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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Pusan National University Yangsan Hospital Yangsan | Yangsan | Gyeongnam |
Lead Sponsor | Collaborator |
---|---|
Yong-il Shin, MD | Samsung Medical Center |
Korea, Republic of,
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
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 |
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