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临床试验/NCT07406503
NCT07406503已完成不适用

Modulation of the Stressed Brain: Effects of Transcranial Direct Current Stimulation on Stress Regulation and Episodic Future Thinking - an MRI Study in Healthy Volunteers

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Specificity score of episodic future thinking

研究概览

简要总结

This academic study investigates how MRI-compatible transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) influences stress regulation and episodic future thinking in healthy volunteers. Participants undergo one MRI session: combining stress induction, tDCS (real or sham), and functional and metabolic MRI measurements. The study aims to better understand how non-invasive brain stimulation affects the neurophysiological and psychological mechanisms involved in stress processing and future-oriented thinking.

详细描述

The purpose of this study is to examine the modulatory effects of non-invasive brain stimulation on cognitive and emotional processes related to stress regulation and episodic future thinking (EFT).

Healthy adult volunteers complete one MRI session. Participants were randomly assigned to active or sham stimulation. First, participants performed an fMRI-based baseline measurement of the EFT task. This task involves imagining specific future personal events in response to cue words presented on a screen and later verbally describing these imagined events outside the scanner.

During the second part, participants complete the Montreal Imaging Stress Task (MIST) - a mental arithmetic paradigm with time pressure and negative feedback to induce acute stress. Immediately afterward, they receive MRI-compatible tDCS (active or sham) for 20 minutes while at rest. The active tDCS delivers 2 mA current through a 4×4 cm anode placed over the left DLPFC and a cathode over the contralateral orbitofrontal region. Sham stimulation follows the same setup with current ramping only at the onset and offset.

Following stimulation, an ASL perfusion scan, MRS spectroscopy targeting the hippocampus, and a post-stimulation EFT fMRI task were conducted. Throughout the MRI scan, behavioral and psychometric data were collected, including questionnaires on rumination, personality, and mood, as well as physiological and biochemical measures such as salivary cortisol and heart rate variability (HRV).

The primary goal is to assess whether active tDCS modulates the neural, endocrine, and behavioral correlates of stress and future-oriented cognition compared to sham stimulation.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 18-30 years.
  • Right-handed, healthy volunteers.
  • Native Dutch speakers with normal or corrected vision.
  • No current or past psychiatric or neurological disorder.
  • MRI-compatible (no metal implants, pacemaker, etc.).
  • Not taking psychotropic medication.
  • Provided written informed consent.

排除标准

  • Pregnancy.
  • History of epilepsy or neurosurgery.
  • Cardiovascular, neurological, or severe medical illness.
  • Claustrophobia or intolerance to MRI environment.
  • Tattoos or piercings that cannot be removed.
  • Alcohol or caffeine consumption within the restricted window before scanning.
  • Current use of psychoactive substances or psychotropic drugs.

研究组 & 干预措施

Active Transcranial direct current stimulation

Active Comparator

Participants receive MRI-compatible transcranial direct current stimulation (tDCS) using a constant current of 2 mA applied for 20 minutes. The anodal electrode (4 × 4 cm) is positioned over the left dorsolateral prefrontal cortex (F3 position, neuronavigated) and the cathodal electrode over the contralateral orbitofrontal region. Stimulation is delivered while participants are in the MRI scanner.

干预措施: tDCS - Active non-invasive brain stimulation (Device)

Sham Transcranial direct current stimulation

Placebo Comparator

Participants receive sham MRI-compatible transcranial direct current stimulation using the same electrode placement and setup as the active condition. The current is ramped up and down for approximately 30 seconds at the beginning of the session to mimic the initial sensation of stimulation, after which no current is delivered for the remainder of the 20-minute session. Stimulation is administered while participants are in the MRI scanner.

干预措施: tDCS - Sham non-invasive brain stimulation (Device)

结局指标

主要结局

Specificity score of episodic future thinking

时间窗: Baseline and immediately post-tDCS (single study visit)

Specificity of episodic future thinking responses assessed using a standardized scoring procedure applied to imagined future events. Unit of Measure: EFT specificity score (units on a standardized scale)

Momentary mood ratings - fatigue

时间窗: Baseline; immediately post-tDCS; and immediately post-EFT paradigm (single study visit)

Self-reported tension measured using a visual analogue scale (VAS) Unit of Measure:Score on a 0-10 scale. A higher score means more fatigued.

Mean BOLD signal change during episodic future thinking

时间窗: Baseline and immediately post-tDCS (single study visit)

Mean blood-oxygen-level-dependent (BOLD) signal change during the episodic future thinking task, averaged across predefined prefrontal-limbic regions of interest. Unit of Measure: Percent signal change (or beta coefficients from the general linear model)

Momentary mood ratings -tension

时间窗: Baseline; immediately post-tDCS; and immediately post-EFT paradigm (single study visit)

Self-reported tension measured using a visual analogue scale (VAS) Unit of Measure: Score on a 0-10 scale. A higher score means more tensed.

Momentary mood ratings - vigor

时间窗: Baseline; immediately post-tDCS; and immediately post-EFT paradigm (single study visit)

Self-reported vigor measured using a visual analogue scale (VAS). Unit of Measure: Score on a 0-10 scale. A higher score means more vigor.

Momentary mood ratings - anger

时间窗: Baseline; immediately post-tDCS; and immediately post-EFT paradigm (single study visit)

Self-reported anger measured using a visual analogue scale (VAS). Unit of Measure: Score on a 0-10 scale. A higher score means more anger.

Momentary mood ratings - depressed mood

时间窗: Baseline; immediately post-tDCS; and immediately post-EFT paradigm (single study visit)

Self-reported depressed mood measured using a visual analogue scale (VAS). Unit of Measure: Score on a 0-10 scale. A higher score means more depressed mood.

Momentary mood ratings - cheerfulness

时间窗: Baseline; immediately post-tDCS; and immediately post-EFT paradigm (single study visit)

Self-reported cheerfulness measured using a visual analogue scale (VAS). Unit of Measure: Score on a 0-10 scale. A higher score means more cheerfulness.

Momentary mood ratings - stress

时间窗: Baseline; immediately post-tDCS; and immediately post-EFT paradigm (single study visit)

Self-reported stress measured using a visual analogue scale (VAS). Unit of Measure: Score on a 0-10 scale. A higher score means more stress.

Hippocampal glutamate concentration

时间窗: Baseline and immediately post-tDCS (single study visit)

Hippocampal glutamate concentration measured using proton magnetic resonance spectroscopy (¹H-MRS). Unit of Measure: Institutional units

Hippocampal GABA concentration

时间窗: Baseline and immediately post-tDCS (single study visit)

Hippocampal gamma-aminobutyric acid (GABA) concentration measured using proton magnetic resonance spectroscopy (¹H-MRS). Unit of Measure: Institutional units

Hippocampal glutamine concentration

时间窗: Baseline and immediately post-tDCS (single study visit)

Hippocampal glutamine concentration measured using proton magnetic resonance spectroscopy (¹H-MRS).

Hippocampal N-acetylaspartate (NAA) concentration

时间窗: Baseline and immediately post-tDCS (single study visit)

Hippocampal N-acetylaspartate (NAA) concentration measured using proton magnetic resonance spectroscopy (¹H-MRS). Unit of Measure: Institutional units

次要结局

  • Salivary cortisol concentration(Baseline, immediately post-tDCS, and immediately post-EFT task (single study visit))
  • Cerebral blood flow(Baseline and Periprocedural (during tDCS))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara De Witte

Dr.

Universitair Ziekenhuis Brussel

研究点 (1)

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