Effects of Home-Based Transcranial Direct Current Stimulation on Appetite
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active Home-Based tDCS
DeviceParticipants 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 Home-Based tDCS
DeviceParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately before and after the first stimulation session on Days 7, 14, 21, and 28.2
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.
Time frame
Daily from Day 1 through Day 28Secondary outcomes
1
Change in Body Weight
Change in body weight measured in kilograms (kg) from baseline to Week 4.
Time frame
Baseline to Week 42
Change in Body Mass Index
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.
Time frame
Baseline to Week 43
Change in Body Fat Percentage
Change in body fat percentage, measured as a percentage (%), from baseline to Week 4.
Time frame
Baseline to Week 44
Change in Waist Circumference
Change in waist circumference measured in centimeters (cm) from baseline to Week 4.
Time frame
Baseline to Week 4Other outcomes
1
Daily Energy Intake
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.
Time frame
Daily from Day 1 through Day 282
Daily Carbohydrate Intake
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.
Time frame
Daily from Day 1 through Day 283
Daily Protein Intake
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.
Time frame
Daily from Day 1 through Day 284
Daily Fat Intake
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.
Time frame
Daily from Day 1 through Day 28Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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