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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03192670
• Other study ID #: PNUYH-03-2017-003, SMC-2016-1
• Status: Not yet recruiting
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 18, 2017
• Start date: June 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2017
• Source: Pusan National University
• Contact: Yong-il Shin, M.D, Ph.D
• Phone: 82-55-2872
• Email: rmshin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital Yangsan	Yangsan	Gyeongnam

Sponsors (2)

Lead Sponsor	Collaborator
Yong-il Shin, MD	Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

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 Feb 6. doi: 10.1002/jbio.201600244. [Epub ahead of print] — View Citation

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 May 2. doi: 10.1002/jbio.201700038. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological Behavioral Assessment 1	SNSB	Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention
Secondary	Neuropsychological Behavioral Assessment 2	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
Secondary	Neuropsychological Behavioral Assessment 3	K-MoCA	Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention
Secondary	ADL assessment 1	K-MBI	Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention
Secondary	ADL assessment 2	K-ADL	Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention
Secondary	Depression assessment	GDS-SF	Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention
Secondary	Quality of Life assessment	EQ-5D	Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention
Secondary	Gene test 1	BNDF	Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention
Secondary	Gene test 2	ApoE	Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention
Secondary	Neuroimaging Assessment 1	fMRI	Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention
Secondary	Neuroimaging Assessment 2	SPECT	Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention