Post-stroke DepressionNCT06920706
Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression
A study testing RIC in people with Post-stroke Depression and Remote Ischemic Conditioning, run by Xuanwu Hospital, Beijing at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Depression, Remote Ischemic Conditioning
- What is being tested?
- RIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- 10 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Baoding People's Hospital
Baoding, Hebei, 071030
Lan Hou, +8613931239934
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Lina Jia, +8615901588600, lnjia@ccmu.edu.cn
Jilin People's Hospital
Jilin City, Jilin, 132001
Zhifei Wang, +8618104421807
Jincheng People's Hospital
Jincheng, Shanxi, 048028
Lina Xu, +8613835628289
Tongren City People's Hospital
Tongren, Guizhou, 554399
Long Liao, +8615121644332
About this study
Official title: Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical 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.
Read the 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 (1:1) to receive either remote ischemic conditioning (RIC) or sham-RIC treatment for 14 consecutive days. The primary outcome is the incidence of post-stroke depression at day 14 post-randomization.
- Being tested
- RIC, Sham-RIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICDevice
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.
Sham-RICDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | Subjects in the RIC group receive standard therapy and RIC treatment. Receives: Device: RIC |
| Sham-RIC group | Sham comparator | Subjects in the Sham-RIC group receive standard therapy and Sham-RIC treatment. Receives: Device: Sham-RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 14
Secondary outcomes (20)
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%.
Measured: Day 28, Day 90, and Day 180
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).
Measured: Day 180
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.
Measured: Day 14, Day 28, Day 90, and Day 180
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.
Measured: Day 14
Change from baseline in Diffusion Tensor Imaging-Analysis along the Perivascular Space (DTI-ALPS) index.
The DTI-ALPS index is calculated as the ratio of projection-to-association fiber diffusivity in the lateral ventricular region.
Measured: Day 14
Change from baseline in Neurotransmitter levels in brain regions
Proton magnetic resonance spectroscopy (¹H-MRS) is performed to quantify the levels of N-acetylaspartate (NAA), glutamate/glutamine (Glx), choline (Cho), and creatine (Cr) in the following brain regions: thalamus, caudate nucleus, putamen, globus pallidus, amygdala, hippocampus, insular cortex, medial prefrontal cortex, and cingulate cortex.
Measured: Day 14
Change from baseline in peripheral blood neurotransmitter levels
Levels of γ-aminobutyric acid (GABA), glutamate (Glu), glutamine (Gln), serotonin (5-HT), norepinephrine (NE), and dopamine (DA) in peripheral blood are measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Measured: Day 14
Change from baseline in peripheral blood cytokine levels
Levels of interleukin (IL)-1β, IL-6, IL-10, IL-15, tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), and transforming growth factor-β (TGF-β) in peripheral blood are measured using enzyme-linked immunosorbent assay (ELISA).
Measured: Day 14
Change from baseline in 24-item Hamilton Depression Rating Scale (HAMD-24) score (range 0-76)
The HAMD-24 is a standardized, clinician-rated instrument for quantifying depression severity, where elevated scores correlate with increased symptom burden.
Measured: Day 14, Day 28, Day 90, and Day 180
Change from baseline in 14-item Hamilton Anxiety Rating Scale (HAMA-14) score (range 0-56)
The HAMA-14 is a standardized, clinician-rated instrument for quantifying anxiety severity, with higher scores indicating greater severity.
Measured: Day 14, Day 28, Day 90, and Day 180
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score (range 0-21)
The PSQI is a validated self-reported questionnaire assessing sleep quality and disturbances over a 1-month period. Higher scores indicate worse sleep quality.
Measured: Day 14, Day 28, Day 90, and Day 180
Change from baseline in Fugl-Meyer Assessment (FMA) score (range 0-226)
The FMA is administered to evaluate sensorimotor recovery post-stroke. Higher total scores indicate better functional recovery.
Measured: Day 14
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) score (range 0-42)
The NIHSS is assessed to quantify neurological deficit severity. Higher scores indicate more severe impairment.
Measured: Day 14
Change from baseline in Mini-Mental State Examination (MMSE) score (range 0-30)
The MMSE is administered to assess global cognitive function, with lower scores indicating greater impairment.
Measured: Day 90 and Day 180
Change from baseline in EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) score (range 5-25)
The EQ-5D-5L is administered to assess health-related quality of life. Higher scores indicate worse quality of life.
