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
Jiangsu Province Nanjing Brain Hospital
100 participants
Sep 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Between 12 and 18 years of age;
- Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K- SADS-PL, patients' age\< 18 years old);
- A current moderate or severe depressive episode defined by HAMD≥17 and Young Mania Rating Scale (YMRS) \<12;
- Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the HD-tDCS treatment phase;
- Participants and 1 or 2 parents (patients' age\< 18 years old) provide informed consent after the detailed description of the study.
Exclusion Criteria11
- Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening;
- Comorbidity of other DSM-IV axis I disorders or personality disorders;
- Judged clinically to be at serious suicidal risk;
- Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;
- Unstable medical conditions, e.g., severe asthma;
- Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;
- Mental retardation or autism spectrum disorder;
- Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);
- Contraindications to tDCS (e.g., metal in head, history of seizure, EEG test suggesting high risk of seizure, known brain lesion);
- Current drug/alcohol abuse or dependence;
- Pregnant or lactating female.
Interventions
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.
During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07246044