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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Transcranial Magnetic Stimulation, DTMS active | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline,2weeks,4weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline,2 weeks, 4 weeks |
| Change in The Beck Depression Inventory (BDI) |
| Measure | Description | Time Frame |
|---|---|---|
| Attention Network Task (ANT) | Have patients allocate their attention and process information through tasks processed by a grid structure. Monitor whether there are any changes in patients' attention after treatment. | Up to 2 weeks |
| Rapid Serial Visual Presentation (RSVP) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen W Wang, PhD，MD | Contact | +86 34773516 | wangzhen@smhc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhen Wang, PhD，MD | Study Principal Investigato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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Randomized Controlled Trial
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| Deep Transcranial Magnetic Stimulation, DTMS sham | Device | 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. |
|
It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression. |
| 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 | baseline,2 weeks, 4 weeks |
Use programs to rapidly present image stimuli in order to assess patients' attention, recognition, or judgment abilities. |
| Up to 2 weeks |