Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patient age≥18 years;
No gender preference;
Diagnosed with acute ischemic stroke;
From onset to treatment ≤48 h;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
RIC
DeviceThe 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
DeviceThe 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: RIC groupExperimental treatment 1 intervention
Group B: Sham-RIC groupSham comparator 1 intervention
Trial outcomes
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).
Time frame
Day 14Secondary outcomes
1
Cumulative incidence of post-stroke depression
The cumulative incidence of post-stroke depression is calculated as (number of post-stroke depression cases during follow-up / total enrolled participants) × 100%.
Time frame
Day 28, Day 90, and Day 1802
Incidence of post-stroke anxiety
The diagnosis of post-stroke anxiety is established according to the "Anxiety 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).
Time frame
Day 1803
Cumulative incidence of post-stroke anxiety state
Post-stroke anxiety state is defined as a 14-item Hamilton Anxiety Rating Scale (HAMA-14) score ≥7 points.
Time frame
Day 14, Day 28, Day 90, and Day 1804
Change from baseline in enlarged perivascular spaces (EPVS) severity score (range 0-4)
EPVS in the basal ganglia (BG) and centrum semiovale (CSO) are visually scored as: 0 = none, 1 = 1-10, 2 = 11-20, 3 = 21-40, and 4 = \>40 on the axial slice with the highest burden and hemicerebrum with higher burden. The higher the score, the worse the outcome.
Time frame
Day 14Other outcomes
1
Incidence of adverse events
Adverse events include dizziness, headache, palpitation, and subcutaneous ecchymosis and swelling at the intervention site.
Time frame
Day 14, Day 28, Day 90, and Day 1802
Incidence of serious adverse events
Serious adverse events include death, life-threatening illness or injury, hospitalization or prolonged hospitalization, medical or surgical intervention required to prevent permanent injury, severe disability, or incompetence, and other serious medical events.
Time frame
Day 14, Day 28, Day 90, and Day 180Sponsors and contacts
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Source ClinicalTrials.gov
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