None listed
Conditions
Interventions
Medical Device : 1. Electrical stimulation device: Starstim tES. Provides non-invasive transcranial random noise stimulation (tRNS) or sham stimulation. tRNS protocol: 2mA, 100–500Hz, 20 minutes per s
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 20 to 65 years at the time of study registration 2. Individuals with a body mass index (BMI) of 23 or higher (including those classified as obese) 3. No significant weight loss or major lifestyle changes within the past 3 months 4. A score of 20 or higher out of 36 on the six “loss of control” items of the General Food Cravings Questionnaire-Trait (G-FCQ-T) 5. Individuals who can fully understand the study content and provide appropriate responses 6. Individuals who have listened to the explanation of the study's purpose and procedures and have voluntarily agreed to participate
Exclusion criteria
Exclusion criteria: 1. Individuals who are unable to fully understand the study explanation or unable to provide voluntary consent 2. Individuals who have been diagnosed with psychiatric or neurological disorders within the past 3 months or are currently under treatment for such conditions 3. Individuals who have taken or are currently taking medications within the past month that may affect body weight or appetite 4. Individuals who are currently taking medications that may influence eating behaviors or mood disorders within the past month 5. Individuals who are pregnant, breastfeeding, or may become pregnant during the study period 6. Any other individuals who, in the judgment of the investigator, have medical conditions or histories that may make it difficult to complete the study or interpret the results properly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group comparison of the change in hedonic hunger scores, assessed using the Korean version of the Power of Food Scale (PFS-K) | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group comparison of changes in anthropometric measures (excluding body weight), including waist circumference, body fat percentage, skeletal muscle mass, and visceral fat, between Visit 1 and Visit 24;Between-group comparison of changes in psychological questionnaires administered at Visit 1 and Visit 24, including: Korean Obesity-related Quality of Life (KoQoL), Dutch Eating Behavior Questionnaire (DEBQ), Barratt Impulsiveness Scale (BIS–11-R), Yale Food Addiction Scale 2.0 (YFAS 2.0), Body Shape Questionnaire (BSQ-8C), Perceived Stress Scale (PSS), Reward-based Eating Drive scale (RED-13), Eating Attitudes Test (EAT), and General Food Cravings Questionnaire-Trait (G-FCQ-T);Comparison of pre- and post-stimulation appetite Visual Analogue Scale (appetite VAS) scores at each visit to assess both acute and cumulative (chronic) effects of electrical stimulation;Between-group comparison of changes in prefrontal oxygenated hemoglobin concentrations, measured via functional near-infrared spectroscopy (fNIRS) during the real food cue task, between Visit 1 and Visit 24;Analysis of brain response prediction models for closed-loop stimulation, based on changes in prefrontal oxygenation measured via functional near-infrared spectroscopy (fNIRS) before and after electrical stimulation, and during the real food cue task;Comparison of self-reported body measurements (body weight, waist circumference, body fat percentage, skeletal muscle mass, visceral fat) obtained via online follow-up assessments (Visit 25 and Visit 26) with pre-post differences (Visit 1 vs. Visit 24), between groups;Between-group comparison of psychological questionnaire scores obtained via online follow-up assessments (Visit 25 and Visit 26), including: Korean Obesity-related Quality of Life (KoQoL), Dutch Eating Behavior Questionnaire (DEBQ), Barratt Impulsiveness Scale (BIS–11-R), Yale Food Addiction Scale 2.0 (YFAS 2.0), Body Shape Questionnaire (BSQ-8C), Perceived Stress Scale (PSS), Reward-based E | — |
Countries
Korea, Republic of
Contacts
Public Contactseolha Lee
Seoul National University
Outcome results
None listed