Clinical Trial: Remote Ischemic Preconditioning for Subcortical Vascular Dementia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Remote Ischemic Preconditioning for Subcortical Vascular Dementia

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 Summary: 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.
Sponsor: Tianjin Medical University General Hospital

Current Primary Outcome:

  • 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-SDMT [ Time Frame: At the first day/sixth month after randomization ]
    Comparing two groups of participants score changes in-attention.
  • 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-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 scor

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Serological inflammatory markers-hs-CRP [ Time Frame: At the fist day/sixth month after randomization ]
      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.
    • Serological inflammatory markers-TNF-a [ Time Frame: At the fist day/sixth month after randomization ]
      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.
    • Serological inflammatory markers-IL - 1b [ Time Frame: At the fist day/sixth month after randomization ]
      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.
    • Serological inflammatory markers-IL - 6 [ Time Frame: At the fist day/sixth month after randomization ]
      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.
    • Serological inflammatory markers-ACT [ Time Frame: At the fist day/sixth month after randomization ]
      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.
    • Imaging markers-DTI [ Time Frame: At the fist day/sixth month after randomization ]
      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.
    • Imaging markers-Routine MRI [ Time Frame: At the fist day/sixth month after randomization ]
      To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.


    Original Secondary Outcome: Same as current

    Information By: Tianjin Medical University General Hospital

    Dates:
    Date Received: December 30, 2016
    Date Started: February 2016
    Date Completion: June 2017
    Last Updated: January 12, 2017
    Last Verified: January 2017