Status:
NOT_YET_RECRUITING
Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Post-stroke Depression
Remote Ischemic Conditioning
Eligibility:
All Genders
18+ years
Phase:
NA
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% ...
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...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06920706
Start Date
April 10 2025
End Date
December 31 2026
Last Update
April 10 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Tongren City People's Hospital
Tongren, Guizhou, China, 554399
2
Baoding People's Hospital
Baoding, Hebei, China, 071030
3
Jilin People's Hospital
Jilin, Jilin, China, 132001
4
Jincheng People's Hospital
Jincheng, Shanxi, China, 048028