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Effects of Home-Based Transcranial Direct Current Stimulation on Appetite

7 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Hyun young Noh, MD
  • Número de telefone: +82 1048507697
  • E-mail: nhy9175@gmail.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.
Comparador Falso: 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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Appetite Visual Analog Scale Score Before and After Stimulation
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Body Weight
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Daily Energy Intake
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Seoul National University Hospital

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de agosto de 2026

Conclusão Primária (Estimado)

31 de março de 2027

Conclusão do estudo (Estimado)

30 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

3 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de agosto de 2026

Primeira postagem (Real)

11 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DCS26-SNU

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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).

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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