NCT06920706Not yet recruiting

Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression

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

Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 240 (estimated)
First submitted: 18 Mar 2025
Start date: 10 Apr 2025
Primary completion date: 31 Dec 2026
Lead sponsor: Xuanwu Hospital, Beijing
Diseases: Stroke
NCT number: NCT06920706

What you commit to

Study type: Interventional
Planned participants: 240
From 10 Apr 2025 to the primary completion date, 31 Dec 2026
5 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Any contraindication for magnetic resonance imaging: metal implants, claustrophobia, etc.;

Other illness

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;

Lab values

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);

Other

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.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Baoding People's Hospital Coordinator of this site? Confirm its status	Baoding	China	Unknown status
Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status	Beijing	China	Unknown status
Jilin People's Hospital Coordinator of this site? Confirm its status	Jilin City	China	Unknown status
Jincheng People's Hospital Coordinator of this site? Confirm its status	Jincheng	China	Unknown status
Tongren City People's Hospital Coordinator of this site? Confirm its status	Tongren	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.