Clinical trial NCT03728114: Effects of RIC on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude
Official title: Effects of Remote Ischemic Conditioning on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult
Keywords: adult
remote ischemic conditioning
high altitude condition
cognitive function
blood oxygen levels
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2018-11-01
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attentional network test
timeFrame: change from baseline (pre-RIC treatment) at 7days after RIC treatment
Secondary outcomes:
measure: basic fibroblast growth factor
timeFrame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
measure: platelet derived growth factor
timeFrame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
measure: vascular endothelial growth factor
timeFrame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
measure: the rate of Adverse event
timeFrame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
measure: distal radial pulses
timeFrame: within 7 days after RIC treatment
measure: the number of erythema in the skin
timeFrame: within 7 days after RIC treatment
measure: the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
timeFrame: within 7 days after RIC treatment
measure: the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator.
timeFrame: within 7 days after RIC treatment
measure: heart rate
timeFrame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
measure: blood pressure
timeFrame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
measure: blood oxygen saturation (SaO2)
timeFrame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
measure: cerebral oxygen saturation(TOI)
timeFrame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
measure: The peak systolic blood flow velocity (PSV) of bilateral middle cerebral artery (MCA)
timeFrame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
measure: end-diastolic blood flow velocity (EDV) of bilateral middle cerebral artery (MCA)
timeFrame: change from baseline(pre-RIC treatment) at 7days after RIC treatment
measure: the mean flow velocity (MFV) of the subjects' bilateral middle cerebral artery (MCA)
timeFrame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
measure: pulse index (PI) of the subjects' bilateral middle cerebral artery (MCA)
timeFrame: change from baseline (pre-RIC treatment) at 7 days after RIC treatment
measure: The degree of palpation of tenderness--visual analogue scale
timeFrame: within 7 days after RIC treatment
measure: the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator
timeFrame: within 7 days after RIC treatment
Other outcomes:
Locations:
Study officials:
affiliation: The 307th Hospital of Military Chinese People's Liberation Army
name: Lian Duan, MD PHD
role: STUDY_CHAIR
References:
citation: Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6.
citation: Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
citation: Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
citation: Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
citation: Posner MI, Petersen SE. The attention system of the human brain. Annu Rev Neurosci. 1990;13:25-42. doi: 10.1146/annurev.ne.13.030190.000325. No abstract available.
citation: Godfrey E, Chalder T, Ridsdale L, Seed P, Ogden J. Investigating the active ingredients of cognitive behaviour therapy and counselling for patients with chronic fatigue in primary care: developing a new process measure to assess treatment fidelity and predict outcome. Br J Clin Psychol. 2007 Sep;46(Pt 3):253-72. doi: 10.1348/014466506X147420.
citation: Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17.
citation: Twomey R, Wrightson J, Fletcher H, Avraam S, Ross E, Dekerle J. Exercise-induced Fatigue in Severe Hypoxia after an Intermittent Hypoxic Protocol. Med Sci Sports Exerc. 2017 Dec;49(12):2422-2432. doi: 10.1249/MSS.0000000000001371.