Table 2 RATES (Report Approval for Transcranial Electrical Stimulation) checklist.
Participants | Sample Size (Dx), Recruitment Process, Medication | 60 out of initially 71 enrolled patients with unipolar major depression, clinic/hospital referral across Zanjan, Iran (2021-2023), stable medication regimen (n = 50 on medication) | ||
Age(yrs), Sex(F:M), Edu(yrs), Handedness(R:L:D) | 32.5 ± 10.81, 33:27, see Table 1, n/s | |||
Hours of Sleep, Consumption of Caffeine, Nicotine, and Alcohol | Under no sleep pressure, n/s, n/s, n/s | |||
Participant Eligibility Criteria: Aged 18-60 years, failure with at least one antidepressant, stable treatment regimen for at least 6 weeks (or no antidepressants), unipolar depression per DSM-5 (mild to severe per HDRS). Exclusions: other Axis I disorders (except anxiety comorbidity), any Axis II disorders, neurological conditions, tDCS contraindications (e.g., metallic plates, cardiac pacemakers, pregnancy, epilepsy). Native speakers, normal or corrected-to-normal vision. | ||||
Stimulator | Stimulator: Device 1: StarStim 8 (Neuroelectrics, Spain) for multichannel tDCS, Device 2: Oasis Pro, Mind Alive (Canada) | |||
Sham Option | Yes | Waveform | Constant direct current (DC) | |
Output Channels | 8 channels (multichannel); 2 channels (conventional/sham) | Stimulator Safety Features | Both devices had current and voltage limits | |
Current Resolution | n/s | Monitoring and Feedback | In device 1 only | |
Electrodes | Positioning | International 10-20 EEG system | Inter-electrode Distance | 6 cm in conventional tDCS |
Shape | Rectangular (conventional/sham); round (multichannel) | Assembly | elastic headgear in the conventional, cap in the multichannel | |
Size | 35 cm² (conventional/sham); ~3.14 cm² (1 cm radius, multichannel) | Contact Medium | Saline-soaked sponge | |
Orientation | longitudinal along the medio-lateral axis (conventional), n/a to multichannel | Impedance | n/s | |
Material | Rubber | Connector Position | n/s | |
Number: Two electrodes in conventional tDCS and 7 electrodes in the multichannel tDCS | ||||
Montage: Conventional/sham: anode at F3 (left DLPFC), cathode at F4 (right DLPFC). Multichannel: anodes at F3 (1.10 mA), AF3 (1.24 mA), FC6 (1.65 mA); cathodes at F4 (-1.28 mA), AF4 (-1.11 mA), F8 (-0.62 mA), FC5 (-0.97 mA). Optimized via Stimweaver algorithm for excitatory left DLPFC (BA46) and inhibitory right DLPFC. | ||||
Current | Intensity (mA) | 2 mA | Amplitude | Peak to zero |
Density (mA/cm²) | 0.057 mA/cm² (conventional); ~0.20-0.53 mA/cm² (multichannel) | Personalization | Optimized current and configuration in multichannel tDCS | |
Distribution (Method) | Stimweaver algorithm in the multichannel tDCS | Duration (min) | 30 min | |
Frequency (Hz) | n/a | Ramp up/down (sec) | 30:30 | |
Polarity | Anodal (left DLPFC); cathodal (right DLPFC) | Warm-up time (min) | n/a | |
Waveform | Constant direct current | Sham Characteristics | 30:30 | |
Procedure | Study Setting and Site | Experimental lab at the hospital | Attrition (n) | 11 (pre‑endpoint) |
Hypothesis Statement | Exploratory | Blinding Method | double-blinded | |
Preregistration | Preregistered clinical trial | Ethical Considerations | Yes (ethics code: IR.ZUMS.REC.1400.059) | |
Session Duration (min) | 30 min | Safety Monitoring | yes | |
Total Number of Sessions | 30 sessions | Informed Consent Process | yes | |
Session Frequency | 5 sessions per week, (6 weeks) | Conflict of Interest | yes | |
Concurrent Intervention | no | tES operator | Trained tES operator | |
Randomization (Method) | yes (block randomization) | Data Analysis Plan | Mixed‑model ANOVA; modified ITT with MMRM for sensitivity/confirmation | |
Counterbalancing | n/a (parallel‑group RCT) | Data Availability | yes | |
Study Design: Randomized, double-blinded, parallel-group | ||||
Stimulation and Assessment Task Timing: Offline | ||||
Inter-session Interval: 1 day (multi-session design) | ||||
Data Collection Time Points: Post (Side-effect survey) | ||||
Baseline Assessment: yes | ||||
Control Intervention: Sham control (Initial ramp up/down stimulation only) | ||||
Outcome Measure: clinical measures (MADRS-HDRS-BDI-II), cognitive measures (working memory, attention, executive function), EEG (functional connectivity) | ||||
