An interventional study of Active HD-tDCS and Antipsychotics, mood stabilizers, etc. in Adolescent, Bipolar Depression and tDCS, sponsored by Jiangsu Province Nanjing Brain Hospital. Recruiting at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Jiangsu Province Nanjing Brain Hospital · Not applicable, Interventional, and Treatment
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.
This study aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex (S1) in adolescents with bipolar depression. Participants will be randomly assigned (1:1) to receive either active HD-tDCS or sham stimulation for 10 consecutive days (twice daily, 20 minutes each session), in addition to standard clinical care.
Multimodal assessments will be conducted at baseline, mid-treatment (after 10 sessions), and post-treatment, including clinical symptom scales, neurocognitive evaluations, structural and functional MRI, blood biomarkers (15ml of peripheral blood), as well as digital phenotyping data such as voice, EEG, PPG, sleep, and behavioral metrics.
The study also aims to identify objective biomarkers predictive of treatment response and to elucidate the neurobiological mechanisms associated with HD-tDCS applied to the S1 region. All procedures including MRI, tDCS, and assessments are non-invasive and free of charge for participants. The total duration of data collection and follow-up is expected to span approximately two years.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's planned enrollment of 100 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Jiangsu Province Nanjing Brain Hospital is the lead sponsor of 22 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will receive active HD-tDCS targeting the right S1. Anodal stimulation will be delivered at the C4 position according to the international 10-20 EEG system, with cathodes placed at FC4, C6, C2, and CP4. The current intensity is set at 2.0 mA for 20 minutes per session, administered twice daily for 10 days (total of 20 sessions). Participants received stable pharmacological treatment during the intervention period.
Device: Active HD-tDCS · Drug: Antipsychotics, mood stabilizers, etc.
Participants in this arm will receive sham HD-tDCS using the same electrode configuration as the active group (anode at C4; cathodes at FC4, C6, C2, and CP4), but without delivering effective current after the initial ramp-up. The sham stimulation mimics the sensation of real stimulation without physiological effects. Sessions will be delivered twice daily for 10 days (total of 20 sessions). Participants received stable pharmacological treatment during the intervention period.
Drug: Antipsychotics, mood stabilizers, etc. · Device: Sham 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.
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.
Change from baseline in depressive symptoms assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at Week 2.
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.
Time frame: Baseline and after 2 weeks.
Change from baseline in depressive symptoms assessed by HAMD-17 after week 1.
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.
Time frame: Baseline and after 1 week.
Change in anxiety symptoms assessed by Hamilton Anxiety Rating Scale (HAMA) after week 1 and after week 2.
The HAMA consists of 14 items designed to assess the severity of a patient's anxiety. Each item is rated on a scale of 0 (not present) to 4 (severe), with a total score ranging from 0 to 56. Higher scores indicate greater anxiety. Change in total score from baseline will be calculated.
Time frame: Baseline, after 1week and after 2 weeks.
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) after week 1 and after week 2.
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Time frame: Baseline and after 1 week and after 2 weeks.
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) after 1 week and after 2 week.
MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.
Time frame: Baseline, after 1 week and after 2 weeks.
Change in brain functional connectivity measured by resting-state functional MRI
Resting-state functional magnetic resonance imaging (rs-fMRI) will be used to assess changes in the connectivity of the primary S1 and associated networks.
Time frame: Baseline, after 1 week and after 2 weeks.
Change in Cytokines (reported in pg/mL)
Peripheral blood biomarkers will be measured to evaluate inflammatory and immune responses to HD-tDCS treatment. Interferon-α (IFN-α) Interferon-γ (IFN-γ) Interleukin-1β (IL-1β) Interleukin-2 (IL-2) Interleukin-4 (IL-4) Interleukin-5 (IL-5) Interleukin-6 (IL-6) Interleukin-8 (IL-8) Interleukin-10 (IL-10) Interleukin-17 (IL-17) Tumor necrosis factor-alpha (TNF-α)
Time frame: Baseline, after 1 week, and after 2 weeks.
Change in Immune-inflammatory ratios (unitless)
Platelet-to-lymphocyte ratio (PLR) Neutrophil-to-lymphocyte ratio (NLR) Monocyte-to-HDL cholesterol ratio (MHR) These biomarkers are selected to reflect systemic inflammatory activity and immune status.
Time frame: Baseline, after 1 week, and after 2 weeks.
Adverse events and tolerability of HD-tDCS
Adverse events related to HD-tDCS will be monitored throughout the treatment period. Participants will be evaluated for scalp irritation, headache, dizziness, fatigue, or other discomforts after each session. Severity and frequency will be recorded using a standardized adverse event form.
Time frame: Baseline, after 1 week and after 2 weeks
Plan to share: No
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Jiangsu Province Nanjing Brain Hospital