Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression

NCT06920706 | Not Yet Recruiting

• 1 other identifier: LYS[2025]039-002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

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.

Conditions

Post-stroke Depression; Remote Ischemic Conditioning

Outcome Measures

Primary Outcomes (1)

• Incidence of post-stroke depression

  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).

  Day 14

Secondary Outcomes (20)

• Cumulative incidence of post-stroke depression

  Day 28, Day 90, and Day 180

• Incidence of post-stroke anxiety

  Day 180

• Cumulative incidence of post-stroke anxiety state

  Day 14, Day 28, Day 90, and Day 180

• Change from baseline in enlarged perivascular spaces (EPVS) severity score (range 0-4)

  Day 14

• Change from baseline in Diffusion Tensor Imaging-Analysis along the Perivascular Space (DTI-ALPS) index.

  Day 14

Other Outcomes (2)

• Incidence of adverse events

  Day 14, Day 28, Day 90, and Day 180

• Incidence of serious adverse events

  Day 14, Day 28, Day 90, and Day 180

Study Arms (2)

RIC group

EXPERIMENTAL

Subjects in the RIC group receive standard therapy and RIC treatment.

Device: RIC

Sham-RIC group

SHAM COMPARATOR

Subjects in the Sham-RIC group receive standard therapy and Sham-RIC treatment.

Device: Sham-RIC

Interventions

RIC DEVICE

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.

RIC group

Sham-RIC DEVICE

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.

Sham-RIC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age≥18 years;
• No gender preference;
• Diagnosed with acute ischemic stroke;
• From onset to treatment ≤48 h;
• ≤ NIHSS scores ≤25;
• Premorbid mRS ≤1;
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (5)

Tongren City People's Hospital

Tongren, Guizhou, 554399, China

Location

Baoding People's Hospital

Baoding, Hebei, 071030, China

Location

Jilin People's Hospital

Jilin, Jilin, 132001, China

Location

Jincheng People's Hospital

Jincheng, Shanxi, 048028, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

Study Officials

• Lina Jia

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Lina Jia

CONTACT

+8615901588600; lnjia@ccmu.edu.cn

Shuling Wan

CONTACT

+8615901589718; 15901589718@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 10, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)