HD-tDCS for Adolescent Bipolar Depression Targeting S1

NCT07246044 | Recruiting

• 1 other identifier: 81725005-10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Adolescent; Bipolar Depression; tDCS; Primary Somatosensory Cortex; Bipolar Disorder Depression

Keywords

primary somatosensory cortex; adolescent; bipolar depression; high-definition transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in depressive symptoms assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at Week 2.

  The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.

  Baseline and after 2 weeks.

Secondary Outcomes (8)

• Change from baseline in depressive symptoms assessed by HAMD-17 after week 1.

  Baseline and after 1 week.

• Change in anxiety symptoms assessed by Hamilton Anxiety Rating Scale (HAMA) after week 1 and after week 2.

  Baseline, after 1week and after 2 weeks.

• Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) after week 1 and after week 2.

  Baseline and after 1 week and after 2 weeks.

• Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) after 1 week and after 2 week.

  Baseline, after 1 week and after 2 weeks.

• Change in brain functional connectivity measured by resting-state functional MRI

  Baseline, after 1 week and after 2 weeks.

Study Arms (2)

Active HD-tDCS Targeting Right S1

EXPERIMENTAL

Participants in this arm will receive active HD-tDCS targeting the right S1. Anodal stimulation will be delivered at the C4 position according to the international 10-20 EEG system, with cathodes placed at FC4, C6, C2, and CP4. The current intensity is set at 2.0 mA for 20 minutes per session, administered twice daily for 10 days (total of 20 sessions). Participants received stable pharmacological treatment during the intervention period.

Device: Active HD-tDCS; Drug: Antipsychotics, mood stabilizers, etc.

Sham Stimulation at Right S1

SHAM COMPARATOR

Participants in this arm will receive sham HD-tDCS using the same electrode configuration as the active group (anode at C4; cathodes at FC4, C6, C2, and CP4), but without delivering effective current after the initial ramp-up. The sham stimulation mimics the sensation of real stimulation without physiological effects. Sessions will be delivered twice daily for 10 days (total of 20 sessions). Participants received stable pharmacological treatment during the intervention period.

Drug: Antipsychotics, mood stabilizers, etc.; Device: Sham HD-tDCS

Interventions

Active HD-tDCS DEVICE

HD-tDCS is a non-invasive neuromodulation therapy which has been recognized as a helpful treatment for depression. During each HD-tDCS treatment, the electrode field is generated by a 4\*1 ring montage which is placed over the scalp on the brain region of interest with an electrical current induced to modulate brain activity.

Active HD-tDCS Targeting Right S1

Antipsychotics, mood stabilizers, etc. DRUG

During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines.

Active HD-tDCS Targeting Right S1; Sham Stimulation at Right S1

Sham HD-tDCS DEVICE

Sham HD-tDCS is administered using the same electrode configuration as the active HD-tDCS condition. During each session, the device ramps up current briefly (typically 30 seconds) to mimic the initial sensation of stimulation, then remains off for the remainder of the 20-minute session. This method produces the same tactile perception as active stimulation without delivering a therapeutic dose of current.

Sham Stimulation at Right S1

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Affiliated Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Fei Wang

  the Affiliated Nanjing Brain Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Lifei Wang

CONTACT

86-13390599200; lifeiwang@stu.njmu.edu.cn

Jia Duan

CONTACT

86-025-83295957; jia_duan@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 24, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)