Measured: Day 90 and Day 180
Change from baseline in EuroQol 5-Dimension 5-Level questionnaire Visual Analogue Scale (EQ-5D-5L VAS) score (range 0-100)
The EQ-5D-5L VAS records self-rated overall health status on a vertical scale, with higher scores indicating better perceived health.
Measured: Day 90 and Day 180
The proportion of modified Rankin Scale (mRS) Score 0-2
The mRS is administered to evaluate global functional outcomes after stroke, with scores ranging from 0 (no symptoms) to 6 (death). For analysis, outcomes were dichotomized as favorable (mRS 0-2) or poor (mRS 3-6).
Measured: Day 90 and Day 180
The distribution of modified Rankin Scale (mRS) Score (range 0-6)
The mRS is administered to evaluate global functional outcomes after stroke, with higher scores indicating worse outcome.
Measured: Day 90 and Day 180
All-cause mortality
All-cause mortality is defined as death from any cause occurring during the study period.
Measured: Day 180
Total hospitalization time
Total hospitalization time is calculated by summing all inpatient days across neurology and rehabilitation departments within the follow-up period.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lina Jia, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920706
- Sponsor's protocol ID
- LYS[2025]039-002
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06920706
- Acronym / sponsor ID
- LYS[2025]039-002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (1:1) to receive either remote ischemic conditioning (RIC) or sham-RIC treatment for 14 consecutive days. The primary outcome is the incidence of post-stroke depression at day 14 post-randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: RICSubjects in the RIC group receive standard therapy and RIC treatment. |
| Sham-RIC group | Sham comparator | Device: Sham-RICSubjects in the Sham-RIC group receive standard therapy and Sham-RIC treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age≥18 years;
- No gender preference;
- Diagnosed with acute ischemic stroke;
- From onset to treatment ≤48 h;
- 6≤ NIHSS scores ≤25;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RICThe 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. | Device | RIC group |
| Sham-RICThe 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. | Device | Sham-RIC group |
Primary outcome
Incidence of post-stroke depression
Time frame: Day 14
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).
20 secondary outcomes
Cumulative incidence of post-stroke depression
Time frame: Day 28, Day 90, and Day 180
Incidence of post-stroke anxiety
Time frame: Day 180
Cumulative incidence of post-stroke anxiety state
Time frame: Day 14, Day 28, Day 90, and Day 180
Change from baseline in enlarged perivascular spaces (EPVS) severity score (range 0-4)
Time frame: Day 14
Change from baseline in Diffusion Tensor Imaging-Analysis along the Perivascular Space (DTI-ALPS) index.
Time frame: Day 14
Change from baseline in Neurotransmitter levels in brain regions
Time frame: Day 14
Change from baseline in peripheral blood neurotransmitter levels
Time frame: Day 14
Change from baseline in peripheral blood cytokine levels
Time frame: Day 14
Change from baseline in 24-item Hamilton Depression Rating Scale (HAMD-24) score (range 0-76)
Time frame: Day 14, Day 28, Day 90, and Day 180
Change from baseline in 14-item Hamilton Anxiety Rating Scale (HAMA-14) score (range 0-56)
Time frame: Day 14, Day 28, Day 90, and Day 180
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score (range 0-21)
Time frame: Day 14, Day 28, Day 90, and Day 180
Change from baseline in Fugl-Meyer Assessment (FMA) score (range 0-226)
Time frame: Day 14
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) score (range 0-42)
Time frame: Day 14
Change from baseline in Mini-Mental State Examination (MMSE) score (range 0-30)
Time frame: Day 90 and Day 180
Change from baseline in EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) score (range 5-25)
Time frame: Day 90 and Day 180
Change from baseline in EuroQol 5-Dimension 5-Level questionnaire Visual Analogue Scale (EQ-5D-5L VAS) score (range 0-100)
Time frame: Day 90 and Day 180
The proportion of modified Rankin Scale (mRS) Score 0-2
Time frame: Day 90 and Day 180
The distribution of modified Rankin Scale (mRS) Score (range 0-6)
Time frame: Day 90 and Day 180
All-cause mortality
Time frame: Day 180
Total hospitalization time
Time frame: Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lina Jia study director
Xuanwu Hospital, Beijing
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC in people with Post-stroke Depression and Remote Ischemic Conditioning, run by Xuanwu Hospital, Beijing at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Jia (+8615901588600, lnjia@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-stroke depression (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.