Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT06920706
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-10
First Post:
2025-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Day 14, Day 28, Day 90, and Day 180', 'description': 'Adverse events include dizziness, headache, palpitation, and subcutaneous ecchymosis and swelling at the intervention site.'}, {'measure': 'Incidence of serious adverse events', 'timeFrame': 'Day 14, Day 28, Day 90, and Day 180', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Incidence of post-stroke depression', 'timeFrame': 'Day 14', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of post-stroke depression', 'timeFrame': 'Day 28, Day 90, and Day 180', 'description': 'The cumulative incidence of post-stroke depression is calculated as (number of post-stroke depression cases during follow-up / total enrolled participants) × 100%.'}, {'measure': 'Incidence of post-stroke anxiety', 'timeFrame': 'Day 180', 'description': '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).'}, {'measure': 'Cumulative incidence of post-stroke anxiety state', 'timeFrame': 'Day 14, Day 28, Day 90, and Day 180', 'description': 'Post-stroke anxiety state is defined as a 14-item Hamilton Anxiety Rating Scale (HAMA-14) score ≥7 points.'}, {'measure': 'Change from baseline in enlarged perivascular spaces (EPVS) severity score (range 0-4)', 'timeFrame': 'Day 14', 'description': '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.'}, {'measure': 'Change from baseline in Diffusion Tensor Imaging-Analysis along the Perivascular Space (DTI-ALPS) index.', 'timeFrame': 'Day 14', 'description': 'The DTI-ALPS index is calculated as the ratio of projection-to-association fiber diffusivity in the lateral ventricular region.'}, {'measure': 'Change from baseline in Neurotransmitter levels in brain regions', 'timeFrame': 'Day 14', 'description': '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.'}, {'measure': 'Change from baseline in peripheral blood neurotransmitter levels', 'timeFrame': 'Day 14', 'description': '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).'}, {'measure': 'Change from baseline in peripheral blood cytokine levels', 'timeFrame': 'Day 14', 'description': '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).'}, {'measure': 'Change from baseline in 24-item Hamilton Depression Rating Scale (HAMD-24) score (range 0-76)', 'timeFrame': 'Day 14, Day 28, Day 90, and Day 180', 'description': 'The HAMD-24 is a standardized, clinician-rated instrument for quantifying depression severity, where elevated scores correlate with increased symptom burden.'}, {'measure': 'Change from baseline in 14-item Hamilton Anxiety Rating Scale (HAMA-14) score (range 0-56)', 'timeFrame': 'Day 14, Day 28, Day 90, and Day 180', 'description': 'The HAMA-14 is a standardized, clinician-rated instrument for quantifying anxiety severity, with higher scores indicating greater severity.'}, {'measure': 'Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score (range 0-21)', 'timeFrame': 'Day 14, Day 28, Day 90, and Day 180', 'description': 'The PSQI is a validated self-reported questionnaire assessing sleep quality and disturbances over a 1-month period. Higher scores indicate worse sleep quality.'}, {'measure': 'Change from baseline in Fugl-Meyer Assessment (FMA) score (range 0-226)', 'timeFrame': 'Day 14', 'description': 'The FMA is administered to evaluate sensorimotor recovery post-stroke. Higher total scores indicate better functional recovery.'}, {'measure': 'Change from baseline in National Institutes of Health Stroke Scale (NIHSS) score (range 0-42)', 'timeFrame': 'Day 14', 'description': 'The NIHSS is assessed to quantify neurological deficit severity. Higher scores indicate more severe impairment.'}, {'measure': 'Change from baseline in Mini-Mental State Examination (MMSE) score (range 0-30)', 'timeFrame': 'Day 90 and Day 180', 'description': 'The MMSE is administered to assess global cognitive function, with lower scores indicating greater impairment.'}, {'measure': 'Change from baseline in EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) score (range 5-25)', 'timeFrame': 'Day 90 and Day 180', 'description': 'The EQ-5D-5L is administered to assess health-related quality of life. Higher scores indicate worse quality of life.'}, {'measure': 'Change from baseline in EuroQol 5-Dimension 5-Level questionnaire Visual Analogue Scale (EQ-5D-5L VAS) score (range 0-100)', 'timeFrame': 'Day 90 and Day 180', 'description': 'The EQ-5D-5L VAS records self-rated overall health status on a vertical scale, with higher scores indicating better perceived health.'}, {'measure': 'The proportion of modified Rankin Scale (mRS) Score 0-2', 'timeFrame': 'Day 90 and Day 180', 'description': '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).'}, {'measure': 'The distribution of modified Rankin Scale (mRS) Score (range 0-6)', 'timeFrame': 'Day 90 and Day 180', 'description': 'The mRS is administered to evaluate global functional outcomes after stroke, with higher scores indicating worse outcome.'}, {'measure': 'All-cause mortality', 'timeFrame': 'Day 180', 'description': 'All-cause mortality is defined as death from any cause occurring during the study period.'}, {'measure': 'Total hospitalization time', 'timeFrame': 'Day 180', 'description': 'Total hospitalization time is calculated by summing all inpatient days across neurology and rehabilitation departments within the follow-up period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-stroke Depression', 'Remote Ischemic Conditioning']}, 'descriptionModule': {'briefSummary': '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.\n\nClinical 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.\n\nRemote 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age≥18 years;\n* No gender preference;\n* Diagnosed with acute ischemic stroke;\n* From onset to treatment ≤48 h;\n* 6≤ NIHSS scores ≤25;\n* Premorbid mRS ≤1;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Baseline HAMD-24 scores ≥8;\n* Infarction area overlapped with the area where the DTI-ALPS index is calculated;\n* A history of severe mental illness such as depression, bipolar disorder, and schizophrenia;\n* A history of mental disorders caused by other organic diseases, such as post-Parkinson depression;\n* Participants with cognitive impairment, disturbance of consciousness, severe hearing impairment, or aphasia who were unable to cooperate with the assessment;\n* 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;\n* Intracranial tumor, arteriovenous malformation, or aneurysm;\n* Uncontrolled severe hypertension (systolic pressure \\>180mmHg or diastolic pressure \\>110 mmHg after drug treatment) ;\n* Subclavian artery stenosis≥50% or subclavian steal syndrome;\n* Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;\n* 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);\n* Any contraindication for magnetic resonance imaging: metal implants, claustrophobia, etc.;\n* Women known to be pregnant or lactating, or have a positive pregnancy test;\n* Participating in other clinical trials within three months;\n* Participants not suitable for this clinical studies considered by researcher.'}, 'identificationModule': {'nctId': 'NCT06920706', 'briefTitle': 'Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'LYS[2025]039-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIC group', 'description': 'Subjects in the RIC group receive standard therapy and RIC treatment.', 'interventionNames': ['Device: RIC']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham-RIC group', 'description': 'Subjects in the Sham-RIC group receive standard therapy and Sham-RIC treatment.', 'interventionNames': ['Device: Sham-RIC']}], 'interventions': [{'name': 'RIC', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['RIC group']}, {'name': 'Sham-RIC', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Sham-RIC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '554399', 'city': 'Tongren', 'state': 'Guizhou', 'country': 'China', 'contacts': [{'name': 'Long Liao', 'role': 'CONTACT', 'phone': '+8615121644332'}], 'facility': "Tongren City People's Hospital", 'geoPoint': {'lat': 27.71722, 'lon': 109.18528}}, {'zip': '071030', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Lan Hou', 'role': 'CONTACT', 'phone': '+8613931239934'}], 'facility': "Baoding People's Hospital", 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '132001', 'city': 'Jilin', 'state': 'Jilin', 'country': 'China', 'contacts': [{'name': 'Zhifei Wang', 'role': 'CONTACT', 'phone': '+8618104421807'}], 'facility': "Jilin People's Hospital", 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'zip': '048028', 'city': 'Jincheng', 'state': 'Shanxi', 'country': 'China', 'contacts': [{'name': 'Lina Xu', 'role': 'CONTACT', 'phone': '+8613835628289'}], 'facility': "Jincheng People's Hospital", 'geoPoint': {'lat': 35.50222, 'lon': 112.83278}}, {'zip': '100053', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Lina Jia', 'role': 'CONTACT', 'email': 'lnjia@ccmu.edu.cn', 'phone': '+8615901588600'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lina Jia', 'role': 'CONTACT', 'email': 'lnjia@ccmu.edu.cn', 'phone': '+8615901588600'}, {'name': 'Shuling Wan', 'role': 'CONTACT', 'email': '15901589718@163.com', 'phone': '+8615901589718'}], 'overallOfficials': [{'name': 'Lina Jia', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}