NCT07198594招募中不适用
A Study on the Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder and Its Underlying Neurological Mechanisms
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- OCD Symptom Severity Assessed by Y-BOCS
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
rTMS
Experimental
individualized rTMS targeting IFC, with symptom provocation
干预措施: rTMS (Other)
结局指标
主要结局
OCD Symptom Severity Assessed by Y-BOCS
时间窗: From Baseline to 6 months after treatment
Change from Baseline to 4 weeks after treatment in OCD Symptom Severity
OCD Symptom Severity Assessed by Y-BOCS
时间窗: From Baseline to 6 months after treatment
Change from Baseline to 4 weeks after treatment in OCD Symptom Severity
次要结局
- Depression Severity Assessed by HAMD(From baseline to 4 weeks after treatment)
- Cognitive Function Assessent by tasks(From baseline to 4 weeks after treatment)
- Safety for rTMS targeting IFC(Adverse Events after treatment)
- Anxitey Severity Assessed by HAMA(From Baseline to 4 weeks after treatment)
- Clinical Efficacy Assessed by CGI(From Baseline to 4 weeks after treatment)
- Uncertainty Assessed by IUI and IUS-12(From Baseline to 4 weeks after treatment)
- Self-rated Beck Depression Inventory (BDI)(From Baseline to 4 weeks after treatment)
- Self-rated State-Trait Anxiety Inventory (STAI)(From Baseline to 4 weeks after treatment)
- Self-rated Short UPPS-P Impulsive Behaviour Scale(From baseline to 4 weeks after treatment)
- Self-rated Short UPPS-P Impulsive Behaviour Scale(From baseline to 4 weeks after treatment)
- Neuroimaging by Magnetic resonance imaging(From baseline to 4 weeks after treatment)
- Safety for rTMS targeting IFC(Adverse Events after treatment)
- Cognitive Function Assessent by tasks(From baseline to 4 weeks after treatment)
- Self-rated State-Trait Anxiety Inventory (STAI)(From Baseline to 4 weeks after treatment)
- Depression Severity Assessed by HAMD(From baseline to 4 weeks after treatment)
- Anxitey Severity Assessed by HAMA(From Baseline to 4 weeks after treatment)
- Clinical Efficacy Assessed by CGI(From Baseline to 4 weeks after treatment)
- Uncertainty Assessed by IUI and IUS-12(From Baseline to 4 weeks after treatment)
- Self-rated Beck Depression Inventory (BDI)(From Baseline to 4 weeks after treatment)
研究者
zhaoyijie
Associate Professor
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
研究点 (2)
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