The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression. As a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
270
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F8 (right supraorbital region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F4 (left dorsolateral prefrontal region), described by Woodham et al., 2024. The application of tDCS will be carried out at home in this group. Each session will consist of 30 minutes of stimulation. Dose: (1) Week 1 to 3: 1ss/day for 5 days; (2) Week 4 to 10: 1ss/day for 3 days (total 36 sessions).
Hospital Universiatrio Doctor Peset
Valencia, Spain
RECRUITINGHDRS-17
Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17).
Time frame: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
MDRS
Changes from baseline to the end of treatment in the Montgomery-Åsberg Depression Rating Scale (MDRS).
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
C-SSRS
Changes from baseline to the end of treatment in the Columbia Suicide Severity Rating Scale (C-SSRS).
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
HAM-A
Changes from baseline to the end of treatment in the Hamilton Anxiety Rating Scale (HAM-A).
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
YMRS
Changes from baseline to the end of treatment in the Young Mania Rating Scale (YMRS).
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
RAVLT
Changes from baseline to the end of treatment in the Rey-Auditory Verbal Learning Test (RAVLT).
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
SDMT
Changes from baseline to the end of treatment in the Symbol Digit Modalities Test (SDMT).
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
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Bristol stool scale
Changes from baseline to the end of treatment in the Bristol Stool Scale.
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Mediterranean Diet Questionnaire
Diet habits of the patients assessed with the Mediterranean diet questionnaire.
Time frame: Baseline
Meal frequency
Meal frequency intake of patients prior to the starting of the project.
Time frame: Baseline
EQ-5D
Changes from baseline to the end of treatment in the EuroQoL-5D questionnaire (EQ-5D).
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
PGI-C
Changes of impression at the end of treatment assess with the Patient Global Impression of Change (PGI-C).
Time frame: End of treatment (3 week experimental; 10 week active comparator)
Resting state EEG
32-channel active-electrode EEG (impedances \<5 kΩ) recordings in open and close eye conditions.
Time frame: Baseline
Stool samples
Changes in stool sample biomarkers from baseline to end of treatment.
Time frame: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).