Acute ischemic stroke/post-stroke depression
Conditions
Interventions
RIC intervention group:Ischemic preconditioning training device, upper arm pressure of 200mmHg, 5-minute pressure/5-minute relaxation, 5 cycles/time, twice a day, treatment course of 10-14 days.
Sham RIC group:Ischemic preconditioning training device, upper arm pressure of 60mmHg, 5-minute pressure/5-minute relaxation, 5 cycles/time, twice a day, treatment course of 10-14 days.
Sponsors
Tongren People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years, male or female; 2.Diagnosed with acute ischemic stroke confirmed by CT/MRI; 3.Intervention can be initiated within 7 days of symptom onset; 4.Baseline NIHSS score 2–18, stable vital signs; 5.Pre-stroke mRS <=2; 6.No DSM-5 diagnosis of depressive disorder at baseline; 7.Signed informed consent and able to complete 90-day/180-day follow-up.
Exclusion criteria
Exclusion criteria: 1.Those who meet the DSM-5 diagnostic criteria for depression caused by other physical illnesses at baseline; Or HAMD-24 score >= 20 points, indicating the presence of moderate to severe depressive symptoms and the need for immediate initiation of standardized antidepressant treatment. Explanation: Patients with baseline HAMD-24 scores of 8-19 are not excluded, but their scores are recorded and adjusted as important covariates in random stratification or statistical models. 2. Individuals who have been diagnosed with severe mental illnesses such as major depressive disorder, bipolar disorder, and schizophrenia, and still require systematic treatment within the past year; 3. Previous mental disorders caused by other organic diseases, such as Parkinson's disease-related depression, Alzheimer's disease-related behavioral symptoms, etc; 4. Diagnosed with dementia, Alzheimer's disease, Parkinson's disease, dementia, or other severe neurodegenerative diseases before stroke; Or those who have consciousness disorders, severe aphasia, severe hearing or visual impairments, which prevent them from completing the main scale assessment; 5. Individuals with active autoimmune diseases or undergoing high-dose immunosuppressive therapy; Active malignant tumors or those with a life expectancy of less than one year; Severe obstructive sleep apnea hypopnea syndrome, untreated and judged by researchers to significantly affect mood and sleep assessors; 6. Intracranial tumors, arteriovenous malformations, untreated high-risk ruptured aneurysms, or other intracranial structural lesions that researchers determine may affect the safety and outcome of the study; 7. Hypertension that is difficult to control with medication, with systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg after medication; 8. Patients with subclavian artery stenosis >= 50%, subclavian artery steal syndrome, or those with significant arterial blood supply disorders in the upper limbs undergoing intervention; 9.There are contraindications for ischemic adaptation therapy, such as upper limb skin and soft tissue injuries, fractures, severe peripheral arterial disease, arteriovenous fistulas, upper limb deep vein thrombosis, severe pain, or inability to tolerate cuff compression; 10. Severe coagulation dysfunction, platelet count3 times the upper limit of normal, or renal dysfunction, blood creatinine>265 µ mol/L; 11. Known pregnant or lactating women, or positive pregnancy test results; 12. Have participated in other clinical studies of drugs or devices that may affect the outcome of this study within the past 3 months prior to participation or enrollment; 13. There are situations where other researchers consider it unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-stroke depression at 90 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28 day and 180 day PSD incidence rates and depression symptom scores;Incidence of post-stroke depression at 28 days after randomization;Occurrence of post-stroke depression at day 180 long-term follow-up after randomization;Cumulative incidence of post-stroke depression within 180 days after randomization;Change in HAMD-24 score from baseline;Proportion of participants initiating antidepressant medication at day 90 and day 180 long-term follow-up after randomization;Proportion of participants receiving psychological intervention at day 90 and day 180 long-term follow-up after randomization;Occurrence of post-stroke anxiety at day 90 and day 180 long-term follow-up after randomization;Change in HAMA-14 score from baseline;Change in NIHSS score from baseline;Change in Fugl-Meyer Assessment score from baseline;Proportion of participants with modified Rankin Scale score of 0 to 2 at day 90 and day 180 long-term follow-up after randomization;Change in MMSE or MoCA score from baseline;Change in Pittsburgh Sleep Quality Index score from baseline;Change in EQ-5D-5L score from baseline;Total length of hospital stay within 180 days after randomization;Number of stroke-related readmissions within 180 days after randomization; | — |
Countries
China
Contacts
Public ContactLina Jia
Tongren People’s Hospital
Outcome results
None listed