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NCT Number: NCT07198594

Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder

The goal of this clinical trial is to learn if individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation works to treat obsessive-compulsive disorders (OCD) in adults. It will also learn about the safety of rTMS over right IFC. The main questions it aims to answer are:

* Does rTMS using a new individualized IFC target relieve participants' OCD symptoms? * What medical problems do participants have when taking rTMS?

Participants will:

* Take rTMS six times per day for 5 consecutive days * Visit the clinic once at baseline, the day and four weeks after treatment for checkups and tests

Recruiting

Interested in participating?

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Pudong New Area Mental Health Centre

Shanghai, Shanghai Municipality, 200124, China

Location status: Recruiting

Location contact

Ruiqin Chen

CONTACT

[email protected]

+86 13917451850

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria
  • without associated tics ("Gilles de la Tourette" Syndrome)
  • Age 18-60 years, right-handed
  • Disease severity: Yale-Brown Obsessive Compulsive Scale score ≥16 for OCD patients
  • Medication stable for at least 4 weeks
  • Resistant patients to standard treatments: partial but insufficient response (reduction of Y-BOCS score < 35%) or lack of response to previous well conducted treatment including: optimal tolerated dose and adequate duration (> 12 weeks) of at least 2 Serotonin Reuptake Inhibitors (selective serotonin reuptake inhibitors, clomipramine), or 1 Serotonin Reuptake Inhibitors + 1 augmentation strategy (adjunction of an antipsychotic - such as risperidone or olanzapine or aripiprazole - or lithium or buspirone)
  • No systematic rTMS therapy in the past six months;
  • Signature of informed consent form;
  • Normal vision or corrected vision;
  • Capacity to complete protocol-specified tests.

Exclusion criteria

  • Abnormal cognitive status (assessed using MoCA with score <24);
  • Other primary diagnosis than OCD (comorbid mild depression is tolerated)
  • Comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance3)
  • Significant self-harm intent or severe suicidal tendencies within the past year;
  • Irreversible visual or auditory impairment preventing completion of scales or related assessments;
  • Presence of metallic implants, such as pacemakers or stents;
  • Any current or potential medical, psychological, social, or geographical factors compromising patient safety or study participation;
  • Poor compliance;
  • Claustrophobia;
  • History of epilepsy or familial epilepsy
  • Pregnant or lactating women (women of childbearing potential must obtain a negative pregnancy test result prior to study commencement and employ medically approved contraceptive measures);
  • Deterioration or failure of vital organ function (cardiac, pulmonary, hepatic, renal, etc.); or unstable vital signs;
  • Conditions unsuitable for this stimulation site, such as increased intracranial pressure, elevated intraocular pressure, or glaucoma
  • History of or concomitant neurological disorders: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, Lewy body dementia, traumatic brain injury dementia, other physical/chemical factors (drugs, alcohol, CO, etc.), significant somatic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural haematoma, brain tumours), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiency or any other cause

Treatment and study plan

rTMS

Other

individualized rTMS target the IFC with symptom provocation

Primary outcomes

  1. OCD Symptom Severity Assessed by Y-BOCS

    Time frame: From Baseline to 6 months after treatment

    Change from Baseline to 4 weeks after treatment in OCD Symptom Severity

Secondary outcomes

  1. Safety for rTMS targeting IFC

    Time frame: Adverse Events after treatment

    Number of Participants with Treatment-Related Adverse Events

  2. Depression Severity Assessed by HAMD

    Time frame: From baseline to 4 weeks after treatment

  3. Anxitey Severity Assessed by HAMA

    Time frame: From Baseline to 4 weeks after treatment

  4. Clinical Efficacy Assessed by CGI

    Time frame: From Baseline to 4 weeks after treatment

  5. Uncertainty Assessed by IUI and IUS-12

    Time frame: From Baseline to 4 weeks after treatment

  6. Self-rated Beck Depression Inventory (BDI)

    Time frame: From Baseline to 4 weeks after treatment

  7. Self-rated State-Trait Anxiety Inventory (STAI)

    Time frame: From Baseline to 4 weeks after treatment

  8. Self-rated Short UPPS-P Impulsive Behaviour Scale

    Time frame: From baseline to 4 weeks after treatment

  9. Neuroimaging by Magnetic resonance imaging

    Time frame: From baseline to 4 weeks after treatment

  10. Cognitive Function Assessent by tasks

    Time frame: From baseline to 4 weeks after treatment

    Including Cantab and coded tasks in Matlab

Study contacts

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

Yijie Zhao

CONTACT

[email protected]

+86 13585960699

Sponsors and collaborators

Lead sponsor

Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

Other

Registry information

Official study title

A Study on the Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder and Its Underlying Neurological Mechanisms

Acronym: OCDTMS-IFC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Sep 30, 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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