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

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder

• Registration Number: NCT06692114
• Lead Sponsor: Zhen Wang

Brief 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).

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 Timeline

• Study First Submitted: 2024-08-30
• Study Start: 2024-09-01
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-18
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-06-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Aged between 18 and 50, both genders are welcome.
• DSM-5 criteria for OCD.
• Y-BOCS total score ≥ 16 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS）	Up to 6 weeks	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 responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post- treatment.

Secondary Outcome Measures

Name	Time	Method
Change in The Beck Depression Inventory (BDI)	Up to 6 weeks	It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression.
Change in the The Beck Anxiety Inventory (BAI)	Up to 6 weeks	It is a 21-item self-report inventory that is used for measuring the severity of anxiety

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China