A Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- SANS
研究概览
简要总结
Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics.
Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have PANSS negative≥21 and PANSS positive<24. Patients will be recruited from both academic and private research centers.
Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.
Concurrent Control: The study group will receive active rTMS treatment and the control group will receive an inactive, sham treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
- •Right hand dominant.
- •Scores in PANSS negative questionnaire above
- •Gave informed consent for participation in the study.
- •Negative answers on safety screening questionnaire for transcranial magnetic stimulation
- •stable on the same antipsychotic medication for at least two months prior to entering the study.
- •Negative answers to all questions in the TMS safety questionnaire (attached ).
排除标准
- •Diagnosed as suffering from another axis 1 disorder .
- •Scores in PANSS positive questionnaire above
- •History of epilepsy, seizure, or hot spasm.
- •History of epilepsy within first-degree relatives.
- •History of head injuries.
- •History of metal in the head (outside the mouth space).
- •History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
- •History of migraines.
- •History of hearing loss (not due to aging) or cochlear implants.
- •History of drug or alcohol abuse during the last year.
- •Women - Pregnancy or not using a reliable method of birth control.
- •Inability to achieve satisfying level of communication with the subject.
- •suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
- •Custodians.
- •Participation in another medical study during the experiment.
结局指标
主要结局
SANS
时间窗: 1.5 year
次要结局
- SOFAS(1.5 Year)