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

Not Applicable

• Conditions: Brain Activity; Mild Cognitive Impairment; Cerebral Blood Flow; Low-level Light Therapy
• Interventions: Device: Low-level light therapy device

• Registration Number: NCT03192670
• Lead Sponsor: Yong-il Shin, MD

Brief 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

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-18
• Last Update Submitted: 2017-06-18
• Study Start: 2017-06-20
• Study First Posted: 2017-06-20
• Last Update Posted: 2017-06-20
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CA+VA dual stimulation group	Low-level light therapy device	In CA+VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)
CA(Carotid artery)-stimulation group	Low-level light therapy device	In CA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)
VA(Vertebral artery)-stimulation group	Low-level light therapy device	In VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)
Sham control group	Low-level light therapy device	Sham control group received same procedure without LED-T. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D)

Primary Outcome Measures

Name	Time	Method
Neuropsychological Behavioral Assessment 1	Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention	SNSB

Secondary Outcome Measures

Name	Time	Method
Neuropsychological Behavioral Assessment 3	Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention	K-MoCA
Depression assessment	Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention	GDS-SF
Neuroimaging Assessment 1	Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention	fMRI
Neuroimaging Assessment 2	Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention	SPECT
Neuropsychological Behavioral Assessment 2	Baseline, Change from Baseline Corsi-block test at immediately after intervention , Change from Baseline Corsi-block test at 4 weeks after intervention	Corsi-block test
ADL assessment 2	Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention	K-ADL
ADL assessment 1	Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention	K-MBI
Quality of Life assessment	Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention	EQ-5D
Gene test 1	Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention	BNDF
Gene test 2	Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention	ApoE

Trial Locations

Locations (2)

Pusan National University Yangsan Hospital Yangsan; 🇰🇷 Yangsan, Gyeongnam, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of