Brain Stimulation Targeting the Sensory Cortex for Depression in Teens With Bipolar Disorder
Tests gentle electrical brain stimulation against sham stimulation in teenagers with bipolar depression.
Plain-language title generated from the registry record
Registry title: HD-tDCS for Adolescent Bipolar Depression Targeting S1
Key facts
- Where
- Nanjing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 18 years old?
Source: NCT07246044, who can take part
Where in China
- Affiliated Nanjing Brain Hospital, Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Province Nanjing Brain Hospital
- Trial code
- NCT07246044
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial
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.
Inclusion: 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: Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening; Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants); Current drug/alcohol abuse or dependence; Comorbidity of other DSM-IV axis I disorders or personality disorders; 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 tDCS (e.g., metal in head, history of seizure, EEG test suggesting high risk of seizure, known brain lesion); Judged clinically to be at serious suicidal risk; Pregnant or lactating female.