Navigated Alpha Frequency Transcranial Magnetic Stimulation (αTMS) in Treatment-resistant Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on auditory hallucinations as well as negative symptoms of schizophrenia. However, previous studies have reported mixed or negative results. Majority of the repetitive transcranial magnetic stimulation (rTMS) studies to date has set the target of cortical stimulation based on scalp site. Recently introduced method, navigated transcranial magnetic stimulation (nTMS) integrates the individual MRI data, and thus allows more precise targeting on brain cortical regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced alpha band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG guided TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising results.
The aim of the study is to investigate the efficacy of navigated individualized αTMS in treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test battery at baseline, 5 days after and 3 months after treatment. Serum and plasma levels of brain derived neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male righthanded inpatients, 18 to 64 years of age
- •The diagnosis of Schizophrenia or Schizoaffective Disorder according to DSM-IV
- •Capacity and willingness to give informed consent
- •Patient is treatment-resistant, CGI-S 4 or more
- •Patient is not requiring a change in antipsychotic medication 2 weeks prior to or during treatment
- •No foreseeable changes in patient's smoking habits during treatment
排除标准
- •Serious somatic illness
- •Progressive neurological illness, recent brain damage (less than 3 months ago) or sequela of serious brain damage
- •Unstable epilepsy
- •Electro convulsive therapy (ECT) less than 3 months prior to treatment
研究组 & 干预措施
Sham TMS
navigated Transcranial Magnetic Stimulation using sham coil
干预措施: navigated Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: at baseline,5 days after treatment, 3 months after treatment
change in PANSS total, positive, negative and general psychopathology sum score
次要结局
- Clinical Global Impression - Improvement scale (CGI-I)(at 5 days after treatment, 3 months after treatment)
- Neuropsychology test battery(at baseline, 5 days after treatment, 3 months after treatment)
研究者
Heli Tuppurainen
MD, PhD
Niuvanniemi Hospital