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

N/AUnknownNCT03192670

Yong-il Shin, MD168 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

168

Conditions

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

Interventions

Low-level light therapy deviceDEVICE

Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects ages older than 55 years old 2. Subjects who has K-MoCA assessment score less than 23 3. Subjects who understand the purpose of the study and acquired the consent of the subjects or caregiver Exclusion Criteria: 1. Subjects who have K-MMSE less than 19 2. Subjects who have pre-existing and present-existing neurological diseases as CNS lesion 3. Subjects who have psychiatric disease such as depression, schizophrenia, bipolar disease, or dementia 4. Subjects who is estimated as not appropriate for the study by the investigators

Locations (2)

Pusan National University Yangsan Hospital Yangsan

Yangsan, Gyeongsangnam-do, South Korea

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Neuropsychological Behavioral Assessment 1

SNSB

Time frame: Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention

Secondary Outcomes

Neuropsychological Behavioral Assessment 2

Corsi-block test

Time frame: Baseline, Change from Baseline Corsi-block test at immediately after intervention , Change from Baseline Corsi-block test at 4 weeks after intervention

Neuropsychological Behavioral Assessment 3

K-MoCA

Time frame: Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention

ADL assessment 1

K-MBI

Time frame: Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention

ADL assessment 2

K-ADL

Time frame: Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention

Depression assessment

GDS-SF

Time frame: Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention

Quality of Life assessment

EQ-5D

Time frame: Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention

Central Contacts

Yong-il Shin, M.D, Ph.D

CONTACT

82-55-2872 rmshin@gmail.com

Data from ClinicalTrials.gov

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