HD-tDCS for Adolescent Bipolar Depression Targeting S1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active HD-tDCS, Antipsychotics, mood stabilizers, etc., Sham HD-tDCS.
- Who it may be relevant to
- Registry conditions: Adolescent, Bipolar Depression, tDCS, Primary Somatosensory Cortex. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial
Overview
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.
Detailed description
This study aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex (S1) in adolescents with bipolar depression. Participants will be randomly assigned (1:1) to receive either active HD-tDCS or sham stimulation for 10 consecutive days (twice daily, 20 minutes each session), in addition to standard clinical care.
Multimodal assessments will be conducted at baseline, mid-treatment (after 10 sessions), and post-treatment, including clinical symptom scales, neurocognitive evaluations, structural and functional MRI, blood biomarkers (15ml of peripheral blood), as well as digital phenotyping data such as voice, EEG, PPG, sleep, and behavioral metrics.
The study also aims to identify objective biomarkers predictive of treatment response and to elucidate the neurobiological mechanisms associated with HD-tDCS applied to the S1 region. All procedures including MRI, tDCS, and assessments are non-invasive and free of charge for participants. The total duration of data collection and follow-up is expected to span approximately two years.
Interventions
- Device Active HD-tDCS
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. - Drug Antipsychotics, mood stabilizers, etc.
During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines. - Device Sham HD-tDCS
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.
Primary outcome measures
- Change from baseline in depressive symptoms assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at Week 2. [Time frame: Baseline and after 2 weeks.]
Secondary outcome measures (8)
- Change from baseline in depressive symptoms assessed by HAMD-17 after week 1. [Time frame: Baseline and after 1 week.]
- Change in anxiety symptoms assessed by Hamilton Anxiety Rating Scale (HAMA) after week 1 and after week 2. [Time frame: 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. [Time frame: 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. [Time frame: Baseline, after 1 week and after 2 weeks.]
- Change in brain functional connectivity measured by resting-state functional MRI [Time frame: Baseline, after 1 week and after 2 weeks.]
- Change in Cytokines (reported in pg/mL) [Time frame: Baseline, after 1 week, and after 2 weeks.]
- Change in Immune-inflammatory ratios (unitless) [Time frame: Baseline, after 1 week, and after 2 weeks.]
- Adverse events and tolerability of HD-tDCS [Time frame: Baseline, after 1 week and after 2 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Nanjing Brain Hospital, Nanjing Medical University — Nanjing
Identifiers
NCT: NCT07246044 · 81725005-10