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Remote Ischemic Preconditioning for Subcortical Vascular Dementia (RIPSVD)

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ClinicalTrials.gov Identifier: NCT03022149
Recruitment Status : Unknown
Verified January 2017 by Junwei Hao, Tianjin Medical University General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Junwei Hao, Tianjin Medical University General Hospital

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.

Condition or disease Intervention/treatment Phase
Subcortical Vascular Dementia Device: Doctormate® (200mmHg) Device: Doctormate® (60mmHg) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Study Start Date : February 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Doctormate® (200mmHg)
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months
Device: Doctormate® (200mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.

Sham Comparator: Doctormate® (60mmHg)
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months
Device: Doctormate® (60mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.




Primary Outcome Measures :
  1. 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.

  2. Cognitive impairment assessment scale-SDMT [ Time Frame: At the first day/sixth month after randomization ]
    Comparing two groups of participants score changes in-attention.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Other Outcome Measures:
  1. Laboratory examination of the urine routine [ Time Frame: At the first month/third month after randomization ]
  2. Laboratory examination of the blood routine [ Time Frame: At the first month/third month after randomization ]
  3. Laboratory examination of the blood coagulation function [ Time Frame: At the first month/third month after randomization ]
  4. Laboratory examination of the liver function [ Time Frame: At the first month/third month after randomization ]
  5. Laboratory examination of the kidney function [ Time Frame: At the first month/third month after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of vascular dementia
  2. In three months without cerebral infarction
  3. MMSE 15 to 26 points;CDR 1-2 points;MoCA < 26 points
  4. MRI showed subcortical ischemic cerebrovascular disease.

Exclusion Criteria:

  1. AD 、 FTD, DLB and other causes of dementia.
  2. Cortical/subcortical infarction
  3. Cortex watershed infarction
  4. Cerebral hemorrhage
  5. Hydrocephalus
  6. Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc.
  7. Cannot complete aphasia neuropsychological assessment.
  8. Genetic or inflammatory small vascular disease.
  9. Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.
  10. Alcohol poisoning;
  11. Cancer
  12. Hypothyroidism
  13. Schizophrenia;Hamilton depression rating scale > 17 points.
  14. Can not complete MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022149


Locations
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China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300000
Sponsors and Collaborators
Tianjin Medical University General Hospital
Investigators
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Principal Investigator: Junwei Hao, PHD, MD Tianjin Medical University General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Junwei Hao, Professor, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT03022149    
Other Study ID Numbers: IRB2016-YX-042
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases