Intervention Study of Virtual Reality-Based Mindfulness-Based Cognitive Therapy (VR-MBCT) Combined With Adaptive tDCS Modulation for Post-Stroke Depression

Korábbi kezelés

• Presence of suicidal ideation or plan within 4 weeks prior to baseline.
• Received brain stimulation therapy (e.g., ECT, mECT, TMS, rTMS, deep brain stimulation, vagus nerve stimulation) within 3 months prior to baseline.
• Participation in another clinical trial within 1 month prior to baseline (excluding screening failures).

Más betegség

• History of treatment-resistant depression, defined as failure to respond to at least two different antidepressant medications of adequate dosage and duration (at least 8 weeks at the maximum recommended therapeutic dose).
• Other psychiatric diagnoses (e.g., intellectual disability, schizophrenia, affective psychosis, bipolar disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, eating disorders, personality disorders, substance use disorders, post-traumatic stress disorder, panic disorder, or social phobia). Co-morbid anxiety disorder is acceptable.
• Depressive symptoms are better explained by another clinical condition (e.g., hypothyroidism, anemia, congestive heart failure) or other mental disorders.
• Presence of severe, unstable cardiovascular, hepatic, renal, hematological, endocrine diseases, or malignancies.
• Poorly controlled hypertension (sitting systolic blood pressure (SBP) ≥ 180 mmHg or sitting diastolic blood pressure (DBP) ≥ 110 mmHg at screening or baseline).
• Epilepsy and/or other neurological diseases (e.g., dementia, traumatic brain injury, Parkinson's disease, Huntington's disease, multiple sclerosis), or any neurological condition leading to increased intracranial pressure, brain damage, or increased risk of seizures.
• Significant visual or hearing impairment that prevents participation in interventions or assessments.
• Any other condition deemed by the investigator as unsuitable for participation in the study.

Laborértékek

• Laboratory tests indicating significant impairment: total bilirubin (TBIL) > 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times ULN; glomerular filtration rate (GFR) ≤ 70 mL/min; or thyroid-stimulating hormone (TSH) outside the normal range.

Egyéb

• Baseline Mini-Mental State Examination (MMSE) score ≤ 24.
• Pregnant, lactating, or planning pregnancy.

• Aged 18 to 65 years (inclusive).
• Stroke onset ≥ 4 weeks, with stable condition and an NIHSS score ≤ 15.
• Right-handed.
• Patient must be in a depressive episode, defined by a PHQ-9 score ≥ 5 and confirmed by a HDRS-24 score ≥ 8.
• Has not used any antidepressants before the enrollment.
• No contraindications to tDCS (e.g., metal plates in the head, brain implants, aneurysm clips, cochlear implants, cardiac pacemakers, etc.).
• Has not received systematic psychotherapy (such as MBCT, mindfulness training, or cognitive behavioral therapy) for the current or previous depressive episodes.
• Has more than 8 years of formal education.
• Has not received tDCS or other transcranial electrical stimulation treatment for the current or previous depressive episodes.
• Is able to cooperate with multimodal MRI data collection and follow-up assessments, and can understand and comply with the study requirements.