation group and a sham stimulation group. After baseline assessment, dTMS treatment will be administered twice a day. EEG data collection, MRI data, cognitive tasks, psychological self-assessment scales and clinical symptom assessment will be conducted before treatment and 2 weeks after treatment. During the treatment process, patients will receive two treatments per day, each lasting 20 minutes, for a total of 2 weeks, or 28 treatments in total.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Deep Transcranial Magnetic Stimulation, DTMS active, Deep Transcranial Magnetic Stimulation, DTMS sham
- Keywords
- deep transcranial magnetic stimulation
- 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.
Deep Transcranial Magnetic Stimulation, DTMS activeDevice
The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Each treatment stimulates at a frequency of 20 Hz for 2 seconds, with a sequence interval of 20 seconds. Each treatment consists of 50 sequences, for a total of 2000 pulses.
Deep Transcranial Magnetic Stimulation, DTMS shamDevice
The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Compared with active treatment, the sham stimulation coil only produced sound and scalp vibration.
| Study group | Role | What they receive |
|---|---|---|
| active treatment group | Experimental | The resting motor threshold (RMT) of the patient was measured before the first treatment. Symptom induction was performed before each treatment to achieve moderate anxiety in patients. The magnetic stimulation intensity was 100% RMT, using the deep transcranial magnetic stimulation coil H7 for treatment, with the stimulation area being the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC). Treatment was administered twice daily for 20 minutes each time for 2 weeks. Receives: Device: Deep Transcranial Magnetic Stimulation, DTMS active |
| sham group | Sham comparator | The same RMT test as the active treatment group was accepted, and symptom induction was performed before treatment to achieve moderate anxiety. During treatment, the coil in the shame treatment group only produces sound and scalp vibration, and does not generate a real magnetic field. There is no other difference between the two coils. The frequency and number of treatments were the same as those in the active treatment group. Receives: Device: Deep Transcranial Magnetic Stimulation, DTMS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.
The primary outcome measure percent reduction of Y-BOCS scores at completion of the dTMS treatment.
Measured: baseline,2weeks,4weeks
Secondary outcomes (3)
To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD
The secondary outcome measure was the response rate to the treatment, which was defined as a reduction of at least 35% in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: baseline,2 weeks, 4 weeks
Change in 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: baseline,2 weeks, 4 weeks
Change in the The Beck Anxiety Inventory (BAI)
It is a 21-item self-report inventory that is used for measuring the severity of anxiety
Measured: baseline,2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start26 Jul 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, PhD，MD, Principal investigator, Study Principal Investigato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692114
- Sponsor's protocol ID
- SMHC-OCD-012
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2024
- Last updated
- 15 Aug 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT06692114
- Acronym / sponsor ID
- SMHC-OCD-012
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- deep transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zhen WangUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 Nov 2024 (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 aims to explore the efficacy and influencing of accelerated dTMS (deep Transcranial Magnetic Stimulation) treatment in patients with obsessive-compulsive disorder (OCD), and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).
Detailed description
The study is to recruit eligible patients with obsessive-compulsive disorder (OCD) from the Shanghai Mental Health Center for deep transcranial magnetic stimulation (dTMS) intervention, and recruit healthy controls who meet the enrollment criteria from the community. Among them, patients with OCD will be randomly divided into a real stimulation group and a sham stimulation group. After baseline assessment, dTMS treatment will be administered twice a day. EEG data collection, MRI data, cognitive tasks, psychological self-assessment scales and clinical symptom assessment will be conducted before treatment and 2 weeks after treatment. During the treatment process, patients will receive two treatments per day, each lasting 20 minutes, for a total of 2 weeks, or 28 treatments in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| active treatment group | Experimental | Device: Deep Transcranial Magnetic Stimulation, DTMS activeThe resting motor threshold (RMT) of the patient was measured before the first treatment. Symptom induction was performed before each treatment to achieve moderate anxiety in patients. The magnetic stimulation intensity was 100% RMT, using the deep transcranial magnetic stimulation coil H7 for treatment, with the stimulation area being the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC). Treatment was administered twice daily for 20 minutes each time for 2 weeks. |
| sham group | Sham comparator | Device: Deep Transcranial Magnetic Stimulation, DTMS shamThe same RMT test as the active treatment group was accepted, and symptom induction was performed before treatment to achieve moderate anxiety. During treatment, the coil in the shame treatment group only produces sound and scalp vibration, and does not generate a real magnetic field. There is no other difference between the two coils. The frequency and number of treatments were the same as those in the active treatment group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 and 50, both genders are welcome.
- DSM-5 criteria for OCD.
- Y-BOCS total score ≥ 20 despite therapeutic-dose SRI treatment or completion of at least one full course of CBT. The treatment regimen must have been stable for at least 8 weeks prior to enrollment and remain unchanged throughout the study.
- More than 9 years of education.
- Right-handed.
Key exclusion criteria (9 listed)
- Any additional current psychiatric comorbidity, except for obsessive- compulsive personality disorder.
- Severe obsessive symptoms prevent the completion of necessary assessments.
- Has a history of receiving ECT therapy.
- Has received rTMS or tDCS treatment within the past two months.
- Has severe physical illnesses or any physical conditions that can induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, among others.
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 |
|---|---|---|
| Deep Transcranial Magnetic Stimulation, DTMS activeThe treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Each treatment stimulates at a frequency of 20 Hz for 2 seconds, with a sequence interval of 20 seconds. Each treatment consists of 50 sequences, for a total of 2000 pulses. | Device | active treatment group |
| Deep Transcranial Magnetic Stimulation, DTMS shamThe treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Compared with active treatment, the sham stimulation coil only produced sound and scalp vibration. | Device | sham group |
Primary outcome
To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD
Time frame: baseline,2weeks,4weeks
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe. The primary outcome measure percent reduction of Y-BOCS scores at completion of the dTMS treatment.
3 secondary outcomes
To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD
Time frame: baseline,2 weeks, 4 weeks
Change in The Beck Depression Inventory (BDI)
Time frame: baseline,2 weeks, 4 weeks
Change in the The Beck Anxiety Inventory (BAI)
Time frame: baseline,2 weeks, 4 weeks
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 15 Aug 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.
Zhen Wang, PhD，MD principal investigator
Study Principal Investigato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Transcranial Magnetic Stimulation, DTMS active in people with Obsessive-Compulsive Disorder, run by Zhen Wang 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 5 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: looking for participants now, as of the sponsor's last update on 15 Aug 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?
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 Zhen W Wang, PhD，MD (+86 34773516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD (time frame: baseline,2weeks,4weeks). 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 15 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.