High-frequency Repetitive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia: The Double-blind Sham-controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The main purpose of this study is to determine whether intensive repetitive transcranial magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in schizophrenia patients and whether it has a positive influence on their cognitive functions, social functions, quality of life, alpha frequency and cortical silent period changes. Also, this study should provide data about safety and tolerability this I-rTMS treatment in schizophrenia patients.
详细描述
Patients undergo 5x EEG from safety and research reasons during the study. Stimulation coil location (left DLPFC) is determined by magnetic resonance imaging (1,5T, 3D- TFE, voxel size 1 x 1 x 1 mm, Intera MR scanner) and stereotactic neuronavigation (Brainsight Frameless).
Patients are evaluated by several psychiatric scales. Positive and negative symptom scale (PANSS) is applied before the first stimulation, at the end of every stimulation day and two weeks after the last stimulation (a total 6). Other psychiatric evaluations used are Clinical global impression (CGI), Sheehan disability scale (SDS), Personal and social performance scale (PSP) and Montgomery-Asberg Depression Scale (MADRS), Calgary depression scale for schizophrenia (CDSS); (MADRS and CDSS are for the exclusion of depression). These scales were used only before the start of the first stimulation, after its completion and two weeks after the last test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Signed an informed consent, the patient must be able and willing to participate in a research study,
- •Undergo an examination by international neuropsychiatric questionnaire MINI - PLUS to confirm the diagnosis of schizophrenia
- •schizophrenic illness duration longer than one year,
- •have a stable and consistent drug treatment at least two weeks prior the rTMS treatment
- •persistent negative symptoms without further psychiatric comorbidity (like depression, mania, anxiety disorders, personality disorders, etc.) in the foreground of the illness
- •The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher and at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms),
- •improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
排除标准
- •involuntary stay in a psychiatric clinic during the recruitment of patients;
- •clinically relevant unstable medical conditions;
- •factors incompatible with the use of rTMS, such as pacemakers, heart pumps and other metal implants;
- •history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG
- •current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines (10mg/D or less of diazepam or equivalent dosage of other benzodiazepines);
- •lack of cognitive skills for participation;
- •clinically relevant psychiatric comorbidity (any other axis 1 diagnosis) detected using MINI Plus, including the current abuse of drugs and alcohol;
- •heart attack or traumatic head injury in the anamnesis
- •Patient unable to undergo a brain MRI
- •Acute risk of suicide;
- •knowledge of Czech language at a level that does not allow fill the required test battery;
- •pregnancy
研究组 & 干预措施
Transcranial Magnetic Stimulation
Active Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)
干预措施: Transcranial Magnetic Stimulation (Device)
Transcranial Magnetic Stimulation with sham coil
Sham coil Treatment 10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC)
干预措施: Transcranial Magnetic Stimulation with sham coil (Device)
结局指标
主要结局
Change from baseline in negative symptoms measured by Negative scale in Positive and Negative Syndrome Scale (PANSS)
时间窗: Baseline, Week 3
次要结局
- Number of Participants with Serious and Non-Serious Adverse Events(Up to 5 weeks)
研究者
Tomáš Svěrák
Mgr.
Masaryk University