Study of Transcranial Alternating Current Stimulation tACS for Treating Depression in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating transcranial alternating current stimulation tACS, a non-invasive technique, for treating major depression. This multicenter randomized controlled trial aims to assess the effectiveness and safety of tACS in patients diagnosed with depression who have a Hamilton Depression Rating Scale HDRS-17 score of 8 or higher, aged 18 to 65 years. This study is motivated by the potential benefits of tACS compared to other therapies that carry higher risks and costs. Participants will be randomly assigned to one of two groups an active tACS treatment group or a sham placebo stimulation group. The active tACS involves 40-minute sessions of continuous sine-wave stimulation at 10 Hz frequency and an amplitude between 1.5 and 2.0 mA, adjusted for patient comfort. The sham group receives a brief fade-in and fade-out stimulation to mimic treatment without therapeutic effects. The intervention lasts four weeks and includes 20 sessions in total, followed by an additional four-week observation period without treatment. During the study, participants will undergo assessments at the start, after two and four weeks of treatment, and at six and eight weeks from the beginning. Evaluations include psychological scales to measure mental health and quality of life, as well as electroencephalogram EEG recordings and magnetic resonance imaging MRI scans to observe brain activity and connectivity changes related to depression. The primary outcome is clinical remission four weeks after intervention completion, with monitoring for any adverse events continuing until the study ends at eight weeks.

Efficacy and Safety of tACS for Depression: a Multicenter RCT Study