- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022149
Remote Ischemic Preconditioning for Subcortical Vascular Dementia (RIPSVD)
January 12, 2017 updated by: Junwei Hao, Tianjin Medical University General Hospital
The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tianjin
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Tianjin, Tianjin, China, 300000
- Tianjin Medical University General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Doctormate® (200mmHg)
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months
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Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
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Sham Comparator: Doctormate® (60mmHg)
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months
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Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive impairment assessment scale-HVLT
Time Frame: At the first day/sixth month after randomization
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Comparing two groups of participants score changes in Short-term auditory verbal memory、learning rate and learning strategies.
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At the first day/sixth month after randomization
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Cognitive impairment assessment scale-SDMT
Time Frame: At the first day/sixth month after randomization
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Comparing two groups of participants score changes in-attention.
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At the first day/sixth month after randomization
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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.
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At the first day/sixth month after randomization
|
Cognitive impairment assessment scale-ADL
Time Frame: At the first day/sixth month after randomization
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Comparing two groups of participants score changes in daily life ability.
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At the first day/sixth month after randomization
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Cognitive impairment assessment scale-TMT
Time Frame: At the first day/sixth month after randomization
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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.
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At the first day/sixth month after randomization
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Cognitive impairment assessment scale-NPI
Time Frame: At the first day/sixth month after randomization
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Comparing two groups of participants score changes in mental behavior symptoms.
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At the first day/sixth month after randomization
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Cognitive impairment assessment scale-Chinese auditory learning test
Time Frame: At the first day/sixth month after randomization
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Comparing two groups of participants score changes in speech ACTS and breadth of knowledge.
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At the first day/sixth month after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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At the fist day/sixth month after randomization
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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.
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At the fist day/sixth month after randomization
|
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.
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At the fist day/sixth month after randomization
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Serological inflammatory markers-IL - 6
Time Frame: At the fist day/sixth month after randomization
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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.
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At the fist day/sixth month after randomization
|
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.
|
At the fist day/sixth month after randomization
|
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.
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At the fist day/sixth month after randomization
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Imaging markers-Routine MRI
Time Frame: At the fist day/sixth month after randomization
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To evaluate two sets of T2 weighted white matter lesions volume (T2 weighted lesion volume, T2WLV) before and after the treatment.
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At the fist day/sixth month after randomization
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Laboratory examination of the urine routine
Time Frame: At the first month/third month after randomization
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At the first month/third month after randomization
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Laboratory examination of the blood routine
Time Frame: At the first month/third month after randomization
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At the first month/third month after randomization
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Laboratory examination of the blood coagulation function
Time Frame: At the first month/third month after randomization
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At the first month/third month after randomization
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Laboratory examination of the liver function
Time Frame: At the first month/third month after randomization
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At the first month/third month after randomization
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Laboratory examination of the kidney function
Time Frame: At the first month/third month after randomization
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At the first month/third month after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Junwei Hao, PHD, MD, Tianjin Medical University General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
December 30, 2016
First Submitted That Met QC Criteria
January 12, 2017
First Posted (Estimate)
January 16, 2017
Study Record Updates
Last Update Posted (Estimate)
January 16, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Dementia, Vascular
Other Study ID Numbers
- IRB2016-YX-042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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