Effects of Transcranial Direct Current Stimulation on Stress Reactivity and Decision Making in Unaffected Siblings of Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Cortisol
研究概览
简要总结
An exacerbated response to stress mediated by activation of the Hypothalamo-Pituitary-Adrenocortical (HPA) axis is thought to play an important role in the onset, worsening and relapse of schizophrenia. Subjects at risk for schizophrenia (unaffected siblings of patients) displayed an intermediate hyperreactivity to stress as compared with patients and healthy controls.
Symptoms of schizophrenia can be reduced with noninvasive brain stimulation (NIBS) applied over the dorsolateral prefrontal cortex (DLPFC). Importantly, this same DLPFC NIBS protocol can modulate decision making processes and modulate biological reactivity to stress by decreasing salivary cortisol concentration in acute stress condition.
详细描述
The objective of this project is to evaluate how the modulation of DLPFC activity in acute stress condition influences decision-making in unaffected siblings of patients with schizophrenia.
Methods: 30 unaffected siblings of patients with schizophrenia will be enrolled and randomized into 2 groups. 15 subjects will receive active tDCS (2mA, 30 min, anode left DLPFC, cathode right DLPFC) and 15 will receive sham tDCS.
tDCS procedure: There is a total of 30 minutes of stimulation at the intensity of 2mA (ramp up and ramp down: 30 sec). Sham stimulation consists in delivering 1 minute of real stimulation. The stimulation site (DLPFC) will be anatomically determined according to 10/20 EEG system (F3 & F4). This procedure is in accordance with international guidelines for safety. Safety and blinding will be assessed using specific tools at the end of the protocol.
Stress paradigm: In order to induce moderate stress in humans in laboratory condition, the investigators will use the Maastricht Acute Stress Test (MAST). This test is a combination between physical (hand immersion in cold water) and cognitive (arithmetic calculation) stress. Test will start 5 minutes after the beginning of stimulation session.
Decision-making paradigm: The decision-making task will be performed before and after the MAST (during the stimulation) in order to compare changes induce by stress and/or stimulation. The choose test is the Delay Discounting Task (DDT) permitting a measure of decision-making, reward seeking and impulsivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The subject will be blind of the treatment he receives (active or placebo).
- The experimenter will also be blinded from stimulation (active or placebo) Each subject will be assigned a randomization code, corresponding to the code to enter the tDCS device. This system allows the person who administers tDCS and the subject receiving the stimulation to be blind .
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject to genetic risk of schizophrenia, related first-degree schizophrenic patient
- •Man and woman
- •Age between 18 and 30 years old
排除标准
- •Contraindications to the practice of the tDCS, for safety measure, we will use the same contraindications as the practice of the Magnetic resonance imaging
- •Psychiatric disorder on axis I of DSM 5
- •Pregnant or nursing women
研究组 & 干预措施
Transcranial stimulation in direct current(tDCS)active
30 minutes of active Transcranial stimulation in direct current
干预措施: Transcranial stimulation in direct current (Device)
Transcranial stimulation in direct current(tDCS) placebo
30 minutes of placebo stimulation
干预措施: Transcranial stimulation in direct current (Device)
结局指标
主要结局
Cortisol
时间窗: One year
Salivary cortisol will be analyzed, using Salivette tubes
次要结局
- Decision-making capacities(6 mois)
- electroencephalography(6 mois)