<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03022149</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2016-YX-042</org_study_id>
    <nct_id>NCT03022149</nct_id>
  </id_info>
  <brief_title>Remote Ischemic Preconditioning for Subcortical Vascular Dementia</brief_title>
  <acronym>RIPSVD</acronym>
  <official_title>Remote Ischemic Preconditioning for Subcortical Vascular Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the remote ischemic preconditioning are&#xD;
      effective in the treatment of mild to moderate vascular dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52&#xD;
      participants aged 50-80 years. The participants had a diagnosis of subcortical vascular&#xD;
      dementia at the neurology department of Tianjin medical university general hospital.&#xD;
      Inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination&#xD;
      score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small&#xD;
      vessel disease. All participants received standard medical management.Participants in the&#xD;
      remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper&#xD;
      limb ischemia followed by reperfusion. The remote ischemic precondition procedure was&#xD;
      performed once daily over 180 consecutive days. Cognitive impairment assessment scale (&#xD;
      Hopkins Verbal Learning Test,HVLT;Symbol digital modalities tes,SDMT;judgement line&#xD;
      orientation, JLO;trail making test A and B,TMT-A/B;chinese word fluency test;Activity of&#xD;
      Daily Living Scale,ADL;Neuropsychiatric Inventory,NPI), serological inflammatory&#xD;
      markers:hypersensitive C-reactive protein（hs-CRP）、plasma tumor necrosis&#xD;
      factor-α(TNF-α)、interleukin-1β(IL-1β)、interleukin-6 (IL-6)、α1-antichymotrypsin),and MRI&#xD;
      diffusion tensor imaging, DTI were compared with the untreated control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive impairment assessment scale-HVLT</measure>
    <time_frame>At the first day/sixth month after randomization</time_frame>
    <description>Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive impairment assessment scale-SDMT</measure>
    <time_frame>At the first day/sixth month after randomization</time_frame>
    <description>Comparing two groups of participants score changes in-attention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive impairment assessment scale-JLO</measure>
    <time_frame>At the first day/sixth month after randomization</time_frame>
    <description>Comparing two groups of participants score changes in spatial perception and orientation ability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive impairment assessment scale-ADL</measure>
    <time_frame>At the first day/sixth month after randomization</time_frame>
    <description>Comparing two groups of participants score changes in daily life ability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive impairment assessment scale-TMT</measure>
    <time_frame>At the first day/sixth month after randomization</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive impairment assessment scale-NPI</measure>
    <time_frame>At the first day/sixth month after randomization</time_frame>
    <description>Comparing two groups of participants score changes in mental behavior symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive impairment assessment scale-Chinese auditory learning test</measure>
    <time_frame>At the first day/sixth month after randomization</time_frame>
    <description>Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serological inflammatory markers-hs-CRP</measure>
    <time_frame>At the fist day/sixth month after randomization</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serological inflammatory markers-TNF-a</measure>
    <time_frame>At the fist day/sixth month after randomization</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serological inflammatory markers-IL - 1b</measure>
    <time_frame>At the fist day/sixth month after randomization</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serological inflammatory markers-IL - 6</measure>
    <time_frame>At the fist day/sixth month after randomization</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serological inflammatory markers-ACT</measure>
    <time_frame>At the fist day/sixth month after randomization</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Imaging markers-DTI</measure>
    <time_frame>At the fist day/sixth month after randomization</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Imaging markers-Routine MRI</measure>
    <time_frame>At the fist day/sixth month after randomization</time_frame>
    <description>To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Laboratory examination of the urine routine</measure>
    <time_frame>At the first month/third month after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Laboratory examination of the blood routine</measure>
    <time_frame>At the first month/third month after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Laboratory examination of the blood coagulation function</measure>
    <time_frame>At the first month/third month after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Laboratory examination of the liver function</measure>
    <time_frame>At the first month/third month after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Laboratory examination of the kidney function</measure>
    <time_frame>At the first month/third month after randomization</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Subcortical Vascular Dementia</condition>
  <arm_group>
    <arm_group_label>Doctormate® (200mmHg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Doctormate® (60mmHg)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doctormate® (200mmHg)</intervention_name>
    <description>Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.</description>
    <arm_group_label>Doctormate® (200mmHg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doctormate® (60mmHg)</intervention_name>
    <description>Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.</description>
    <arm_group_label>Doctormate® (60mmHg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of vascular dementia&#xD;
&#xD;
          2. In three months without cerebral infarction&#xD;
&#xD;
          3. MMSE 15 to 26 points;CDR 1-2 points;MoCA &lt; 26 points&#xD;
&#xD;
          4. MRI showed subcortical ischemic cerebrovascular disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. AD 、 FTD, DLB and other causes of dementia.&#xD;
&#xD;
          2. Cortical/subcortical infarction&#xD;
&#xD;
          3. Cortex watershed infarction&#xD;
&#xD;
          4. Cerebral hemorrhage&#xD;
&#xD;
          5. Hydrocephalus&#xD;
&#xD;
          6. Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis,&#xD;
             radiation encephalopathy, etc.&#xD;
&#xD;
          7. Cannot complete aphasia neuropsychological assessment.&#xD;
&#xD;
          8. Genetic or inflammatory small vascular disease.&#xD;
&#xD;
          9. Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.&#xD;
&#xD;
         10. Alcohol poisoning;&#xD;
&#xD;
         11. Cancer&#xD;
&#xD;
         12. Hypothyroidism&#xD;
&#xD;
         13. Schizophrenia;Hamilton depression rating scale &gt; 17 points.&#xD;
&#xD;
         14. Can not complete MRI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junwei Hao, PHD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Medical University General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin Medical University General Hospital</investigator_affiliation>
    <investigator_full_name>Junwei Hao</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Dementia, Vascular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022149
org study id: IRB2016-YX-042
nct id: NCT03022149
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Cognitive impairment assessment scale-HVLT
time frame: At the first day/sixth month after randomization
description: Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
measure: Cognitive impairment assessment scale-SDMT
time frame: At the first day/sixth month after randomization
description: Comparing two groups of participants score changes in-attention.
measure: Cognitive impairment assessment scale-JLO
time frame: At the first day/sixth month after randomization
description: Comparing two groups of participants score changes in spatial perception and orientation ability.
measure: Cognitive impairment assessment scale-ADL
time frame: At the first day/sixth month after randomization
description: Comparing two groups of participants score changes in daily life ability.
measure: Cognitive impairment assessment scale-TMT
time frame: At the first day/sixth month after randomization
description: 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.
measure: Cognitive impairment assessment scale-NPI
time frame: At the first day/sixth month after randomization
description: Comparing two groups of participants score changes in mental behavior symptoms.
measure: Cognitive impairment assessment scale-Chinese auditory learning test
time frame: At the first day/sixth month after randomization
description: Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
measure: Serological inflammatory markers-hs-CRP
time frame: At the fist day/sixth month after randomization
description: 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.
measure: Serological inflammatory markers-TNF-a
time frame: At the fist day/sixth month after randomization
description: 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.
measure: Serological inflammatory markers-IL - 1b
time frame: At the fist day/sixth month after randomization
description: 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.
measure: Serological inflammatory markers-IL - 6
time frame: At the fist day/sixth month after randomization
description: 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.
measure: Serological inflammatory markers-ACT
time frame: At the fist day/sixth month after randomization
description: 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.
measure: Imaging markers-DTI
time frame: At the fist day/sixth month after randomization
description: 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.
measure: Imaging markers-Routine MRI
time frame: At the fist day/sixth month after randomization
description: To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.
measure: Laboratory examination of the urine routine
time frame: At the first month/third month after randomization
measure: Laboratory examination of the blood routine
time frame: At the first month/third month after randomization
measure: Laboratory examination of the blood coagulation function
time frame: At the first month/third month after randomization
measure: Laboratory examination of the liver function
time frame: At the first month/third month after randomization
measure: Laboratory examination of the kidney function
time frame: At the first month/third month after randomization
arm group label: Doctormate® (200mmHg)
arm group type: Experimental
description: Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months
arm group label: Doctormate® (60mmHg)
arm group type: Sham Comparator
description: Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months
intervention type: Device
intervention name: Doctormate® (200mmHg)
description: Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
arm group label: Doctormate® (200mmHg)
intervention type: Device
intervention name: Doctormate® (60mmHg)
description: Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
arm group label: Doctormate® (60mmHg)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Junwei Hao, PHD, MD
role: Principal Investigator
affiliation: Tianjin Medical University General Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin Medical University General Hospital
investigator full name: Junwei Hao
investigator title: Professor
mesh term: Dementia
mesh term: Dementia, Vascular
sharing ipd: Undecided