Neurophysiological Effects of Transcranial Direct Current Stimulation on Appetite: Randomized, Placebo-Controlled, Double-Blind, Parallel-Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in Appetite Visual Analog Scale Score Before and After Stimulation
研究概览
简要总结
This randomized, placebo-controlled, double-blind, parallel-design study aims to evaluate the neurophysiological effects of home-based transcranial direct current stimulation (tDCS) on appetite in adults with binge eating tendencies.
Participants will be randomly assigned to either an active tDCS group or a sham stimulation group. After baseline assessments, participants will self-administer home-based tDCS twice daily for 4 weeks using a wearable wellness device. Appetite, eating behavior, body composition, dietary intake, and psychological outcomes will be assessed throughout the study to evaluate both the acute and chronic effects of repeated tDCS.
详细描述
Obesity and binge eating behaviors are closely associated with abnormal appetite regulation and food craving. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that may modulate prefrontal cortical activity involved in appetite control and inhibitory regulation.
The objective of this study is to investigate whether repeated home-based tDCS reduces appetite and improves eating-related behaviors in adults with binge eating tendencies.
This study is a randomized, placebo-controlled, double-blind, parallel-design trial. A total of 100 participants aged 19 to 65 years with Binge Eating Scale (BES) scores of 18 or higher will be enrolled and randomized in a 1:1 ratio to either an active tDCS group or a sham stimulation group.
Participants will perform home-based tDCS twice daily for 4 weeks using a wearable wellness scalp stimulation device. Appetite will be evaluated using repeated visual analogue scale (VAS) assessments to examine both acute and chronic effects of stimulation. Secondary outcome measures include changes in body composition, eating behavior questionnaires, food craving, binge eating severity, dietary intake, sleep quality, stress, depression, and anxiety.
The findings of this study are expected to provide evidence regarding the neurophysiological effects of repeated home-based tDCS on appetite regulation and eating behavior.
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)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 19 to 65 years
- •Binge Eating Scale (BES) score ≥18
- •BMI ≥18.5 kg/m²
- •No significant weight loss or lifestyle changes during the previous 3 months
- •Stable chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) are allowed
- •Able to use an Android smartphone compatible with the study application (including a study phone if provided)
- •Able and willing to provide written informed consent
排除标准
- •Unable to understand the study procedures or provide informed consent
- •Implanted pacemaker, implantable cardioverter-defibrillator, deep brain stimulator, cochlear implant, coronary stent, or other implanted metallic medical devices (dental implants and joint prostheses are allowed)
- •Diagnosis or treatment for a psychiatric or neurological disorder within the previous 3 months
- •Use of medications affecting appetite or body weight within the previous month
- •Use of medications affecting eating behavior or mood within the previous month
- •Pregnant or breastfeeding
- •Any medical condition judged by the investigator to interfere with study participation or interpretation of study results
研究组 & 干预措施
Active tDCS
Participants receive active home-based transcranial direct current stimulation (tDCS) using a wearable wellness scalp stimulation device. Active stimulation delivers 1.0 mA direct current for 20 minutes twice daily for 4 weeks.
干预措施: Active Home-Based tDCS (Device)
Sham tDCS
Participants receive sham home-based transcranial direct current stimulation (tDCS) using the same wearable wellness scalp stimulation device. Sham stimulation delivers brief current only at the beginning and end of each session to maintain blinding.
干预措施: Sham Home-Based tDCS (Device)
结局指标
主要结局
Change in Appetite Visual Analog Scale Score Before and After Stimulation
时间窗: Immediately before and after the first stimulation session on Days 7, 14, 21, and 28.
Acute change in appetite is assessed using the Appetite Visual Analog Scale (VAS) immediately before and after the first daily stimulation session on Days 7, 14, 21, and 28. The acute effect is defined as the change in Appetite VAS score from immediately before to immediately after stimulation. The Appetite Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater appetite.
Change in Bedtime Appetite Visual Analog Scale Score Over 4 Weeks
时间窗: Daily from Day 1 through Day 28
Chronic change in appetite is assessed using the bedtime Appetite Visual Analog Scale (BT-VAS), measured once daily before bedtime from Day 1 through Day 28. The chronic effect is evaluated based on the change in bedtime Appetite VAS scores over time during the 4-week intervention period. The Appetite Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater appetite.
次要结局
- Change in Body Weight(Baseline to Week 4)
- Change in Body Mass Index(Baseline to Week 4)
- Change in Body Fat Percentage(Baseline to Week 4)
- Change in Waist Circumference(Baseline to Week 4)
- Change in Skeletal Muscle Mass(Baseline to Week 4)
- Change in Dutch Eating Behavior Questionnaire Scores(Baseline to Week 4)
- Change in Reward-Based Eating Drive Scale Score(Baseline to Week 4)
- Change in General Food Cravings Questionnaire-Trait Score(Baseline to Week 4)
- General Food Cravings Questionnaire-State Score(Days 7, 14, 21, and 28)
- Change in Behavioral Inhibition System Score(Baseline to Week 4)
- Change in Behavioral Activation System Scores(Baseline to Week 4)
- Change in Eating Expectancy Inventory (EEI) Scores(Baseline and Week 4)
- Change in Anticipated Negative Effects of Junk Food Score(Baseline to Week 4)
- Change in Anticipated Positive Effects of Junk Food Score(Baseline to Week 4)
- Change in Anticipated Negative Effects of Healthy Food Score(Baseline to Week 4)
- Change in Anticipated Positive Effects of Healthy Food Score(Baseline to Week 4)
- Change in Perceived Stress Scale Score(Baseline to Week 4)
- Change in Pittsburgh Sleep Quality Index Score(Baseline to Week 4)
- Change in Beck Depression Inventory-II Score(Baseline to Week 4)
- Change in Beck Anxiety Inventory Score(Baseline to Week 4)
- Change in Binge Eating Scale Score(Screening to Week 4)
研究者
Hyung Jin Choi
Professor, Department of Brain and Cognitive Sciences, Seoul National University College of Medicine
Seoul National University Hospital