Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
NCT07246044

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

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Affiliated Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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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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