Actively Recruiting
High-Definition Transcranial Direct Current Stimulation Targeting Primary Somatosensory Cortex for Bipolar Depression in Adolescents: Randomized Double-Blind Controlled Trial
Led by Jiangsu Province Nanjing Brain Hospital · Updated on 2025-11-24
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects and biological mechanisms of high-definition transcranial direct current stimulation (HD-tDCS) targeting the primary somatosensory cortex in adolescents aged 12 to 18 years with bipolar depression. This randomized, double-blind, sham-controlled trial compares active HD-tDCS with sham stimulation, alongside routine clinical care, to assess changes in depressive symptoms and explore biological markers that may predict treatment response. Participants are randomly assigned to receive either active HD-tDCS or sham stimulation for 10 consecutive days, with two 20-minute sessions each day, totaling 20 sessions. Active stimulation involves applying a 2.0 mA current at specific scalp locations while sham sessions mimic the sensation without delivering current. All participants continue stable medication during the treatment phase. The study includes baseline, mid-treatment, and post-treatment assessments over approximately two years. During the study, participants undergo comprehensive evaluations including clinical symptom scales, neurocognitive tests, and multimodal imaging such as structural and functional MRI. Biological samples like blood biomarkers are collected, along with digital data including voice, EEG, photoplethysmography, sleep, and behavioral measurements. The main outcome is the change in depressive symptoms after two weeks, monitored alongside safety and tolerability. All procedures are non-invasive and free for participants.
CONDITIONS
Brief 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 using structured clinical interviews
- Experiencing a moderate or severe depressive episode defined by HAMD score 6517 and YMRS score less than 12
- On a stable psychotropic medication regimen before starting the trial and willing to maintain it during treatment
- Participants and one or two parents (if under 18) provide informed consent after study details are explained
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 suicidal risk by clinical judgment
- Have diabetes, hypertension, vascular, infectious, or other major medical conditions
- Have unstable medical conditions such as severe asthma
- Have neurological disorders including significant head injury, cerebrovascular disease, brain tumors, or neurodegenerative diseases
- Have mental retardation or autism spectrum disorder
- Have contraindications to MRI (e.g., claustrophobia, pacemakers, metal implants)
- Have contraindications to tDCS (e.g., metal in head, history or high risk of seizure, known brain lesions)
- Have current drug or alcohol abuse or dependence
- Are pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 consecutive days
Participants receive either active or sham HD-tDCS targeting the primary somatosensory cortex twice daily for 10 consecutive days, alongside stable medication regimens. Multimodal assessments including clinical scales, MRI, blood biomarkers, and digital phenotyping are conducted at baseline, mid-treatment, and post-treatment.
20 visits (twice daily sessions)
Duration - Up to 2 years
Participants are followed for ongoing assessment of depressive symptoms, anxiety, brain function, and safety outcomes up to approximately two years after treatment.
Multiple follow-up visits over 2 years
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
J
Jia Duan
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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