Remote Ischemic Preconditioning for Subcortical Vascular Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.

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Detailed Description

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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.

Conditions

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Subcortical Vascular Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Doctormate® (200mmHg)

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

Group Type EXPERIMENTAL

Doctormate® (200mmHg)

Intervention Type DEVICE

Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.

Doctormate® (60mmHg)

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

Group Type SHAM_COMPARATOR

Doctormate® (60mmHg)

Intervention Type DEVICE

Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.

Interventions

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Doctormate® (200mmHg)

Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.

Intervention Type DEVICE

Doctormate® (60mmHg)

Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No