Effects of Home-Based Transcranial Direct Current Stimulation on Appetite
perjantai 7. elokuuta 2026 päivittänyt: Hyung Jin Choi, Seoul National University Hospital
Neurophysiological Effects of Transcranial Direct Current Stimulation on Appetite: Randomized, Placebo-Controlled, Double-Blind, Parallel-Design
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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
100
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Hyun young Noh, MD
- Puhelinnumero: +82 1048507697
- Sähköposti: nhy9175@gmail.com
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
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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.
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Huijausvertailija: 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.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Appetite Visual Analog Scale Score Before and After Stimulation
Aikaikkuna: Immediately before and after the first stimulation session on Days 7, 14, 21, and 28.
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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.
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Immediately before and after the first stimulation session on Days 7, 14, 21, and 28.
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Change in Bedtime Appetite Visual Analog Scale Score Over 4 Weeks
Aikaikkuna: Daily from Day 1 through Day 28
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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.
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Daily from Day 1 through Day 28
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Body Weight
Aikaikkuna: Baseline to Week 4
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Change in body weight measured in kilograms (kg) from baseline to Week 4.
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Baseline to Week 4
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Change in Body Mass Index
Aikaikkuna: Baseline to Week 4
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Change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²), from baseline to Week 4.
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Baseline to Week 4
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Change in Body Fat Percentage
Aikaikkuna: Baseline to Week 4
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Change in body fat percentage, measured as a percentage (%), from baseline to Week 4.
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Baseline to Week 4
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Change in Waist Circumference
Aikaikkuna: Baseline to Week 4
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Change in waist circumference measured in centimeters (cm) from baseline to Week 4.
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Baseline to Week 4
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Change in Skeletal Muscle Mass
Aikaikkuna: Baseline to Week 4
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Change in skeletal muscle mass measured in kilograms (kg) using bioelectrical impedance analysis from baseline to Week 4.
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Baseline to Week 4
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Change in Dutch Eating Behavior Questionnaire Scores
Aikaikkuna: Baseline to Week 4
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The Dutch Eating Behavior Questionnaire (DEBQ) assesses restrained, emotional, and external eating behavior using 33 items rated on a 5-point scale.
The restrained eating subscale consists of 10 items, yielding a total score ranging from 10 to 50; higher scores indicate greater dietary restraint and stronger conscious control of food intake.
The emotional eating subscale consists of 13 items, yielding a total score ranging from 13 to 65; higher scores indicate a greater tendency to eat in response to emotional states.
The external eating subscale consists of 10 items, yielding a total score ranging from 10 to 50; higher scores indicate a greater tendency to eat in response to external food-related cues.
Changes in the three DEBQ subscale scores will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Reward-Based Eating Drive Scale Score
Aikaikkuna: Baseline to Week 4
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The Reward-Based Eating Drive Scale-13 (RED-13) assesses reward-based eating, including loss of control over eating, lack of satiety, and preoccupation with food.
The 13 items are rated from 1 to 5 and summed to yield a total score ranging from 10 to 65.
Higher scores indicate greater reward-based eating drive.
Change in RED-13 total score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in General Food Cravings Questionnaire-Trait Score
Aikaikkuna: Baseline to Week 4
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The General Food Cravings Questionnaire-Trait (G-FCQ-T) assesses trait-like general food craving.
It consists of 21 items rated from 1 to 6, yielding a total score ranging from 21 to 126.
Higher scores indicate greater trait food craving.
Change in G-FCQ-T total score will be assessed from baseline to Week 4.
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Baseline to Week 4
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General Food Cravings Questionnaire-State Score
Aikaikkuna: Days 7, 14, 21, and 28
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The General Food Cravings Questionnaire-State (G-FCQ-S) assesses current or momentary food craving.
It consists of 15 items rated on a 5-point scale from 1 to 5, yielding a total score ranging from 15 to 75.
Higher scores indicate greater current food craving.
G-FCQ-S scores will be assessed repeatedly on Days 7, 14, 21, and 28 during the 4-week intervention period.
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Days 7, 14, 21, and 28
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Change in Behavioral Inhibition System Score
Aikaikkuna: Baseline to Week 4
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The Behavioral Inhibition System (BIS) scale consists of 7 items rated on a 4-point scale from 1 to 4, yielding a total score ranging from 7 to 28.
Higher scores indicate greater sensitivity to punishment and stronger behavioral inhibition.
Change in the BIS score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Behavioral Activation System Scores
Aikaikkuna: Baseline to Week 4
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The Behavioral Activation System (BAS) scale consists of 13 items rated on a 4-point scale from 1 to 4 and comprises three subscales: Reward Responsiveness (5 items; score range, 5-20), Drive (4 items; score range, 4-16), and Fun Seeking (4 items; score range, 4-16).
Higher scores indicate greater reward responsiveness, stronger goal-directed drive, and greater fun-seeking tendency, respectively.
Changes in the BAS subscale scores will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Eating Expectancy Inventory (EEI) Scores
Aikaikkuna: Baseline and Week 4
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The Korean version of the Eating Expectancy Inventory (EEI) assesses expectancies regarding the psychological and emotional consequences of eating.
The questionnaire consists of 28 items rated on a 7-point Likert scale from 1 to 7, yielding a total score ranging from 28 to 196.
Higher scores indicate stronger endorsement of eating-related expectancies.
Change in the EEI total score will be assessed from baseline to Week 4.
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Baseline and Week 4
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Change in Anticipated Negative Effects of Junk Food Score
Aikaikkuna: Baseline to Week 4
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The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food.
The negative affect subscale for junk food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72.
