High-definition tDCS targeting the primary somatosensory cortex for adolescent bipolar depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled trial enrolling adolescents with bipolar depression to receive either active HD-tDCS or sham stimulation alongside routine clinical care. Active or sham stimulation is delivered for 10 consecutive days with two 20-minute sessions per day. Multimodal assessments are performed at baseline, mid-treatment, and post-treatment and include clinical scales, neurocognitive testing, structural and functional MRI, blood biomarkers, EEG, photoplethysmography, voice and facial metrics, sleep, and behavioral data. The study also seeks objective biomarkers and neurobiological mechanisms that predict or accompany clinical response to S1-targeted HD-tDCS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening;
* Comorbidity of other DSM-IV axis I disorders or personality disorders;
* Judged clinically to be at serious suicidal risk;
* 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 MRI (e.g., severe claustrophobia, pacemakers, metal implants);
* Contraindications to tDCS (e.g., metal in head, history of seizure, EEG test suggesting high risk of seizure, known brain lesion);
* Current drug/alcohol abuse or dependence;
* Pregnant or lactating female.

Where it's running

• Affiliated Nanjing Brain Hospital, Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Lifei Wang
• Email: lifeiwang@stu.njmu.edu.cn
• Phone: 86-13390599200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.