Effects of RIC on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude
- Conditions
- Adult
- Interventions
- Device: RICDevice: sham RIC
- Registration Number
- NCT03728114
- Lead Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Altitude RIC group RIC Thirty young healthy males from the altitude of 3700 meters will be allocated to the High Altitude RIC group. They will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. The treatment was carried out using an electric auto-control device (patent number ZL200820123637.X, China) Low Altitude Sham group sham RIC Thirty young healthy males from the altitude of 42 meters will be allocated to the Low Altitude Sham group. They 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, performed twice a day for a total of 7 days. High Altitude Sham group sham RIC Thirty young healthy males from the altitude of 3700 meters will be allocated to the High Altitude Sham group. They 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, performed twice a day for a total of 7 days. Low Altitude RIC group RIC Thirty young healthy males from the altitude of 42 meters will be allocated to the Low Altitude RIC group. They will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs, performed twice a day for a total of 7 days. The treatment was carried out using an electric auto-control device.
- Primary Outcome Measures
Name Time Method Attentional network test change from baseline (pre-RIC treatment) at 7days after RIC treatment 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.
- Secondary Outcome Measures
Name Time Method The peak systolic blood flow velocity (PSV) of bilateral middle cerebral artery (MCA) change from baseline(pre-RIC treatment) at 7days after RIC treatment This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
end-diastolic blood flow velocity (EDV) of bilateral middle cerebral artery (MCA) change from baseline(pre-RIC treatment) at 7days after RIC treatment This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator within 7 days after RIC treatment it is an aspect which can reflect the safety of remote ischemic conditioning
basic fibroblast growth factor change from baseline (pre-RIC treatment) at 7 days after RIC treatment basic fibroblast growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.
heart rate change from baseline(pre-RIC treatment) at 7days after RIC treatment the heart rate will be measured by automatic blood pressure monitor
blood oxygen saturation (SaO2) change from baseline(pre-RIC treatment) at 7days after RIC treatment The portable oxygen saturation ward apparatus (Datex -Ohmeda, USA) will be used to monitor the blood oxygen saturation (SaO2)
platelet derived growth factor change from baseline (pre-RIC treatment) at 7 days after RIC treatment platelet derived growth facto will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.
the rate of Adverse event change from baseline (pre-RIC treatment) at 7 days after RIC treatment Any adverse event will be reported and its relationship with the RIC intervention will be evaluated.
distal radial pulses within 7 days after RIC treatment It is an aspect which can reflect the safety of remote ischemic conditioning
the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure within 7 days after RIC treatment it is an aspect which can reflect the safety of remote ischemic conditioning
blood pressure change from baseline(pre-RIC treatment) at 7days after RIC treatment Both systolic, and diastolic pressure will be measured by automatic blood pressure monitor
the mean flow velocity (MFV) of the subjects' bilateral middle cerebral artery (MCA) change from baseline (pre-RIC treatment) at 7 days after RIC treatment This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
The degree of palpation of tenderness--visual analogue scale within 7 days after RIC treatment The degree of palpation of tenderness is an aspect which can reflect the safety of remote ischemic conditioning. The pain was assessed with visual analogue scale ( VAS)
the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator. within 7 days after RIC treatment it is an aspect which can reflect the safety of remote ischemic conditioning
pulse index (PI) of the subjects' bilateral middle cerebral artery (MCA) change from baseline (pre-RIC treatment) at 7 days after RIC treatment This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards
vascular endothelial growth factor change from baseline (pre-RIC treatment) at 7 days after RIC treatment vascular endothelial growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.
the number of erythema in the skin within 7 days after RIC treatment It is an aspect which can reflect the safety of remote ischemic conditioning
cerebral oxygen saturation(TOI) change from baseline(pre-RIC treatment) at 7days after RIC treatment The cerebral oxygen monitor (EGOS-600, Jiangsu China) will be used to monitor the cerebral oxygen saturation (TOI).