NCT07757438

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 3, 2026

Last Update Submit

August 7, 2026

Conditions

AppetiteBinge Eating BehaviourFood Cravings

Keywords

Transcranial Direct Current StimulationtDCSAppetiteFood CravingBinge EatingEating BehaviorHome-based InterventionNeuromodulation

Outcome Measures

Primary Outcomes (2)

  • Change in Appetite Visual Analog Scale Score Before and After Stimulation

    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

    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

Secondary Outcomes (21)

  • 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

  • +16 more secondary outcomes

Other Outcomes (7)

  • Daily Energy Intake

    Daily from Day 1 through Day 28

  • Daily Carbohydrate Intake

    Daily from Day 1 through Day 28

  • Daily Protein Intake

    Daily from Day 1 through Day 28

  • +4 more other outcomes

Study Arms (2)

Active tDCS

EXPERIMENTAL

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.

Device: Active Home-Based tDCS

Sham tDCS

SHAM COMPARATOR

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.

Device: Sham Home-Based tDCS

Interventions

Active Home-Based tDCSDEVICE

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.

Active tDCS
Sham Home-Based tDCSDEVICE

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.

Sham tDCS

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Binge-Eating DisorderBulimiaFeeding Behavior

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Hyung jin Choi, MD-PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun young Noh, MD

CONTACT

+82 1048507697nhy9175@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Brain and Cognitive Sciences, Seoul National University College of Medicine

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 11, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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).