Exploring the Role of the Prefrontal Cortex in Decision-Making
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Blood-oxygen-level-dependent (BOLD) signal changes during task-based functional magnetic resonance imaging (fMRI)
研究概览
简要总结
The goal of this study is to examine whether high-definition transcranial direct current stimulation (HD-tDCS) can influence decision-making for emotionally valenced content in younger and older adults, with or without major depression.
The main questions are:
In healthy adults, does brain stimulation modulate how people respond to emotionally valenced content during a decision-making task? What happens in the brain during modulation? Do these effects differ between younger and older adults?
In adults with depression, does brain stimulation help shift attention towards positive content during the task? What happens in the brain? Are these effects moderated by age (younger vs. older adults)?
The investigators will compare participants who receive real stimulation to those who receive sham (placebo) stimulation.
Participants will:
Receive high-definition transcranial direct current stimulation (HD-tDCS) of the dorsolateral prefrontal cortex (DLPFC)
Perform a decision-making task involving emotionally valenced words
Complete the task while undergoing a brain scan using ultra-high field 7 Tesla magnetic resonance imaging (MRI) to measure brain activity
详细描述
This study investigates whether non-invasive brain stimulation influences decision-making in four groups: younger adults (20-40 years) and older adults (60-75 years), healthy or with mild to moderate major depression. Participants with personality disorders or psychosis will be excluded.
The study builds on evidence that the dorsolateral prefrontal cortex (DLPFC) plays a key role in evaluating emotionally-valenced material and decision-making. The investigators will examine whether modulation of this region through high-definition transcranial direct current stimulation (HD-tDCS) affects responses to emotionally valenced information. Stimulation will be administered differently across groups based on theoretical models of hemispheric function in mood regulation.
To explore the effect of stimulation at neurotransmitter level, the investigators will use ultra-high field 7 Tesla magnetic resonance spectroscopy (MRS) to measure Gamma-aminobutyric acid (GABA) / Glutamate concentrations in regions of interest at baseline and after stimulation. This allows to examine whether changes in inhibitory/excitatory neurotransmitters are linked to altered emotional processing and decision making.
By combining brain stimulation, ultra-high field neuroimaging, and spectroscopy, this study examines how changes in brain network activity and neurotransmitter levels relate to decision-making in health and disease. The inclusion of both younger and older adults allows the investigators to explore age-related differences in these processes.
This project aims to provide mechanistic insights into decision-making in health and disease and to support the development of targeted neuromodulation therapies that could modulate emotional processing.
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
- Double (Participant, Investigator)
盲法说明
Participants and experimentors are blinded to the intervention. The principal investigator managing randomization and code assignment is unblinded. Outcomes assessors remain blinded during data collection but will be unblinded after data collection is completed for final analysis.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent
- •Age between 20-40 or 60-75 years
- •Fluent in German
- •Normal or corrected-to-normal vision
- •No color blindness
- •Right-handed
- •Non-smoker
排除标准
- •History of neurological disorders
- •History of psychiatric disorders
- •Use of psychotropic medication
- •Presence of magnetizable implants
- •Alcohol or drug dependence
- •Inclusion Criteria (Patient):
- •Written Informed Consent
- •Diagnosed with mild to moderate depression
- •Age between 20-40 or 60-75 years
- •Fluent in German
- •Normal or corrected-to-normal vision
- •No color blindness
- •Exclusion Criteria (Patient):
- •Intake of benzodiazepines or antipsychotic medication
- •psychiatric disorders other than depression (e.g., psychosis, mania, personality disorders) or depression with organic cause
- •Presence of magnetizable implants
- •Alcohol or drug dependence
研究组 & 干预措施
Active Stimulation (Healthy)
Healthy adults aged 20 to 40 or 60 to 75 years.
干预措施: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 (Device)
Sham Stimulation (Healthy)
Healthy adults aged 20 to 40 or 60 to 75 years.
干预措施: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/F4 (Device)
Active Stimulation (Patient)
Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years.
干预措施: Active high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4 (Device)
Sham Stimulation (Patient)
Patients with mild to moderate depression aged 20 to 40 or 60 to 75 years.
