Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder

Официальное название

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

Обзор

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

Вмешательства

• Другое rTMS
  individualized rTMS target the IFC with symptom provocation

Первичные конечные точки

• OCD Symptom Severity Assessed by Y-BOCS [Срок оценки: From Baseline to 6 months after treatment]

Вторичные конечные точки (10)

• Safety for rTMS targeting IFC [Срок оценки: Adverse Events after treatment]
• Depression Severity Assessed by HAMD [Срок оценки: From baseline to 4 weeks after treatment]
• Anxitey Severity Assessed by HAMA [Срок оценки: From Baseline to 4 weeks after treatment]
• Clinical Efficacy Assessed by CGI [Срок оценки: From Baseline to 4 weeks after treatment]
• Uncertainty Assessed by IUI and IUS-12 [Срок оценки: From Baseline to 4 weeks after treatment]
• Self-rated Beck Depression Inventory (BDI) [Срок оценки: From Baseline to 4 weeks after treatment]
• Self-rated State-Trait Anxiety Inventory (STAI) [Срок оценки: From Baseline to 4 weeks after treatment]
• Self-rated Short UPPS-P Impulsive Behaviour Scale [Срок оценки: From baseline to 4 weeks after treatment]
• Neuroimaging by Magnetic resonance imaging [Срок оценки: From baseline to 4 weeks after treatment]
• Cognitive Function Assessent by tasks [Срок оценки: From baseline to 4 weeks after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Pudong New Area Mental Health Centre — Шанхай

Идентификаторы

NCT: NCT07198594 · PDJW-KY-2025-017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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