Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression

NCT06920706 · tracked via the Priya Life Science China tracker

Sponsor

Xuanwu Hospital, Beijing

Phase

Not applicable

Started

2025-04-10

Last updated

2025-04-10

Condition(s) studied

Post-stroke DepressionRemote Ischemic Conditioning

Investigational drug(s) / intervention(s)

RICSham-RIC

RIC: The ischemic preconditioning training device is applied to the subjects' upper arms to administer pressure (200 mmHg). The pressure is maintained for 5 minutes, followed by 5 minutes of release, completing one ischemia-reperfusion cycle. Each training session consists of 5 consecutive cycles, performed twice daily for 14 days.

Sham-RIC: The ischemic preconditioning training device is applied to the subjects' upper arms to administer pressure (60 mmHg). The pressure is maintained for 5 minutes, followed by 5 minutes of release, completing one ischemia-reperfusion cycle. Each training session consists of 5 consecutive cycles, performed twice daily for 14 days.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Incidence of post-stroke depression — Day 14
The diagnosis of post-stroke depression is established according to the "Depressive Disorder Due to Another Medical Condition" criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), using the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5-RV).

Trial sites (5)

Facility	City	Region
Tongren City People's Hospital	Tongren	Guizhou
Baoding People's Hospital	Baoding	Hebei
Jilin People's Hospital	Jilin City	Jilin
Jincheng People's Hospital	Jincheng	Shanxi
Xuanwu Hospital, Capital Medical University	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06920706 on ClinicalTrials.gov ↗ ← All trials in China