干预措施: Sham high-definition transcranial direct current stimulation (HD-tDCS) - anodal F3/ kathodal F4 (Device)
结局指标
主要结局
Blood-oxygen-level-dependent (BOLD) signal changes during task-based functional magnetic resonance imaging (fMRI)
时间窗: During study visit; measured continuously during the 20-minute stimulation period
Blood-oxygen-level-dependent (BOLD) signal changes will be measured using ultra-high field functional magnetic resonance imaging (fMRI) during a cognitive decision-making task designed to engage prefrontal cortex regions associated with cognitive control and decision making. Structural T1-weighted and T2-weighted images will also be acquired for anatomical localization and normalization. Primary regions of interest (ROIs) include the dorsolateral prefrontal cortex (DLPFC), subgenual anterior cingulate cortex (sgACC), amygdala, and hippocampus.
GABA concentration (baseline)
时间窗: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
Magnetic resonance spectroscopy (MRS) will be used to measure Gamma-aminobutyric acid (GABA) concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
Glutamate concentration (baseline)
时间窗: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
Glutamate concentration (after stimulation)
时间窗: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest after HD-tDCS. The goal is to examine stimulation-related neutransmitter changes.
Blood-oxygen-level-dependent (BOLD) signal changes during task-based functional magnetic resonance imaging (fMRI)
时间窗: During study visit; measured continuously during the 20-minute stimulation period
Blood-oxygen-level-dependent (BOLD) signal changes will be measured using ultra-high field functional magnetic resonance imaging (fMRI) during a cognitive decision-making task designed to engage prefrontal cortex regions associated with cognitive control and decision making. Structural T1-weighted and T2-weighted images will also be acquired for anatomical localization and normalization. Primary regions of interest (ROIs) include the dorsolateral prefrontal cortex (DLPFC), subgenual anterior cingulate cortex (sgACC), amygdala, and hippocampus.
GABA concentration (baseline)
时间窗: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
Magnetic resonance spectroscopy (MRS) will be used to measure Gamma-aminobutyric acid (GABA) concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
GABA concentration (after stimulation)
时间窗: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
Magnetic resonance spectroscopy (MRS) will be used to measure Gamma-aminobutyric acid (GABA) concentrations in regions of interest after HD-tDCS. The goal is to examine stimulation-related neutransmitter changes.
Glutamate concentration (baseline)
时间窗: During study visit; during a 9-minute magnetic resonance spectroscopy (MRS) session performed up to 10 minutes prior to the 20-minute stimulation period
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest at baseline. The goal is to examine stimulation-related neutransmitter changes.
Glutamate concentration (after stimulation)
时间窗: During study visit; within 1 minute after the 20-minute stimulation period, during a 9-minute MRS scan
Magnetic resonance spectroscopy (MRS) will be used to measure Glutamate concentrations in regions of interest after HD-tDCS. The goal is to examine stimulation-related neutransmitter changes.
次要结局
- Positive Affect measured by PANAS (baseline)(During study visit; at baseline, up to two hours before the 20-minute stimulation period)
- Negative Affect measured by PANAS (baseline)(During study visit; at baseline, up to two hours before the 20-minute stimulation period)
- Positive Affect measured by PANAS (after stimulation)(During study visit; after stimulation, up to 1 hour)
- Negative Affect measured by PANAS (after stimulation)(During study visit; after stimulation, up to 1 hour)
- Storytelling (baseline)(During study visit; at baseline, up to two hours before the 20-minute stimulation period)
- Storytelling (after stimulation)(During study visit; after stimulation, up to 1 hour)
- Positive Affect measured by PANAS (baseline)(During study visit; at baseline, up to two hours before the 20-minute stimulation period)
- Negative Affect measured by PANAS (baseline)(During study visit; at baseline, up to two hours before the 20-minute stimulation period)
- Positive Affect measured by PANAS (after stimulation)(During study visit; after stimulation, up to 1 hour)
- Negative Affect measured by PANAS (after stimulation)(During study visit; after stimulation, up to 1 hour)
- Storytelling (baseline)(During study visit; at baseline, up to two hours before the 20-minute stimulation period)
- Storytelling (after stimulation)(During study visit; after stimulation, up to 1 hour)