Remote Ischemic Preconditioning for Subcortical Vascular Dementia

Not Applicable

• Conditions: Subcortical Vascular Dementia
• Interventions: Device: Doctormate® (60mmHg); Device: Doctormate® (200mmHg)

• Registration Number: NCT03022149
• Lead Sponsor: Tianjin Medical University General Hospital

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-12-30
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-12
• Last Update Submitted: 2017-01-12
• Study First Posted: 2017-01-16
• Last Update Posted: 2017-01-16
• Primary Completion: 2017-03
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doctormate® (60mmHg)	Doctormate® (60mmHg)	Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 6 months
Doctormate® (200mmHg)	Doctormate® (200mmHg)	Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 6 months

Primary Outcome Measures

Name	Time	Method
Cognitive impairment assessment scale-SDMT	At the first day/sixth month after randomization	Comparing two groups of participants score changes in-attention.
Cognitive impairment assessment scale-HVLT	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-TMT	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	At the first day/sixth month after randomization	Comparing two groups of participants score changes in mental behavior symptoms.
Cognitive impairment assessment scale-JLO	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	At the first day/sixth month after randomization	Comparing two groups of participants score changes in daily life ability.
Cognitive impairment assessment scale-Chinese auditory learning test	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

Name	Time	Method
Serological inflammatory markers-TNF-a	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	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-Routine MRI	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.
Serological inflammatory markers-IL - 6	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	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.
Serological inflammatory markers-hs-CRP	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	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.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China