Evaluating HD-tDCS Treatment on the Primary Somatosensory Cortex for Adolescents with Bipolar Depression in a Randomized Double-Blind Trial

What this Trial Is About

Researchers are studying the effects and biological mechanisms of high-definition transcranial direct current stimulation HD-tDCS targeting the primary somatosensory cortex in adolescents aged 12 to 18 years with bipolar depression. This randomized, double-blind, sham-controlled trial compares active HD-tDCS with sham stimulation, alongside routine clinical care, to assess changes in depressive symptoms and explore biological markers that may predict treatment response. Participants are randomly assigned to receive either active HD-tDCS or sham stimulation for 10 consecutive days, with two 20-minute sessions each day, totaling 20 sessions. Active stimulation involves applying a 2.0 mA current at specific scalp locations while sham sessions mimic the sensation without delivering current. All participants continue stable medication during the treatment phase. The study includes baseline, mid-treatment, and post-treatment assessments over approximately two years. During the study, participants undergo comprehensive evaluations including clinical symptom scales, neurocognitive tests, and multimodal imaging such as structural and functional MRI. Biological samples like blood biomarkers are collected, along with digital data including voice, EEG, photoplethysmography, sleep, and behavioral measurements. The main outcome is the change in depressive symptoms after two weeks, monitored alongside safety and tolerability. All procedures are non-invasive and free for participants.

HD-tDCS for Adolescent Bipolar Depression Targeting S1