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

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial

This trial will try high-definition transcranial direct current stimulation (HD-tDCS) to reduce depressive symptoms in adolescents aged 12–18 with bipolar depression, compared with a sham procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Jiangsu Province Nanjing Brain Hospital (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07246044 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are 12–18 years old, meet DSM criteria for bipolar disorder with a current moderate-to-severe depressive episode (HAMD ≥17 and YMRS <12), are on a stable psychotropic medication regimen, and can provide informed consent with parental permission as required.

Not a fit: Patients with prior brain stimulation (rTMS/tDCS/ECT), uncontrolled or unstable medication or manic symptoms, inability to undergo MRI, or who cannot attend the required in-person twice-daily sessions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this noninvasive approach could provide a tolerable, clinic-delivered option to reduce depressive symptoms in adolescents with bipolar disorder and help identify biomarkers to personalize care.

How similar studies have performed: Some adult tDCS studies have shown modest antidepressant effects, but HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression is a novel and relatively untested approach.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• Affiliated Nanjing Brain Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Lifei Wang

Conditions Adolescent; Bipolar Depression; tDCS; Primary Somatosensory Cortex; Bipolar Disorder Depression; primary somatosensory cortex; adolescent; bipolar depression