Magnetoencephalographic (MEG) Correlates of Negative Symptoms in Patients Suffering From Schizophrenia and Their Influence by Add-on Treatments
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary outcome measures will include continuous and ERP (Event Related Potential) MEG (Magnetoencephalograph) data
研究概览
简要总结
The objective of the suggested study is to identify changes in MEG correlates caused by the add-on treatment with the changes in negative symptoms of schizophrenia by comparing the change in the MEG correlates of the subjects before and during usage of new add on treatments for negative symptoms.
The investigators hypothesize that the gravity of negative symptoms will correlate with a trend towards more aberrant electroencephalographic correlates mainly in continuous parameters, with an emphasis on alpha and delta bands
详细描述
There is a paucity of information regarding electrophysiological correlates of negative symptoms in patients suffering from schizophrenia. The proposed study is set out to compare the MEG correlates of negative symptoms in patients suffering from schizophrenia to those of healthy controls in terms of both relevant ERP components and quantified (continuous) MEG.
The presented study will include two parts: Part A will explore the electrophisological correlates of negative symptoms in patients suffering from schizophrenia using MEG. The study will do so by comparing the electrophisological correlates of schizophrenia patients suffering from negative symptoms and stable on psychiatric treatment to those of healthy controls. In the second part of the study data from part A of patients that have started new add-on treatments for negative symptoms will be compared to parallel data acquired after stabilization on the new treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Study Group (Schizophrenia Patients) Inclusion Criteria
- •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 21 and positive symptom less than
- •Gave informed consent for participation in the study.
- •Stable on the same antipsychotic medication for at least a month prior to entering the study Control Group (healthy Subjects)
- •Inclusion criteria:
- •Healthy man and woman
- •Ages 18-65
- •Right handed
排除标准
- •Study Group (Schizophrenia Patients) (To prevent MEG artifacts by non relevant electric interference or brain conditions)
- •History of epilepsy, seizure, or hot spasm, sever 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 drug or alcohol abuse during the last year. Inability to achieve satisfying level of communication with the subject Control Group (healthy Subjects)
- •History of psychiatric diagnosis
- •Drug or alcohol addiction in the year prior to the study
- •History of epilepsy, seizure, or hot spasm.
- •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.
- •Use of psychotropic medication
结局指标
主要结局
Primary outcome measures will include continuous and ERP (Event Related Potential) MEG (Magnetoencephalograph) data
时间窗: four months
次要结局
未报告次要终点