Post-stroke Depression
Conditions
Interventions
Control group:tTIS sham stimulation therapy and conventional drug therapy
Experimental group:tTIS real stimulation therapy and conventional drug therapy
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for "Stroke" as defined in the Diagnostic Essentials of Major Cerebrovascular Diseases in China 2019, and confirmed by cranial CT or MRI. 2.More than 1 month post-stroke onset, currently in a stable clinical phase. 3.Aged between 18 and 80 years (inclusive). 4.Meet the diagnostic criteria for "Depressive Episode" according to the *International Classification of Diseases, Eleventh Revision (ICD-11)*, with the onset occurring after the stroke event. 5.A score of >= 17 on the 17-item Hamilton Depression Rating Scale (HAMD-17). 6.A score of >= 22 on the Mini-Mental State Examination (MMSE), excluding severe cognitive impairment that may interfere with mood assessment. 7.Medically and neurologically stable, as determined by the investigator based on medical history, physical, and neurological examinations. 8.The patient provides informed consent and commits to completing the entire treatment and assessment protocol.
Exclusion criteria
Exclusion criteria: 1.Depressive state not directly caused by the stroke, or a history of depressive disorder prior to the stroke. 2.Presence of other progressive neurological diseases (e.g., Parkinson's disease, dementia). 3.Presence of aphasia, severe sensory aphasia, or cognitive impairment that precludes cooperation with scale assessments. 4.Presence of suicide risk (a score of >= 3 on item 3 of the HAMD-17) or comorbid other severe mental disorders (e.g., schizophrenia, bipolar disorder). 5.Having received neuromodulation therapies such as Modified Electroconvulsive Therapy (MECT) or repetitive Transcranial Magnetic Stimulation (rTMS) within the past 1 month. 6.Comorbid severe or unstable cardiovascular, hepatic, renal, or other systemic diseases. 7.Contraindications to MRI scanning (e.g., implanted metal devices, claustrophobia). 8.Pregnancy or lactation. 9.Current participation in another interventional clinical trial. 10.Any other condition that, in the investigator's judgment, may significantly affect study compliance, increase safety risks, or interfere with outcome assessments, rendering the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17-item Hamilton Depression Rating Scale (HAMD-17);16-item Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR-16); | — |
Secondary
| Measure | Time frame |
|---|---|
| EuroQol-5 Dimensions 3-Level version (EQ-5D-3L);Work and Social Adjustment Scale (WSAS);Structural Magnetic Resonance Imaging;EEG-fNIRS;Sheehan Disability Scale (SDS);Functional Magnetic Resonance Imaging;Positive and Negative Affect Schedule (PANAS);7-item Generalized Anxiety Disorder scale (GAD-7);Diffusion Tensor Imaging (DTI); | — |
Countries
China
Contacts
Public ContactZhouping Tang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed