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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

Tracking Information
First Submitted Date  ICMJE December 30, 2016
First Posted Date  ICMJE January 16, 2017
Last Update Posted Date January 16, 2017
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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 score changes in mental behavior symptoms.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 12, 2017)
  • Laboratory examination of the urine routine [ Time Frame: At the first month/third month after randomization ]
  • Laboratory examination of the blood routine [ Time Frame: At the first month/third month after randomization ]
  • Laboratory examination of the blood coagulation function [ Time Frame: At the first month/third month after randomization ]
  • Laboratory examination of the liver function [ Time Frame: At the first month/third month after randomization ]
  • Laboratory examination of the kidney function [ Time Frame: At the first month/third month after randomization ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Subcortical Vascular Dementia
Intervention  ICMJE
  • Device: Doctormate® (200mmHg)
    Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
  • Device: Doctormate® (60mmHg)
    Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
Study Arms  ICMJE
  • Experimental: Doctormate® (200mmHg)
    Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months
    Intervention: Device: Doctormate® (200mmHg)
  • Sham Comparator: Doctormate® (60mmHg)
    Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months
    Intervention: Device: Doctormate® (60mmHg)
Publications * Liao Z, Bu Y, Li M, Han R, Zhang N, Hao J, Jiang W. Remote ischemic conditioning improves cognition in patients with subcortical ischemic vascular dementia. BMC Neurol. 2019 Aug 23;19(1):206. doi: 10.1186/s12883-019-1435-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 12, 2017)
52
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03022149
Other Study ID Numbers  ICMJE IRB2016-YX-042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Junwei Hao, Tianjin Medical University General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tianjin Medical University General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Junwei Hao, PHD, MD Tianjin Medical University General Hospital
PRS Account Tianjin Medical University General Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP