A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits

Mild Cognitive Impairment Clinical Trial

Official title: A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits by Enhancing Cerebral Blow Flow

Status Not yet recruiting

Clinical Trial Summary

The primary objective of this study is to confirm and compare the effect of methods of Low-level light therapy (LED-T) in the mild cognitive impairment.

Clinical Trial Description

Total 168 patients were recruited and randomized to receive either real or sham-LED-T. Real experimental groups were divided into three groups; CA group, VA group, CA+VA dual group. Each group received LED-T (30 min) once a day for 30 days. Each groups LED-T positioned at following locations;

• CA group on the superior border of the thyroid cartilage, and anterior to the sternocleidomastoid muscle based on Korea traditional therapy called Inyoung(ST9)

• VA group on the upper abdomen, spinous process of the 2nd cervical vertebra upper margin based on Korea traditional therapy called CunChu

• CA+VA dual group on the CA position (ST9), and VA position (BL10) The patients were initially evaluated at baseline, immediately, 4wks after intervention.

Study type : Interventional Study Phase : Not provided Study Design : Allocation :

Randomized Intervention Model : Parallel Assignment Masking : Single Blind (Investigator) Primary Purpose : Treatment, intervention Condition : Mild cognitive impairment, Health subjects

Intervention :

• Low-level light therapy device (Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter),

• Parameters : Neuroimaging assessement: fMRI, SPECT, Neuropsychological behavioral assessment: SNSB; Seoul Neuropsychological screening battery, K-MoCA, Corsi-block test, K-MBI, K-ADL, GDS, EQ-5D, Neurophysiological assessment: MEP, Motor evoked potential, Gene test(BNDF, ApoE)

Study Arms

• Experimental : Sham control group and real stimulation group.

• In each group, total sessions of the Low-level light therapy (LED-T) was done for intervention was followed after that.

• Subjects received LED-T (30 min) once a day for 30 days.

• The sham control group was kept without LED-T ;

Related Conditions & MeSH terms

• Brain Activity
• Cerebral Blood Flow
• Cognition Disorders
• Low-level Light Therapy
• Mild Cognitive Impairment

• NCT number: NCT03192670
• Study type: Interventional
• Source: Pusan National University
• Contact: Yong-il Shin, M.D, Ph.D
• Phone: 82-55-2872
• Email: rmshin@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2017
• Completion date: December 31, 2019