RecruitingNot ApplicableNCT07246044

HD-tDCS for Adolescent Bipolar Depression Targeting S1

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial

Sponsor

Jiangsu Province Nanjing Brain Hospital

Enrollment

100 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Adolescent tDCS Bipolar Depression Primary Somatosensory Cortex Bipolar Disorder Depression

Summary

This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. Participants will be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care. Biological data, including neuroimaging, blood biomarkers, voice and facial features, Photoplethysmography (PPG), Electroencephalography (EEG), and behavioral data, will be collected to explore potential predictors of treatment response.

Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests high-definition transcranial direct current stimulation (HD-tDCS) — a gentle, non-invasive brain stimulation technique using mild electrical currents — as a treatment for depression in teenagers with bipolar disorder. It targets a specific brain region called the primary somatosensory cortex (S1) to see if it reduces depressive symptoms. **You may be eligible if...** - You are 12 to 18 years old - You have been diagnosed with bipolar disorder and are currently experiencing a depressive episode - Your diagnosis meets DSM-IV criteria for bipolar disorder **You may NOT be eligible if...** - You have metal implants in your head or a pacemaker - You have a history of seizures or epilepsy - You have significant other neurological conditions - You are currently experiencing a manic or psychotic episode Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive HD-tDCS

HD-tDCS is a non-invasive neuromodulation therapy which has been recognized as a helpful treatment for depression. During each HD-tDCS treatment, the electrode field is generated by a 4\*1 ring montage which is placed over the scalp on the brain region of interest with an electrical current induced to modulate brain activity.

DRUGAntipsychotics, mood stabilizers, etc.

During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines.

DEVICESham HD-tDCS

Sham HD-tDCS is administered using the same electrode configuration as the active HD-tDCS condition. During each session, the device ramps up current briefly (typically 30 seconds) to mimic the initial sensation of stimulation, then remains off for the remainder of the 20-minute session. This method produces the same tactile perception as active stimulation without delivering a therapeutic dose of current.