Clinical trial NCT03192670: A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits
Official title: A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits by Enhancing Cerebral Blow Flow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Cerebral Blood Flow
Low-level Light Therapy
Brain Activity
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
First posted: 2017-06-20
Enrollment: 168
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Neuropsychological Behavioral Assessment 1
timeFrame: Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention
Secondary outcomes:
measure: Neuropsychological Behavioral Assessment 2
timeFrame: Baseline, Change from Baseline Corsi-block test at immediately after intervention , Change from Baseline Corsi-block test at 4 weeks after intervention
measure: Neuropsychological Behavioral Assessment 3
timeFrame: Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention
measure: ADL assessment 1
timeFrame: Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention
measure: ADL assessment 2
timeFrame: Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention
measure: Depression assessment
timeFrame: Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention
measure: Quality of Life assessment
timeFrame: Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention
measure: Gene test 1
timeFrame: Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention
measure: Gene test 2
timeFrame: Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention
measure: Neuroimaging Assessment 1
timeFrame: Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention
measure: Neuroimaging Assessment 2
timeFrame: Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital Yangsan
state: Gyeongnam
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-il Shin, M.D, Ph.D
role: STUDY_CHAIR
References:
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 Dec;10(12):1761-1771. doi: 10.1002/jbio.201700038. Epub 2017 May 2.
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.
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 Nov;10(11):1502-1513. doi: 10.1002/jbio.201600244. Epub 2017 Feb 6.
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.
citation: 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.