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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
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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.
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;
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 :
Study Arms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Behavioral Assessment 1 | SNSB | Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Neuropsychological Behavioral Assessment 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong-il Shin, M.D, Ph.D | Contact | 82-55-2872 | rmshin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong-il Shin, M.D, Ph.D | Pusan National University Yangsan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital Yangsan | Yangsan | Gyeongsangnam-do | South Korea | |||
| Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28464523 | Background | 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. | |
| 28347821 | 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. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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) |
|
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 | 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 | K-ADL | Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention |
| Depression assessment | 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 | 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 | BNDF | Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention |
| Gene test 2 | ApoE | Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention |
| Neuroimaging Assessment 1 | fMRI | Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention |
| Neuroimaging Assessment 2 | SPECT | Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention |
| Seoul |
| South Korea |
|
| 28164443 | 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. |
| 26889965 | 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. |
| 26797192 | 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. |