Actively Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Led by Jiangsu Province Nanjing Brain Hospital · Updated on 2025-11-24
100
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 12 and 18 years of age
- Diagnosed with bipolar disorder according to DSM-IV criteria
- Currently experiencing moderate or severe depressive episode with HAMD score of 17 or higher and YMRS score below 12
- On a stable psychotropic medication regimen prior to the study and willing to maintain it during treatment
- Participant and at least one parent (if under 18) provide informed consent after study explanation
You will not qualify if you...
- Received rTMS, tDCS, electroconvulsive therapy, or standard psychological therapy within 6 months before screening
- Have other DSM-IV Axis I disorders or personality disorders
- Considered at serious risk of suicide
- Have diabetes, hypertension, vascular, infectious, or other major medical conditions
- Have unstable medical conditions such as severe asthma
- Have neurological disorders including head injury with loss of consciousness for 5 minutes or more, cerebrovascular disease, brain tumors, or neurodegenerative diseases
- Have mental retardation or autism spectrum disorder
- Have contraindications to MRI such as pacemakers, metal implants, or severe claustrophobia
- Have contraindications to tDCS such as metal in the head, history of seizures, high seizure risk on EEG, or known brain lesions
- Currently abusing or dependent on drugs or alcohol
- Are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Nanjing Brain Hospital, Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
L
Lifei Wang
CONTACT
J
Jia Duan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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