NCT03192670

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Yong-il Shin, MD · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2017-06-20
• Last updated: 2017-06-20

Locations

2 sites across 1 country: South Korea