NCT07246044Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT07246044
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 15 Oct 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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);
Other
- Judged clinically to be at serious suicidal risk;
- Pregnant or lactating female.
Who the study is looking for
- 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.
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Nanjing Brain Hospital, Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.