The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Cognitive impairment assessment scale-HVLT
Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
Time frame: At the first day/sixth month after randomization
Cognitive impairment assessment scale-SDMT
Comparing two groups of participants score changes in-attention.
Time frame: At the first day/sixth month after randomization
Cognitive impairment assessment scale-JLO
Comparing two groups of participants score changes in spatial perception and orientation ability.
Time frame: At the first day/sixth month after randomization
Cognitive impairment assessment scale-ADL
Comparing two groups of participants score changes in daily life ability.
Time frame: At the first day/sixth month after randomization
Cognitive impairment assessment scale-TMT
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.
Time frame: At the first day/sixth month after randomization
Cognitive impairment assessment scale-NPI
Comparing two groups of participants score changes in mental behavior symptoms.
Time frame: At the first day/sixth month after randomization
Cognitive impairment assessment scale-Chinese auditory learning test
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
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Time frame: At the first day/sixth month after randomization
Serological inflammatory markers-hs-CRP
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-TNF-a
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-IL - 1b
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-IL - 6
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Time frame: At the fist day/sixth month after randomization
Serological inflammatory markers-ACT
Collecte venous blood from two groups of paticipants at the first day/sixth month,detect the inflammatory factors by ELISA and compare the changes between the two groups.
Time frame: At the fist day/sixth month after randomization
Imaging markers-DTI
To evaluate two groups of whole brain white matter (whole brain white matter, WBWM) and apparent normal white matter (normal appearing white matter, NAWM) difference of MD and FA before and after the treatment , to evaluate whether the treatment group more helpful to improve the neural axon damage.
Time frame: At the fist day/sixth month after randomization
Imaging markers-Routine MRI
To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.
Time frame: At the fist day/sixth month after randomization