Tests a remote limb treatment to prevent depression after stroke
Tests remote ischemic conditioning, a device-based treatment, in adults at risk of post-stroke depression.
Plain-language title generated from the registry record
Registry title: Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression
Key facts
- Where
- Baoding, Beijing, Jilin City, Jincheng, and Tongren, ChinaSee the 5 sites
Where in China
- Baoding People's HospitalBaoding, ChinaNo longer taking part
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- Jilin People's HospitalJilin City, ChinaNo longer taking part
- Jincheng People's HospitalJincheng, ChinaNo longer taking part
- Tongren City People's HospitalTongren, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT06920706
- Record updated
- 10 April 2025
- Original description
Post-stroke depression (PSD) is characterized primarily by low mood and loss of interest following a stroke. It is one of the most common and serious complications of stroke, with an incidence of 11% to 41% within two years post-stroke. PSD significantly impacts stroke prognosis, not only hindering neurological recovery but also increasing clinical disability and mortality rates, thereby imposing substantial economic and psychological burdens on families and society. Therefore, preventing PSD is crucial for stroke rehabilitation.Read full original descriptionShow less
Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Trial
Post-stroke depression (PSD) is characterized primarily by low mood and loss of interest following a stroke. It is one of the most common and serious complications of stroke, with an incidence of 11% to 41% within two years post-stroke. PSD significantly impacts stroke prognosis, not only hindering neurological recovery but also increasing clinical disability and mortality rates, thereby imposing substantial economic and psychological burdens on families and society. Therefore, preventing PSD is crucial for stroke rehabilitation.
Clinical trials have demonstrated that preventive antidepressant treatment can reduce PSD incidence and improve clinical outcomes; however, controversies remain regarding the timing, methods, and safety. Meanwhile, preventive psychological therapy faces challenges in implementation due to effectiveness, accessibility, and cost-effectiveness.
Remote ischemic preconditioning (RIC) is a non-invasive, cost-effective, and non-pharmacological intervention. By modulating small molecules in the peripheral and central nervous systems through transient, periodic limb blood flow restriction and reperfusion, RIC reverses neurobiological changes and demonstrates neuroprotective potential in various neurological diseases. Recently, a study showed that RIC is safe and effective in preventing PSD; however, the sample size is small and the specific mechanisms remain unclear. Therefore, this study aims to further explore the role and mechanisms of RIC in PSD prevention.
Inclusion: Patient age≥18 years; No gender preference; Diagnosed with acute ischemic stroke; From onset to treatment ≤48 h; 6≤ NIHSS scores ≤25; Premorbid mRS ≤1; Signed informed consent.
Exclusion: Any contraindication for magnetic resonance imaging: metal implants, claustrophobia, etc; A history of severe mental illness such as depression, bipolar disorder, and schizophrenia; A history of mental disorders caused by other organic diseases, such as post-Parkinson depression; Participants with cognitive impairment, disturbance of consciousness, severe hearing impairment, or aphasia who were unable to cooperate with the assessment; A history of autoimmune diseases (such as multiple sclerosis, neuromyelitis optica spectrum disorders, systemic lupus erythematosus, etc.), malignant tumors, or obstructive sleep apnea hypopnea syndrome; Uncontrolled severe hypertension (systolic pressure >180mmHg or diastolic pressure >110 mmHg after drug treatment) ; Subclavian artery stenosis≥50% or subclavian steal syndrome; Severe coagulation dysfunction, platelet count < 100×10\^9/L, cardiac dysfunction (NYHA class Ⅲ or above), hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase > 3 times the upper limit of normal), or renal dysfunction (serum creatinine > 265μmol/L); Baseline HAMD-24 scores ≥8; Infarction area overlapped with the area where the DTI-ALPS index is calculated; Intracranial tumor, arteriovenous malformation, or aneurysm; Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc; Women known to be pregnant or lactating, or have a positive pregnancy test; Participating in other clinical trials within three months; Participants not suitable for this clinical studies considered by researcher.