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

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ClinicalTrials.gov Identifier: NCT03192670
Recruitment Status : Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Samsung Medical Center
Information provided by (Responsible Party):
Yong-il Shin, MD, Pusan National University

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Cerebral Blood Flow Low-level Light Therapy Brain Activity Device: Low-level light therapy device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits by Enhancing Cerebral Blow Flow
Estimated Study Start Date : June 20, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Gene test 1 [ Time Frame: Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention ]
    BNDF

  8. Gene test 2 [ Time Frame: Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention ]
    ApoE

  9. Neuroimaging Assessment 1 [ Time Frame: Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention ]
    fMRI

  10. Neuroimaging Assessment 2 [ Time Frame: Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention ]
    SPECT



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192670


Contacts
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Contact: Yong-il Shin, M.D, Ph.D 82-55-2872 rmshin@gmail.com

Locations
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Korea, Republic of
Pusan National University Yangsan Hospital Yangsan
Yangsan, Gyeongnam, Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Yun-Hee Kim, M.D, Ph.D.    82-2-3410-2824    yun1225.kim@samsung.com   
Contact: Ahee Lee    82-2-6007-5408    ahee.lee@gmail.com   
Sponsors and Collaborators
Yong-il Shin, MD
Samsung Medical Center
Investigators
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Study Chair: Yong-il Shin, M.D, Ph.D Pusan National University Yangsan Hospital

Publications:
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Responsible Party: Yong-il Shin, MD, Professor, Pusan National University
ClinicalTrials.gov Identifier: NCT03192670     History of Changes
Other Study ID Numbers: PNUYH-03-2017-003, SMC-2016-1
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders