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

NCT03192670 | Unknown

• 1 other identifier: PNUYH-03-2017-003, SMC-2016-1
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Neuropsychological Behavioral Assessment 1

  SNSB

  Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention

Secondary Outcomes (10)

• 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

• Neuropsychological Behavioral Assessment 3

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

• ADL assessment 1

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

• ADL assessment 2

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

• Depression assessment

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

Study Arms (4)

Sham control group

SHAM COMPARATOR

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

CA(Carotid artery)-stimulation group

EXPERIMENTAL

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

VA(Vertebral artery)-stimulation group

EXPERIMENTAL

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

CA+VA dual stimulation group

EXPERIMENTAL

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

Interventions

Low-level light therapy device DEVICE

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

CA(Carotid artery)-stimulation group; CA+VA dual stimulation group; Sham control group; VA(Vertebral artery)-stimulation group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ages older than 55 years old
• Subjects who has K-MoCA assessment score less than 23
• Subjects who understand the purpose of the study and acquired the consent of the subjects or caregiver

You may not qualify if:

• Subjects who have K-MMSE less than 19
• Subjects who have pre-existing and present-existing neurological diseases as CNS lesion
• Subjects who have psychiatric disease such as depression, schizophrenia, bipolar disease, or dementia
• Subjects who is estimated as not appropriate for the study by the investigators

Sponsors & Collaborators

• Yong-il Shin, MD: lead
• Samsung Medical Center: collaborator

Study Sites (2)

Pusan National University Yangsan Hospital Yangsan

Yangsan, Gyeongsangnam-do, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (5)

• Lee HI, Lee SW, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Low-level light emitting diode therapy promotes long-term functional recovery after experimental stroke in mice. J Biophotonics. 2017 Dec;10(12):1761-1771. doi: 10.1002/jbio.201700038. Epub 2017 May 2.

  PMID: 28464523 BACKGROUND

• Lee HI, Lee SW, Kim SY, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Pretreatment with light-emitting diode therapy reduces ischemic brain injury in mice through endothelial nitric oxide synthase-dependent mechanisms. Biochem Biophys Res Commun. 2017 May 13;486(4):945-950. doi: 10.1016/j.bbrc.2017.03.131. Epub 2017 Mar 24.

  PMID: 28347821 BACKGROUND

• Lee HI, Lee SW, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Low-level light emitting diode (LED) therapy suppresses inflammasome-mediated brain damage in experimental ischemic stroke. J Biophotonics. 2017 Nov;10(11):1502-1513. doi: 10.1002/jbio.201600244. Epub 2017 Feb 6.

  PMID: 28164443 BACKGROUND

• Lee HI, Park JH, Park MY, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Pre-conditioning with transcranial low-level light therapy reduces neuroinflammation and protects blood-brain barrier after focal cerebral ischemia in mice. Restor Neurol Neurosci. 2016;34(2):201-14. doi: 10.3233/RNN-150559.

  PMID: 26889965 BACKGROUND

• Hong GY, Shin BC, Park SN, Gu YH, Kim NG, Park KJ, Kim SY, Shin YI. Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea. Int J Gynaecol Obstet. 2016 Apr;133(1):37-42. doi: 10.1016/j.ijgo.2015.08.004. Epub 2015 Dec 2.

  PMID: 26797192 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yong-il Shin, M.D, Ph.D

  Pusan National University Yangsan Hospital

  STUDY CHAIR

Central Study Contacts

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

CONTACT

82-55-2872; rmshin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 20, 2017
• Study Start: June 20, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)