Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms: a Double-blind, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale, Negative subscore
研究概览
简要总结
The major target of the study is to confirm the safety and efficacy of our augmented protocol of theta-burst TMS in schizophrenia. Our aim is to confirm the beneficial effects of rTMS treatment on multiple aspects of the disorder such as (1) clinical aspect in terms of PANSS, (2) cognitive aspect such as emotion recognition (ER) and working memory (WM) / distractor filtering (DF) performance, and (3) neurobiology in terms of electrophysiology correlates of ER, WM and DF such as event related theta synchronization, resting state theta power, and network connectivity. Response prediction to (theta-burst) TB-rTMS will be the exploratory part of the study.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of schizophrenia or schizoaffective disorder;
- •clinically stabilized on antipsychotic: a stable dose of antipsychotic medication for >4 weeks;
- •age 18-55 years, and
- •presence of negative symptoms (based on PANSS): a negative subscore ≥16 points and [one of items N1-N7 scoring ≥4 or two items N1-N7 scoring ≥3]
排除标准
- •any significant neurological illness;
- •mental retardation
- •history of head injury with loss of consciousness for more than 1 hour
- •history of epileptic seizures or epileptic activity on the baseline EEG (evaluated by an expert in clinical EEG and epilepsy),
- •alcohol or drug abuse within the past 3 months, and
- •depressive episode or antidepressant treatment in the past 4 weeks.
- •Severe positive symptoms inferfere with cognitive tests
- •ECT in the medical history
- •Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device
- •Skin surface is severly injured in the stimulated region of the skull
- •Sclerosis multiplex
- •Severe sleep deprivation
- •Severe heart failure
- •Increased intracranial pressure
- •Untreated migrain
研究组 & 干预措施
Theta-burst rTMS
Theta-burst repetitive transcranial magnetic stimulation
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham stimulation
Sham stimulation of the same location
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
Positive and Negative Syndrome Scale, Negative subscore
时间窗: 4 weeks
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. It is the gold standard in the treatment monitoring of schizophrenia.The scale has three subscales : positive, negatve and general symptom score. We use the negative subscore as primary outcome. Its minimum and maximum scores are 7 and 49 respectively. Higher values indicate worse outcome.
次要结局
- Cognitive functioning/Short-Term Memory - The Digit Span Forward and Backward tests(4 weeks)
- Cognitive functioning/Executive functioning - Wisconsin Card Sorting test(4 weeks)
- Social cognition 1 - The Baron-Cohen 'Reading the Mind in the Eyes Test '(4 weeks)
- Social cognition 2 - The 'Faux Pas' test.(4 weeks)
- Facial Emotion Recogniton - Karolinska Directed Emotional Face set(4 weeks)
- Safety in terms of adverse events(4 weeks)
研究者
Gábor Csukly
Assistant Professor
Semmelweis University