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ClinicalTrials.gov ID

NCT06920706

Lead Sponsor

Xuanwu Hospital, BeijingOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

240Estimated

Last Update Posted

Apr 10, 2025Actual

Start Date

Apr 10, 2025Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

Official Title

Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Trial

Brief Summary

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.

Detailed Description

This multicenter, randomized, double-blind, sham controlled clinical study will enroll acute ischemic stroke patients within 48 hours of symptom onset. Eligible participants will be randomly allocated (1:1) to receive either remote ischemic conditioning (RIC) or sham-RIC treatment for 14 consecutive days. The primary outcome is the incidence of post-stroke depression at day 14 post-randomization.

• Post-stroke Depression
• Remote Ischemic Conditioning

• RIC
• Sham-RIC

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• Baseline HAMD-24 scores ≥8;
• Infarction area overlapped with the area where the DTI-ALPS index is calculated;
• 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;
• Intracranial tumor, arteriovenous malformation, or aneurysm;
• Uncontrolled severe hypertension (systolic pressure >180mmHg or diastolic pressure >110 mmHg after drug treatment) ;
• Subclavian artery stenosis≥50% or subclavian steal syndrome;
• Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;
• 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);
• Any contraindication for magnetic resonance imaging: metal implants, claustrophobia, 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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Xuanwu Hospital, BeijingOTHER

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