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

June 18, 2017 updated by: Yong-il Shin, MD

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yong-il Shin, M.D, Ph.D
  • Phone Number: 82-55-2872
  • Email: rmshin@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
    • Gyeongnam
      • Yangsan, Gyeongnam, Korea, Republic of
        • Pusan National University Yangsan Hospital Yangsan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham control group
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)
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
Experimental: CA(Carotid artery)-stimulation group

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)
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
Experimental: VA(Vertebral artery)-stimulation group

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)
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
Experimental: CA+VA dual stimulation group

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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological Behavioral Assessment 1
Time Frame: Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention
SNSB
Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological Behavioral Assessment 2
Time Frame: 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
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
Time Frame: Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention
K-MoCA
Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention
ADL assessment 1
Time Frame: Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention
K-MBI
Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention
ADL assessment 2
Time Frame: Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention
K-ADL
Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention
Depression assessment
Time Frame: Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention
GDS-SF
Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention
Quality of Life assessment
Time Frame: Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention
EQ-5D
Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention
Gene test 1
Time Frame: Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention
BNDF
Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention
Gene test 2
Time Frame: Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention
ApoE
Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention
Neuroimaging Assessment 1
Time Frame: Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention
fMRI
Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention
Neuroimaging Assessment 2
Time Frame: Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention
SPECT
Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yong-il Shin, MD

Collaborators

Samsung Medical Center

Investigators

  • Study Chair: Yong-il Shin, M.D, Ph.D, Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 20, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 18, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 18, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNUYH-03-2017-003, SMC-2016-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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