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Completed

NCT Number: NCT03649685

Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder

This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

The purpose of study is to examine the efficacy of rTMS over different brain areas, including the bilateral supplement motor Area (SMA), the right dorsal lateral prefrontal cortex (DLPFC) and SMA+DLPFC in the treatment of OCD. 120 OCD patients will be randomized into four groups. Continuous theta burst stimulation (cTBS) stimulation will be performed once a day, five times a week, for four weeks. The investigators will assess improvement after four weeks of cTBS. Though the study, Yale-Brown Obsessive Compulsive Scale(Y-BOCS), the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Barratt Impulsiveness Scale-11 (BIS-11), the Beck Depression Inventory(BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale(PSS), Pittsburgh sleep quality index(PSQI), the Obsessive-Compulsive Inventory-Revised(OCI-R) and side effects will be obtained by a trained investigator. The patients will also receive magnetic resonance imaging scan and electroencephalography (EEG).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age>18 years old;
  • DSM-5 criteria for OCD;
  • Y-BOCS total score > or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
  • >or=9 yrs education

Exclusion criteria

  • any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder
  • serious suicide risk;
  • the inability to receive rTMS because of metallic implants, or history of seizures,or history of head injury, or history of neurosurgery;
  • any major medical disease;
  • pregnancy or nursing of an infant;
  • participation in current clinical study;
  • current use of any investigational drug;
  • TMS/DBS treatment at any point in their lifetime;
  • history of long-time use of benzodiazepines

Treatment and study plan

Continuous theta burst stimulation (cTBS)

Device

50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

shame rTMS

Device

The sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS.

Primary outcomes

  1. Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale

    Time frame: Up to 6 months

    The responder on Y-BOCS is defined as a Y-BOCS decrease at least 25% from the baseline at post-treatment

Secondary outcomes

  1. The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)

    Time frame: Up to 6 months

    The DY-BOCS self-report is composed of an 88-item self-report checklist, designed to provide a detailed description of obsessions and compulsions that are divided into six different OC symptom dimensions.

  2. The Barratt Impulsiveness Scale-11 (BIS-11)

    Time frame: Up to 6 months

    It is is an important tool for measuring impulsivity.

  3. The Beck Depression Inventory(BDI)

    Time frame: Up to 6 months

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

  4. The Beck Anxiety Inventory (BAI)

    Time frame: Up to 6 months

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

  5. State-trait Anxiety Inventory(STAI)

    Time frame: Up to 6 months

    It has 20 items for assessing trait anxiety and 20 for state anxiety.

  6. Perceived Stress Scale(PSS)

    Time frame: Up to 6 months

    It is to measure the degree to which situations in one's life are appraised as stressful.

  7. Pittsburgh sleep quality index(PSQI)

    Time frame: Up to 6 months

    It is a self-report questionnaire that assesses sleep quality over a 1-month time interval.

  8. The Obsessive-Compulsive Inventory-Revised(OCI-R)

    Time frame: Up to 6 months

    It's a self-report designed to measure the principal dimensions which characterise obsessive-compulsive disorder.

  9. side effects

    Time frame: Up to 6 months

    It measures side effects including dizziness, headache, itching and so on.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • RenJi Hospital
  • Shanghai 10th People's Hospital

Registry information

Official study title

A Randomized Clinical Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive-Compulsive Disorder

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2018
Registry last updated
May 25, 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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