Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Treatment for Major Depressive Episode

Launched by JIANGSU PROVINCE NANJING BRAIN HOSPITAL · Aug 10, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for adolescents aged 13 to 18 who are struggling with major depression or bipolar disorder. The study is testing a personalized approach to High-Definition Transcranial Direct Current Stimulation (HD-tDCS), a non-invasive technique that uses mild electrical currents to stimulate specific areas of the brain. Researchers want to see if tailoring the treatment based on brain scans can improve its effectiveness compared to standard methods. Participants must have a moderate to severe depressive episode and be on a stable medication regimen, among other criteria.

If eligible, participants can expect to undergo brain imaging to guide their personalized treatment. Throughout the study, they will continue taking their current medications while receiving HD-tDCS. The trial aims to determine how safe and effective this personalized approach is and to better understand how it works in the brain. It's important to note that individuals with certain medical conditions or previous treatments for depression may not qualify for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Between 13 and 18 years of age;
• • Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for major depressive disorder (MDD) or bipolar disorder (BD);
• • Participants are assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL);
• • A current moderate or severe depressive episode defined by HAMD\>17;
• • Participants receive a stable psychotropic medication regimen prior to randomization to the trial and patient will be willing to remain on the stable regimen during the HD-tDCS treatment phase;
• • All participants provided written informed consent by themselves or their guardians after the detailed description of the study.
• Exclusion Criteria:
• • Prior rTMS, tDCS, electroconvulsive therapy (ECT) application 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, metalimplants);
• • Contraindications to HD-tDCS (e.g., scalp rupture, cranial plates, history of seizure,electroencephalogram (EEG) test suggesting high risk of seizure, known brain lesion);
• • Current drug/alcohol abuse or dependence;Pregnant or lactating female.