Higher scores indicate stronger anticipated negative emotional effects of eating junk food.
Change in the subscale score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Anticipated Positive Effects of Junk Food Score
Aikaikkuna: Baseline to Week 4
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The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food.
The positive affect subscale for junk food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72.
Higher scores indicate stronger anticipated positive emotional effects of eating junk food.
Change in the subscale score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Anticipated Negative Effects of Healthy Food Score
Aikaikkuna: Baseline to Week 4
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The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food.
The negative affect subscale for healthy food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72.
Higher scores indicate stronger anticipated negative emotional effects of eating healthy food.
Change in the subscale score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Anticipated Positive Effects of Healthy Food Score
Aikaikkuna: Baseline to Week 4
|
The Korean version of the Anticipated Effects of Food Scale (AEFS) assesses anticipated emotional responses to eating food.
The positive affect subscale for healthy food consists of 12 items rated from 1 to 6, yielding a total score ranging from 12 to 72.
Higher scores indicate stronger anticipated positive emotional effects of eating healthy food.
Change in the subscale score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Perceived Stress Scale Score
Aikaikkuna: Baseline to Week 4
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The Perceived Stress Scale (PSS) assesses the degree to which situations in one's life are perceived as stressful.
For the 10-item version (PSS-10), items are scored from 0 to 4 and summed after reverse scoring the positively stated items, yielding a total score ranging from 0 to 40.
Higher scores indicate greater perceived stress.
Change in PSS total score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Pittsburgh Sleep Quality Index Score
Aikaikkuna: Baseline to Week 4
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The Pittsburgh Sleep Quality Index (PSQI) assesses subjective sleep quality and disturbances.
Seven component scores are summed to yield a global score ranging from 0 to 21.
Higher scores indicate poorer sleep quality and greater sleep disturbance.
Change in PSQI global score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Beck Depression Inventory-II Score
Aikaikkuna: Baseline to Week 4
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The Beck Depression Inventory-II (BDI-II) assesses the severity of depressive symptoms.
The 21 items are scored from 0 to 3 and summed to yield a total score ranging from 0 to 63.
Higher scores indicate greater severity of depressive symptoms.
Change in BDI-II total score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Beck Anxiety Inventory Score
Aikaikkuna: Baseline to Week 4
|
The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms.
The 21 items are scored from 0 to 3 and summed to yield a total score ranging from 0 to 63.
Higher scores indicate greater severity of anxiety symptoms.
Change in BAI total score will be assessed from baseline to Week 4.
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Baseline to Week 4
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Change in Binge Eating Scale Score
Aikaikkuna: Screening to Week 4
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The Binge Eating Scale (BES) assesses the severity of binge eating symptoms and associated thoughts and behaviors.
The scale consists of 16 items, with item responses assigned weighted scores ranging from 0 to 3. The total score ranges from 0 to 46, with higher scores indicating greater severity of binge eating symptoms.
Change in the BES total score will be assessed from screening to Week 4.
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Screening to Week 4
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Daily Energy Intake
Aikaikkuna: Daily from Day 1 through Day 28
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Daily total energy intake, measured in kilocalories per day (kcal/day), will be assessed using dietary records entered in the FatSecret mobile application throughout the 4-week intervention period.
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Daily from Day 1 through Day 28
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Daily Carbohydrate Intake
Aikaikkuna: Daily from Day 1 through Day 28
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Daily carbohydrate intake, measured in grams per day (g/day), will be assessed using dietary records entered in the FatSecret mobile application throughout the 4-week intervention period.
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Daily from Day 1 through Day 28
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Daily Protein Intake
Aikaikkuna: Daily from Day 1 through Day 28
|
Daily protein intake, measured in grams per day (g/day), will be assessed using dietary records entered in the FatSecret mobile application throughout the 4-week intervention period.
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Daily from Day 1 through Day 28
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Daily Fat Intake
Aikaikkuna: Daily from Day 1 through Day 28
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Daily total fat intake, measured in grams per day (g/day), will be assessed using dietary records entered in the FatSecret mobile application throughout the 4-week intervention period.
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Daily from Day 1 through Day 28
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Daily Sugar Intake
Aikaikkuna: Daily from Day 1 through Day 28
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Daily total sugar intake, measured in grams per day (g/day), will be assessed using dietary records entered in the FatSecret mobile application throughout the 4-week intervention period.
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Daily from Day 1 through Day 28
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Daily Saturated Fat Intake
Aikaikkuna: Daily from Day 1 through Day 28
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Daily saturated fat intake, measured in grams per day (g/day), will be assessed using dietary records entered in the FatSecret mobile application throughout the 4-week intervention period.
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Daily from Day 1 through Day 28
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Daily Dietary Fiber Intake
Aikaikkuna: Daily from Day 1 through Day 28
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Daily dietary fiber intake, measured in grams per day (g/day), will be assessed using dietary records entered in the FatSecret mobile application throughout the 4-week intervention period.
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Daily from Day 1 through Day 28
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Hyung jin Choi, MD-PhD, Seoul National University College of Medicine
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Lauantai 15. elokuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Keskiviikko 31. maaliskuuta 2027
Opintojen valmistuminen (Arvioitu)
Perjantai 30. huhtikuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 3. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 7. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Tiistai 11. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 11. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 7. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DCS26-SNU
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
Individual participant data (IPD) will not be shared because there is no current plan for public or external data sharing.
De-identified study data will be used only for the purposes described in the study protocol and approved by the Institutional Review Board (IRB).
Lääke- ja laitetiedot, tutkimusasiakirjat
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Ei
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Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .