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History of Changes for Study: NCT03022149
Remote Ischemic Preconditioning for Subcortical Vascular Dementia (RIPSVD)
Latest version (submitted January 12, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 12, 2017 None (earliest Version on record)
Comparison Format:

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Study NCT03022149
Submitted Date:  January 12, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB2016-YX-042
Brief Title: Remote Ischemic Preconditioning for Subcortical Vascular Dementia (RIPSVD)
Official Title: Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2017
Overall Status: Unknown status [Previously: Active, not recruiting]
Study Start: February 2016
Primary Completion: March 2017 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: December 30, 2016
First Submitted that
Met QC Criteria:
January 12, 2017
First Posted: January 16, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 12, 2017
Last Update Posted: January 16, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Tianjin Medical University General Hospital
Responsible Party: Principal Investigator
Investigator: Junwei Hao
Official Title: Professor
Affiliation: Tianjin Medical University General Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Subcortical Vascular Dementia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 52 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: Junwei Hao, PHD, MD
Principal Investigator
Tianjin Medical University General Hospital
Locations: China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300000
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

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