Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subcortical Vascular Dementia
- Sponsor
- Tianjin Medical University General Hospital
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Cognitive impairment assessment scale-SDMT
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.
Detailed Description
In this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52 participants aged 50-80 years. The participants had a diagnosis of subcortical vascular dementia at the neurology department of Tianjin medical university general hospital. Inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small vessel disease. All participants received standard medical management.Participants in the remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper limb ischemia followed by reperfusion. The remote ischemic precondition procedure was performed once daily over 180 consecutive days. Cognitive impairment assessment scale ( Hopkins Verbal Learning Test,HVLT;Symbol digital modalities tes,SDMT;judgement line orientation, JLO;trail making test A and B,TMT-A/B;chinese word fluency test;Activity of Daily Living Scale,ADL;Neuropsychiatric Inventory,NPI), serological inflammatory markers:hypersensitive C-reactive protein（hs-CRP）、plasma tumor necrosis factor-α(TNF-α)、interleukin-1β(IL-1β)、interleukin-6 (IL-6)、α1-antichymotrypsin),and MRI diffusion tensor imaging, DTI were compared with the untreated control group.
Investigators
Junwei Hao
Professor
Tianjin Medical University General Hospital
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of vascular dementia
- •In three months without cerebral infarction
- •MMSE 15 to 26 points;CDR 1-2 points;MoCA \< 26 points
- •MRI showed subcortical ischemic cerebrovascular disease.
Exclusion Criteria
- •AD 、 FTD, DLB and other causes of dementia.
- •Cortical/subcortical infarction
- •Cortex watershed infarction
- •Cerebral hemorrhage
- •Hydrocephalus
- •Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc.
- •Cannot complete aphasia neuropsychological assessment.
- •Genetic or inflammatory small vascular disease.
- •Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.
- •Alcohol poisoning;
Outcomes
Primary Outcomes
Cognitive impairment assessment scale-SDMT
Time Frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in-attention.
Cognitive impairment assessment scale-HVLT
Time Frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
Cognitive impairment assessment scale-TMT
Time Frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in this test.This test reflects notice, order, mental flexibility, visual search and motor function, and set transfer (set shifting), at the same time reflect the hand-eye coordination, spatial perception and pay attention to ability.
Cognitive impairment assessment scale-NPI
Time Frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in mental behavior symptoms.
Cognitive impairment assessment scale-JLO
Time Frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in spatial perception and orientation ability.
Cognitive impairment assessment scale-ADL
Time Frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in daily life ability.
Cognitive impairment assessment scale-Chinese auditory learning test
Time Frame: At the first day/sixth month after randomization
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
Secondary Outcomes
- Serological inflammatory markers-TNF-a(At the fist day/sixth month after randomization)
- Serological inflammatory markers-IL - 1b(At the fist day/sixth month after randomization)
- Imaging markers-Routine MRI(At the fist day/sixth month after randomization)
- Serological inflammatory markers-IL - 6(At the fist day/sixth month after randomization)
- Imaging markers-DTI(At the fist day/sixth month after randomization)
- Serological inflammatory markers-hs-CRP(At the fist day/sixth month after randomization)
- Serological inflammatory markers-ACT(At the fist day/sixth month after randomization)