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

Adult Clinical Trial

Official title:

Effects of Remote Ischemic Conditioning on Cognitive Function and Blood Oxygen Levels in Unacclimatized Adult at High Altitude

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03728114
• Other study ID #: ERIC-HA
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Lian Duan, MD PHD
• Phone: 861013911365592
• Email: duanlian307[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult

Intervention

Device:
• RIC
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 RIC
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	Xuanwu Hospital, Beijing

References & Publications (8)

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. — View 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. — View 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. — View 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. — View Citation

Posner MI, Petersen SE. The attention system of the human brain. Annu Rev Neurosci. 1990;13:25-42. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline (pre-RIC treatment) at 7days after RIC treatment
Secondary	basic fibroblast growth factor	basic fibroblast growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.	change from baseline (pre-RIC treatment) at 7 days after RIC treatment
Secondary	platelet derived growth factor	platelet derived growth facto will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.	change from baseline (pre-RIC treatment) at 7 days after RIC treatment
Secondary	vascular endothelial growth factor	vascular endothelial growth factor will be detected. Blood samples will be drawn from cubital vein to test these biomarkers.	change from baseline (pre-RIC treatment) at 7 days after RIC treatment
Secondary	the rate of Adverse event	Any adverse event will be reported and its relationship with the RIC intervention will be evaluated.	change from baseline (pre-RIC treatment) at 7 days after RIC treatment
Secondary	distal radial pulses	It is an aspect which can reflect the safety of remote ischemic conditioning	within 7 days after RIC treatment
Secondary	the number of erythema in the skin	It is an aspect which can reflect the safety of remote ischemic conditioning	within 7 days after RIC treatment
Secondary	the number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure	it is an aspect which can reflect the safety of remote ischemic conditioning	within 7 days after RIC treatment
Secondary	the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator.	it is an aspect which can reflect the safety of remote ischemic conditioning	within 7 days after RIC treatment
Secondary	heart rate	the heart rate will be measured by automatic blood pressure monitor	change from baseline(pre-RIC treatment) at 7days after RIC treatment
Secondary	blood pressure	Both systolic, and diastolic pressure will be measured by automatic blood pressure monitor	change from baseline(pre-RIC treatment) at 7days after RIC treatment
Secondary	blood oxygen saturation (SaO2)	The portable oxygen saturation ward apparatus (Datex -Ohmeda, USA) will be used to monitor the blood oxygen saturation (SaO2)	change from baseline(pre-RIC treatment) at 7days after RIC treatment
Secondary	cerebral oxygen saturation(TOI)	The cerebral oxygen monitor (EGOS-600, Jiangsu China) will be used to monitor the cerebral oxygen saturation (TOI).	change from baseline(pre-RIC treatment) at 7days after RIC treatment
Secondary	The peak systolic blood flow velocity (PSV) of bilateral middle cerebral artery (MCA)	This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards	change from baseline(pre-RIC treatment) at 7days after RIC treatment
Secondary	end-diastolic blood flow velocity (EDV) of bilateral middle cerebral artery (MCA)	This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards	change from baseline(pre-RIC treatment) at 7days after RIC treatment
Secondary	the mean flow velocity (MFV) of the subjects' bilateral middle cerebral artery (MCA)	This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards	change from baseline (pre-RIC treatment) at 7 days after RIC treatment
Secondary	pulse index (PI) of the subjects' bilateral middle cerebral artery (MCA)	This is a indicator of hemodynamic data ,it is measured by Transcranial Doppler ((DWL Doppler-Box, German) according to applicational specifications and technical standards	change from baseline (pre-RIC treatment) at 7 days after RIC treatment
Secondary	The degree of palpation of tenderness--visual analogue scale	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)	within 7 days after RIC treatment
Secondary	the number of patients with any other adverse events related to RIC intervention as determined by the principle investigator	it is an aspect which can reflect the safety of remote ischemic conditioning	within 7 days after RIC treatment