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Recruiting NCT06692114

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

No phase Interventional Obsessive-Compulsive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Transcranial Magnetic Stimulation, DTMS active, Deep Transcranial Magnetic Stimulation, DTMS sham.
Who it may be relevant to
Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD [Time frame: baseline,2weeks,4weeks]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Mental Health Center — Shanghai

Identifiers

NCT: NCT06692114 · SMHC-OCD-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