Remote Ischemic Conditioning for Cognitive Impairment in Cerebral Small Vessel Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorJiangsu Province Nanjing Brain Hospital
About this trial
This randomized, double-blind, sham-controlled trial aims to evaluate the effect of remote ischemic conditioning (RIC) on cognitive function in patients with cerebral small vessel disease-related mild cognitive impairment. Forty eligible participants will be randomized 1:1 to receive either RIC or sham RIC twice daily for 90 days in addition to standard medical therapy. The primary outcome is the change in Montreal Cognitive Assessment (MoCA) score from baseline to 90 days. Secondary outcomes include changes in white matter hyperintensity burden and diffusion tensor imaging metrics on MRI, EEG functional connectivity, and activities of daily living.
Eligibility criteria
Qualifiers
Age 30-80 years.
Diagnosis of cerebral small vessel disease according to the Chinese Guidelines for the Diagnosis and Treatment of Cerebral Small Vessel Disease (2020).
Mild cognitive impairment with a Montreal Cognitive Assessment (MoCA) score of 18-25.
The patient or a legally authorized representative is able and willing to sign written informed consent.
Disqualifiers
Any condition that is unsuitable for remote ischemic conditioning, including soft tissue injury, limb deformity or vascular injury in the upper limb, bleeding disorders, or systolic blood pressure > 200 mmHg.
History or presence of neurological or psychiatric disorders that may interfere with participation or outcome assessment, such as other cerebrovascular diseases, Parkinson's disease, or major depressive disorder.
Current or past severe systemic diseases deemed inappropriate for the study by the investigator, including but not limited to severe cardiovascular diseases (e.g., congestive heart failure, severe arrhythmia, myocardial infarction), severe hepatic diseases (e.g., cirrhosis), severe renal diseases (e.g., requiring hemodialysis or peritoneal dialysis), hematologic diseases with bleeding tendency (e.g., hemophilia), poorly controlled diabetes (blood glucose > 16.8 mmol/L or < 2.8 mmol/L) or with severe complications, active or uncontrolled systemic autoimmune diseases or primary/secondary immunodeficiency, or malignancy.
Laboratory abnormalities, including absolute neutrophil count < 1.5 × 10⁹/L, platelet count < 100 × 10⁹/L, hemoglobin < 90 g/L, AST or ALT > 2.5 × upper limit of normal (ULN), total bilirubin > 1.5 × ULN, or serum creatinine > 1.5 × ULN.
Trial design
Treatments tested in this trial
- Remote ischemic conditioning using IPC-906 device
- Sham remote ischemic conditioning using IPC-906 device
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov