Effects of RIC on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude

Affiliated Hospital to Academy of Military Medical Sciences120 enrolled

Overview

Several studies have shown cognitive impairment such as memory, perception and learning skill during ascent to high altitudes. However, few studies have directly investigated the effect of high altitudes exposure on attention-a high-level cognitive function. Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, It has been proven to be an effective strategy for neuroprotection in ischemic stroke and chronic cerebral ischemia patients.

This study will provide insights into the preliminary proof of principle, safety, cognitive dysfunction and blood oxygen levels protective effects of RIC in Adults Exposing to High Altitude Conditions, and this data will provide parameters for future larger scale clinical trials if efficacious.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Adult

Interventions

RICDEVICE

Adults allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.

sham RICDEVICE

Adults allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The age was between 19 and 30 years. * All participants should meet the criteria which included right-hand dominance, normal or corrected-to-normal vision. * the RIC group volunteers have no history of intravascular thrombosis in the bilateral upper limbs; * The high altitude participants move into the high-altitude environment within one month, and the low altitude volunteers have long-term life in low altitude areas. Exclusion Criteria: * Severe hepatic or renal dysfunction * Severe hemostatic disorder or severe coagulation dysfunction * Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation * Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year * Patient participating in a study involving other drug or device trial study 7. Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations 8. Unlikely to be available for follow-up for 3 months 9. Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Outcomes

Primary Outcomes

Attentional network test

The computer software attentional network test (ANT) as described by Fan et al. in 2002 will be used to measuring the Orienting function, executive function and alerting function.

Time frame: change from baseline (pre-RIC treatment) at 7days after RIC treatment

Secondary Outcomes

basic fibroblast growth factor

basic fibroblast growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.

Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment

platelet derived growth factor

platelet derived growth facto will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.

Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment

vascular endothelial growth factor

vascular endothelial growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.

Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment

the rate of Adverse event

Any adverse event will be reported and its relationship with the RIC intervention will be evaluated.

Time frame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment

distal radial pulses

It is an aspect which can reflect the safety of remote ischemic conditioning

Time frame: within 7 days after RIC treatment

the number of erythema in the skin

Central Contacts

Lian Duan, MD PHD

CONTACT

861013911365592 duanlian307@sina.com

Han Cong, MD MS

CONTACT

861013466346163 hc82225@126.com

Data from ClinicalTrials.gov

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