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NCT Number: NCT06692114

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

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).

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Shanghai Center

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD

    Time frame: baseline,2 weeks, 4 weeks

    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)

  2. Change in The Beck Depression Inventory (BDI)

    Time frame: baseline,2 weeks, 4 weeks

    It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression.

  3. Change in the The Beck Anxiety Inventory (BAI)

    Time frame: baseline,2 weeks, 4 weeks

    It is a 21-item self-report inventory that is used for measuring the severity of anxiety

Other outcomes

  1. Attention Network Task (ANT)

    Time frame: Up to 2 weeks

    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.

  2. Rapid Serial Visual Presentation (RSVP)

    Time frame: Up to 2 weeks

    Use programs to rapidly present image stimuli in order to assess patients' attention, recognition, or judgment abilities.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen W Wang, PhD，MD

CONTACT

[email protected]

+86 34773516

Sponsors and collaborators

Lead sponsor

Zhen Wang

Other

Registry information

Official study title

A Preliminary Study on the Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of Obsessive-compulsive Disorder

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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