Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields
Phase: NA
Conditions: Depression
Sponsor: Yonsei University

2023.03.23
1
NCT No. : NCT05539131
Date of Creation: March 23, 2023
Study Title: 
Demonstration Study of the 
Effect of Transcranial Direct 
Current Stimulation (tDCS) 
for Patients with Depression 
in Clinical Fields

2023.03.23
2
Study Protocol with Statistical Analysis Plan (SAP)
Study Title: Demonstration Study of the Effect of Transcranial Direct Current 
Stimulation (tDCS) for Patients with Depression in Clinical Fields
Study Protocol
Purpose
1.
Demonstrate the clinical effectiveness of transcranial direct current stimulation (tDCS) 
for patients with depression in real-world clinical settings.
2.
Optimize home-based electroceutical technologies for patient-centered applications.
3.
Generate real-world data (RWD) and evidence (RWE) to support the adoption of 
tDCS in clinical practice.
Design
1.
Overview:
○
Randomized, double-blinded, multi-site clinical study.
○
Participants: 198 adults aged 19–65 with mild to moderate major depressive 
disorder (MDD).
○
Duration: 6 weeks of home-based self-applied tDCS.
2.
Device:
○
MINDD STIM+ (YMS-201B+/201BS+), an FDA-approved tDCS device.
3.
Randomization:
○
Group A: Active tDCS for 6 weeks.
○
Group B: Active tDCS for 3 weeks followed by 3 weeks of sham stimulation.
4.
Primary Outcome Measures:
○
Changes in BDI-II (Beck Depression Inventory-II) and MADRS (Montgomery-
Åsberg Depression Rating Scale) scores from baseline (V1) to week 6 (V3).
5.
Secondary Outcome Measures:
○
HAM-A (Hamilton Anxiety Rating Scale) for anxiety.
○
DSST (Digit Symbol Substitution Test) for cognitive function.
○
CESD-R for daily depressive symptom assessment.
○
qEEG (quantitative EEG) and HRV (heart rate variability).
Participant Criteria

2023.03.23
3
●
Inclusion:
○
Age 19–65, mild to moderate MDD diagnosis.
○
Informed consent capability.
●
Exclusion:
○
PTSD, psychotic MDD, severe suicidal risk, cranial implants, major 
cardiovascular or neurological issues.
○
Prior tDCS use or participation in clinical trials within 30 days.
Statistical Analysis Plan (SAP)
General Overview
The statistical analysis will evaluate both primary and secondary outcomes based on 
intention-to-treat (ITT) and per-protocol (PP) populations.
Primary Statistical Methods
1.
Primary Analysis:
○
Dependent Variables: Changes in BDI-II and MADRS scores from baseline 
to week 6.
○
Methodology:
■
Independent t-tests to compare mean score changes between groups.
■
Mixed-effects models to adjust for repeated measures and site-level 
variation.
2.
Secondary Analysis:
○
Evaluate changes in HAM-A, DSST, and CESD-R scores over time using 
regression analysis.
Adjustments for Multiple Comparisons
To control for Type I error:
●
Bonferroni correction for the analysis of multiple secondary outcomes.
Handling Missing Data
●
Multiple imputation for missing data assuming data are missing at random (MAR).
●
Sensitivity analysis to validate robustness.

2023.03.23
4
Validation of Assumptions
1.
Normality: Shapiro-Wilk test for residuals.
2.
Homogeneity of Variance: Levene’s test.
3.
Sphericity (if repeated measures): Mauchly’s test.
Safety Analysis
●
Descriptive statistics for adverse events (AEs) and serious adverse events (SAEs).
●
AE rates compared using Fisher’s exact test or chi-square test.