A Preliminary Study on the Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of Obsessive-compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
active treatment group
The resting motor threshold (RMT) of the patient was measured before the first treatment. Symptom induction was performed before each treatment to achieve moderate anxiety in patients. The magnetic stimulation intensity was 100% RMT, using the deep transcranial magnetic stimulation coil H7 for treatment, with the stimulation area being the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC). Treatment was administered twice daily for 20 minutes each time for 2 weeks.
干预措施: Deep Transcranial Magnetic Stimulation, DTMS active (Device)
sham group
The same RMT test as the active treatment group was accepted, and symptom induction was performed before treatment to achieve moderate anxiety. During treatment, the coil in the shame treatment group only produces sound and scalp vibration, and does not generate a real magnetic field. There is no other difference between the two coils. The frequency and number of treatments were the same as those in the active treatment group.
干预措施: Deep Transcranial Magnetic Stimulation, DTMS sham (Device)
结局指标
主要结局
To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD
时间窗: baseline,2weeks,4weeks
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe. The primary outcome measure percent reduction of Y-BOCS scores at completion of the dTMS treatment.
次要结局
- To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD(baseline,2 weeks, 4 weeks)
- Change in The Beck Depression Inventory (BDI)(baseline,2 weeks, 4 weeks)
- Change in the The Beck Anxiety Inventory (BAI)(baseline,2 weeks, 4 weeks)
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center