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Effects of Home-Based Transcranial Direct Current Stimulation on Appetite

7 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Active Home-Based 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.
Sham-vergelijker: 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.
Apparaat: Sham Home-Based 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Appetite Visual Analog Scale Score Before and After Stimulation
Tijdsspanne: 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.
Immediately before and after the first stimulation session on Days 7, 14, 21, and 28.
Change in Bedtime Appetite Visual Analog Scale Score Over 4 Weeks
Tijdsspanne: 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.
Daily from Day 1 through Day 28

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Body Weight
Tijdsspanne: Baseline to Week 4
Change in body weight measured in kilograms (kg) from baseline to Week 4.
Baseline to Week 4
Change in Body Mass Index
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Body Fat Percentage
Tijdsspanne: Baseline to Week 4
Change in body fat percentage, measured as a percentage (%), from baseline to Week 4.
Baseline to Week 4
Change in Waist Circumference
Tijdsspanne: Baseline to Week 4
Change in waist circumference measured in centimeters (cm) from baseline to Week 4.
Baseline to Week 4
Change in Skeletal Muscle Mass
Tijdsspanne: Baseline to Week 4
Change in skeletal muscle mass measured in kilograms (kg) using bioelectrical impedance analysis from baseline to Week 4.
Baseline to Week 4
Change in Dutch Eating Behavior Questionnaire Scores
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Reward-Based Eating Drive Scale Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in General Food Cravings Questionnaire-Trait Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
General Food Cravings Questionnaire-State Score
Tijdsspanne: Days 7, 14, 21, and 28
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.
Days 7, 14, 21, and 28
Change in Behavioral Inhibition System Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Behavioral Activation System Scores
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Eating Expectancy Inventory (EEI) Scores
Tijdsspanne: Baseline and Week 4
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.
Baseline and Week 4
Change in Anticipated Negative Effects of Junk Food Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Anticipated Positive Effects of Junk Food Score
Tijdsspanne: 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 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.
Baseline to Week 4
Change in Anticipated Negative Effects of Healthy Food Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Anticipated Positive Effects of Healthy Food Score
Tijdsspanne: 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.
Baseline to Week 4
Change in Perceived Stress Scale Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Pittsburgh Sleep Quality Index Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Beck Depression Inventory-II Score
Tijdsspanne: Baseline to Week 4
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.
Baseline to Week 4
Change in Beck Anxiety Inventory Score
Tijdsspanne: 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.
Baseline to Week 4
Change in Binge Eating Scale Score
Tijdsspanne: Screening to Week 4
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.
Screening to Week 4

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Daily Energy Intake
Tijdsspanne: Daily from Day 1 through Day 28
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.
Daily from Day 1 through Day 28
Daily Carbohydrate Intake
Tijdsspanne: Daily from Day 1 through Day 28
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.
Daily from Day 1 through Day 28
Daily Protein Intake
Tijdsspanne: 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.
Daily from Day 1 through Day 28
Daily Fat Intake
Tijdsspanne: Daily from Day 1 through Day 28
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.
Daily from Day 1 through Day 28
Daily Sugar Intake
Tijdsspanne: Daily from Day 1 through Day 28
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.
Daily from Day 1 through Day 28
Daily Saturated Fat Intake
Tijdsspanne: Daily from Day 1 through Day 28
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.
Daily from Day 1 through Day 28
Daily Dietary Fiber Intake
Tijdsspanne: Daily from Day 1 through Day 28
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.
Daily from Day 1 through Day 28

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seoul National University Hospital

Onderzoekers

  • Hoofdonderzoeker: Hyung jin Choi, MD-PhD, Seoul National University College of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 augustus 2026

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

30 april 2027

Studieregistratiedata

Eerst ingediend

3 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 augustus 2026

Eerst geplaatst (Werkelijk)

11 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

7 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DCS26-SNU

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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).

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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