Remote Ischemic Preconditioning for Subcortical Vascular Dementia (RIPSVD)

Tianjin Medical University

Status: Unknown

Conditions: Subcortical Vascular Dementia

Treatments: Device: Doctormate® (60mmHg); Device: Doctormate® (200mmHg)

Study type: Interventional

Funder types: Other

Identifiers

NCT03022149

IRB2016-YX-042

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

52 participants in 2 patient groups

Doctormate® (200mmHg)

Experimental group

Description:

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

Treatment:

Device: Doctormate® (200mmHg)

Doctormate® (60mmHg)

Sham Comparator group

Description:

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

Treatment:

Device: Doctormate® (60mmHg)