Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of OCD

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).

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Deep Transcranial Magnetic Stimulation, DTMS active; Device: Deep Transcranial Magnetic Stimulation, DTMS sham

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen W Wang, PhD，MD; Phone Number: +86 34773516; Email: wangzhen@smhc.org.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Shanghai Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Has implanted medical devices such as intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, etc.
• Serious suicide risk.
• Pregnancy or nursing of an infant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active treatment group; 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.	Device: Deep Transcranial Magnetic Stimulation, DTMS active; 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.
Sham Comparator: sham group; 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.	Device: Deep Transcranial Magnetic Stimulation, DTMS sham; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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)	Use programs to rapidly present image stimuli in order to assess patients' attention, recognition, or judgment abilities.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: zhen wang
• Investigators: Principal Investigator: Zhen Wang, PhD，MD, Study Principal Investigato

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: deep transcranial magnetic stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: SMHC-OCD-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No