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Remote Ischemic Preconditioning for Subcortical Vascular Dementia (RIPSVD)

Primary Purpose

Subcortical Vascular Dementia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Doctormate® (200mmHg)
Doctormate® (60mmHg)
Sponsored by
Tianjin Medical University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subcortical Vascular Dementia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Doctormate® (200mmHg)

Doctormate® (60mmHg)

Arm Description

Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months

Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months

Outcomes

Primary Outcome Measures

Cognitive impairment assessment scale-HVLT
Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
Cognitive impairment assessment scale-SDMT
Comparing two groups of participants score changes in-attention.
Cognitive impairment assessment scale-JLO
Comparing two groups of participants score changes in spatial perception and orientation ability.
Cognitive impairment assessment scale-ADL
Comparing two groups of participants score changes in daily life ability.
Cognitive impairment assessment scale-TMT
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
Comparing two groups of participants score changes in mental behavior symptoms.
Cognitive impairment assessment scale-Chinese auditory learning test
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.

Secondary Outcome Measures

Serological inflammatory markers-hs-CRP
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
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
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
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
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
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
To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.

Full Information

First Posted
December 30, 2016
Last Updated
January 12, 2017
Sponsor
Tianjin Medical University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03022149
Brief Title
Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Acronym
RIPSVD
Official Title
Remote Ischemic Preconditioning for Subcortical Vascular Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University General Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subcortical Vascular Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doctormate® (200mmHg)
Arm Type
Experimental
Arm Description
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months
Arm Title
Doctormate® (60mmHg)
Arm Type
Sham Comparator
Arm Description
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months
Intervention Type
Device
Intervention Name(s)
Doctormate® (200mmHg)
Intervention Description
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
Intervention Type
Device
Intervention Name(s)
Doctormate® (60mmHg)
Intervention Description
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
Primary Outcome Measure Information:
Title
Cognitive impairment assessment scale-HVLT
Description
Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
Time Frame
At the first day/sixth month after randomization
Title
Cognitive impairment assessment scale-SDMT
Description
Comparing two groups of participants score changes in-attention.
Time Frame
At the first day/sixth month after randomization
Title
Cognitive impairment assessment scale-JLO
Description
Comparing two groups of participants score changes in spatial perception and orientation ability.
Time Frame
At the first day/sixth month after randomization
Title
Cognitive impairment assessment scale-ADL
Description
Comparing two groups of participants score changes in daily life ability.
Time Frame
At the first day/sixth month after randomization
Title
Cognitive impairment assessment scale-TMT
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.
Time Frame
At the first day/sixth month after randomization
Title
Cognitive impairment assessment scale-NPI
Description
Comparing two groups of participants score changes in mental behavior symptoms.
Time Frame
At the first day/sixth month after randomization
Title
Cognitive impairment assessment scale-Chinese auditory learning test
Description
Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
Time Frame
At the first day/sixth month after randomization
Secondary Outcome Measure Information:
Title
Serological inflammatory markers-hs-CRP
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.
Time Frame
At the fist day/sixth month after randomization
Title
Serological inflammatory markers-TNF-a
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.
Time Frame
At the fist day/sixth month after randomization
Title
Serological inflammatory markers-IL - 1b
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.
Time Frame
At the fist day/sixth month after randomization
Title
Serological inflammatory markers-IL - 6
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.
Time Frame
At the fist day/sixth month after randomization
Title
Serological inflammatory markers-ACT
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.
Time Frame
At the fist day/sixth month after randomization
Title
Imaging markers-DTI
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.
Time Frame
At the fist day/sixth month after randomization
Title
Imaging markers-Routine MRI
Description
To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.
Time Frame
At the fist day/sixth month after randomization
Other Pre-specified Outcome Measures:
Title
Laboratory examination of the urine routine
Time Frame
At the first month/third month after randomization
Title
Laboratory examination of the blood routine
Time Frame
At the first month/third month after randomization
Title
Laboratory examination of the blood coagulation function
Time Frame
At the first month/third month after randomization
Title
Laboratory examination of the liver function
Time Frame
At the first month/third month after randomization
Title
Laboratory examination of the kidney function
Time Frame
At the first month/third month after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of vascular dementia In three months without cerebral infarction MMSE 15 to 26 points;CDR 1-2 points;MoCA < 26 points MRI showed subcortical ischemic cerebrovascular disease. Exclusion Criteria: AD 、 FTD, DLB and other causes of dementia. Cortical/subcortical infarction Cortex watershed infarction Cerebral hemorrhage Hydrocephalus Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc. Cannot complete aphasia neuropsychological assessment. Genetic or inflammatory small vascular disease. Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease. Alcohol poisoning; Cancer Hypothyroidism Schizophrenia;Hamilton depression rating scale > 17 points. Can not complete MRI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junwei Hao, PHD, MD
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31443692
Citation
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.
Results Reference
derived

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Remote Ischemic Preconditioning for Subcortical Vascular Dementia

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