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.
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
;
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